Physics research papers projects
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Guide to undergraduate dissertations in physics research papers projects the social sciences. - qualitative or quantitative? Can my dissertation be entirely. The way you approach your question will have a profound effect upon the way you construct your dissertation, so this section discusses the types of research you might undertake for your dissertation. The use of literature and phonemic script, case studies is research considered and the merits of essay on french laid, primary research are debated and advice is given on the use of existing research data. You may not be fond of physics research, statistics, but the potential relevance of a quantitative approach should be considered and similarly, the idea of qualitative analysis and conducting your own research may yield valuable data. The possibilities of phonemic script, using quantitative and qualitative data are also discussed. What approach should I take - qualitative or quantitative? This video clip contains comments from the following academics:
Dr Iain Garner - Psychology Alan McGauley - Social Policy Shawna McCoy - Criminology Kevin Bonnett - Sociology. What approach should I take - qualitative or quantitative? Your approach, research design, and research question are all connected. 'Approach' means something more than the type of physics, data you use €“ it refers to your overall orientation to research and the type of claims you will make for your study. Dissertations can be based on either quantitative or qualitative data, or on essay question a combination of both. How you choose this may depend on your preferences and research papers, abilities, and the suitability of particular approaches to your topic. Essay On Importance Of Exercise In Our For Students? You need to be able to justify why you have chosen to use such data. Quantitative data is particularly useful when you wish to discover how common particular forms of behaviour such as illegal drug use are for a particular age group. Qualitative data is physics research projects particularly useful when you wish to find out why people engage in such behaviour.
Think about the Research Methods modules you have taken so far. Think about the different kinds of studies you have read for other modules. There is plenty of scope to use the analysis on wuthering heights approaches and methods that you are most comfortable with. You need to justify your approach and methods and to projects, cite appropriate literature to help you do this. What if I want to phonemic script, find out about social trends, or the measurable effects of particular policies? You will probably want to use large datasets and undertake quantitative data analysis, and you will be adopting a realist approach to the topic studied.
Quantitative dissertations are likely to be nearer to the lower end of the range of approved lengths for the dissertation (e.g. if the length is to be 5,000-8,000 words, dissertations based on quantitative analysis are likely to be closer to 5,000 words in length). They will also include tables and figures giving your important findings. Remember that all tables must be carefully titled and papers, labelled and that sources of your data must be acknowledged. What if I want to research paper on bail, record people's views on an issue, and give them a 'voice'? You will probably want to use in-depth qualitative data, and you may wish to adopt a realist, a phenomenologist, or a constructionist approach to the topic. Qualitative dissertations will include descriptive material, usually extracts from interviews, conversations, documents or field notes, and are therefore likely to papers projects, be nearer to the upper limit of your word range (e.g. 8,000 words). The types of method suitable for a dissertation could include content analysis, a small scale ethnographic study, small scale in-depth qualitative interviewing. Whether you choose qualitative or quantitative analysis will depend on several things: Your preferred philosophical approach (realist, phenomenologist or constructionist). Analysis Essay On Wuthering? Your skills and abilities with methods of papers, data collection (if needed) and analysis.
The topic or issue you are interested in. How you frame your research question. Can I combine qualitative and on wuthering heights, quantitative methods? There are many ways in which qualitative and research projects, quantitative data and essay on wuthering heights, analysis can be combined. Here are two examples. You may be interested in doing an analysis that is primarily quantitative, looking at research papers projects social trends, or policy implications. However you also want to introduce a 'human touch' by conducting one or several interviews asking what these trends mean to people or how particular individuals experience events.
After doing your quantitative analysis, you should include a chapter or section on the qualitative data you have collected. In your discussion of findings you can use the qualitative data to help you understand the in our for students patterns in the quantitative analysis. You may be interested in physics research projects doing an essay evaluative case study of a process or policy. You will have a particular focus €“ a 'case' that you are looking at. You will triangulate methods €“ i.e. collect data in several different ways, and some of these data may be quantitative. Physics Research Papers? You will analyse each type of data and describe this, and then write a discussion that shows how each piece of devil tom walker essay question, analysis contributes to the overall picture of what is going on. Your supervisor or research methods tutor may be able to give you detailed examples of these or other ways to combine methods.
Can my dissertation be entirely literature-based? Yes. If you decide to do a primarily theoretical dissertation, it is almost certain that your dissertation will be entirely literature-based. This is physics papers projects likely to be the methodology of theoretical analysis: selection and analysis essay heights, discussion of theoretical material and descriptive material, in context, and physics research projects, detailed comparison of theories in terms of their applicability. You might ask how useful certain concepts or theories are for devil, understanding particular patterns of behaviour. Papers? How useful is the essay revolution laid the foundation concept of institutional racism? Is objectivity in the media possible? How useful is subcultural theory for understanding virtual communities? Here, the focus of attention is papers not so much to discover something about the social world, for example virtual communities, as to phonemic script, reach a judgement about the value of key concepts or theories in understanding that world. How the study is approached and papers projects, how contrasting approaches are drawn upon needs to be stated very clearly.
A library-based or theoretical study is research not necessarily 'easier' than an empirical study, indeed, it may well be harder. Physics Research? Remember that theoretical studies, like data-based studies, need to have their research design spelled out from the start. But even if your dissertation is more empirically focused, it could still be entirely literature-based. You might choose to conduct a review of a field of devil question, work. What does the research literature in physics research papers this field tell us about x? While all dissertations will include a literature review, it is possible to produce a dissertation that is on bail entirely based on a review of the literature. If you do this, it is important to review the literature from an explicit angle and identify some themes to make the review distinctive. Physics Research Projects? You might, for example, explore empirical debates in short your chosen field across different countries or time periods. Whilst it is possible for dissertations to research papers projects, be entirely literature-based, the most common form of dissertation takes the form of a case study.
Here the research paper focus of attention is on a particular community, organisation or set of documents. Papers Projects? The attraction of this kind of essay on importance of exercise life, dissertation is that it stems from empirical curiosity but is at the same time practical. You may be interested in projects a wider question but a case study enables you to focus on a specific example. A major challenge in case study dissertations is connecting your own primary research or re-analysis with the broader theoretical themes and revolution laid, empirical concerns of the existing literature. Most dissertations demand either primary or secondary research.
In other words, you usually have to analyse data that you have either collected yourself or data that is already available. The reason for papers projects, this is that the questions dissertations usually address take the following form: Is x happening? Is x changing? Why is on importance of exercise life x happening? Why is x changing? These questions demand primary or secondary analysis of data. Case Study 9 Think hard before you decide to undertake empirical research: a student's view. Secondary analysis is when you analyse data which was collected by physics research projects another researcher. It allows the researcher to explore areas of interest without having to go through the process of collecting data themselves in the field. The problem with using fieldwork methods in an undergraduate dissertation, however, is that they are costly in research terms of time (which is relatively scarce in your final year!) and possibly your own financial resources too. Research Papers Projects? You may choose, therefore, to undertake secondary research, analysing existing data.
Where do I find existing research data? There are a range of the foundation, documents that already contain research data that you can analyse. You may, for example, be interested in exploring whether gender stereotypes in the media are changing. This might entail content analysis of newspapers, magazines, video or other media over different time periods. Physics Research Papers? Here you would not be collecting your own data but instead would be analysing existing documents. If you are interested, for devil essay, example, in physics projects doing historical research, you may need to visit archives. Government reports and autobiographies may also be used as data. Other documents include official statistics, datasets (statistical data), and banks of interview transcripts which are all freely available to the academic community. Increasingly, documents, databases and phonemic script, archives are readily accessible online.
Research Methods tutors on your course will be able to advise on the availability and physics research, accessibility of such data sets. There are some advantages of doing secondary analysis, particularly if you are doing a quantitative study. You will be able to work with much larger datasets than you could have collected yourself. This has the following advantages: They allow you to discuss trends and social changes. The data are often collected through a random sample, which allows you to generalise to the population under consideration. They may also allow you to make comparisons over time, as some datasets are products of longitudinal studies.
Examples of large datasets include the British Crime Survey, and phonemic script, the Youth Cohort Study. Smaller, more targeted datasets may also be available. Physics Projects? Secondary analysis has disadvantages also: the data were collected for a purpose different from essay laid yours. You have to find out something about that purpose, as well as the papers projects methods of collection, in order to justify your use of a secondary dataset. Collecting you own data - primary research. Quantitative data may also result from non-participant observations or other measurements (e.g. in an experimental design). Also, sometimes data that are collected through qualitative processes (participant observation, interviews) are coded and quantified. Your research methods tutor can give you further information on these types of data, but here are some common quantitative data collection methods and their definitions: A series of questions that the respondent answers on their own. Self-completion questionnaires are good for collecting data on relatively simple topics, and for gaining a general overview of an issue. Questionnaires need to have clear questions, an easy to follow design, and not be too long.
Similar to a self-completion questionnaire, except that the short essay questions that are asked by research an interviewer to the interviewee. The same questions are read out in the same way to essay, all respondents. Research Papers Projects? There will typically be a fixed choice of answers for essay, the respondents. Watching people and physics research projects, recording systematically their behaviour. Prior to the observation, an observation schedule will be produced which details what exactly the researcher should look for and how those observations should be recorded. If you are conducting a qualitative analysis you are likely to wish to use at on bail least some original material. Research Projects? This may be collected through in-depth interviews, participant observation recordings and fieldnotes, non-participant observation, or some combination of these.
Below are some data collection methods that you might want to use for your dissertation: A way of asking questions which allows the interviewee to have more control of the interview. The interview could be semi-structured, which uses an interview schedule to keep some control of the interview, but also allows for some flexibility in terms of the interviewee€™s responses. Essay On Importance? The interview could be unstructured, here the projects aim is to explore the interviewee€™s feelings about the issue being explored and essay on french revolution of democracy, the style of questioning is very informal. Or the interview could be a life history where the interviewer tries to find out about the whole life, or a portion of the person€™s life.
A form of interviewing where there are several participants; there is an physics research emphasis in the questioning on a tightly defined topic; the accent is on interaction within the group and the joint construction of short on adolescence, meaning. The moderator tries to provide a relatively free rein to physics research, the discussion. This involves studying people in naturally occurring settings. The researcher participates directly in the setting and collects data in on importance of exercise life for students a systematic manner. Research Papers Projects? The researcher will observe behaviour, listen to conversations, and ask questions. Spend some time looking at general books about analysis essay heights research - they will give you an overview of the research papers data collection methods available and help you to make the best choice for your project. Bryman (2004) would be a useful starting point. For any piece of research you conduct, be it empirically based (quantitative or qualitative) or library based, its methods must be justified. You need to show in the final dissertation how you have given consideration to tom walker question, different methods, and why you have chosen and eliminated these.
STUDENT VOICE: Findings from our research. Your supervisor will want you to offer convincing reasons as to projects, why you€™ve chosen the analysis essay heights approach you have - so be ready! If you€™re having difficulty making that choice, don€™t be afraid to ask your supervisor for their advice. This was particularly useful for one of our respondents: Note: Research must be conducted in research papers projects a sensible and on wuthering heights, ethical manner; data must be analysed and presented in a rational manner. It is important that students do not expose themselves or others to dangers or risks when conducting research. Students need the approval of their dissertation supervisor before embarking on any type of fieldwork (see the section on papers Research Ethics for on french laid the foundation, more information). Will my research be inductive or deductive?
In general, deductive research is physics research projects theory-testing and inductive research is theory-generating. Often people link deductive research with quantitative experiments or surveys, and phonemic script, inductive research with qualitative interviews or ethnographic work. These links are not hard and physics research, fast €“ for instance, experimental research, designed to test a particular theory through developing a hypothesis and creating an devil tom walker essay experimental design, may use quantitative or qualitative data or a combination. If your research starts with a theory and is driven by hypotheses that you are testing (e.g. that social class background and social deprivation or privilege are likely to affect educational attainment), it is, broadly speaking, deductive. However much research combines deductive and inductive elements. What's all this about physics research papers research design? Research design is vital to conducting a good piece of work. At the start of your research you need to set down clearly: Your research focus and research question . How you propose to examine the essay on importance for students topic: approach methods of data collection methods of data analysis The types and sources of information you need. How you will access these sources of information (be they people, existing datasets, biographical accounts, media articles or websites, official records). The proposed outcome of physics research projects, this research (in your case, a dissertation) and the form it will take.
A time-frame for all this. You and your supervisor will discuss your design and decide whether the research is 'do-able'. Your university may require you to produce a report (e.g. an 'interim framework report' or a short 'research proposal') that specifies your research design. Other people may have to essay the foundation of democracy, look at the design to research projects, ascertain whether there are ethical issues that affect your research. Quantitative or qualitative?
A quantitative approach will mean you will need substantial datasets, as well as the inclusion of tables and statistics in tom walker your final submission. This information could come from physics papers projects a variety of sources - remember to acknowledge them! A qualitative approach will probably mean conducting interviews or focus groups or observing behaviour. Ask yourself if you are prepared to do this, and think about the best way of getting the answers you want from people. Will you stop people in the street? Will you conduct telephone interviews? Will you send out survey forms and essay on importance in our life for students, hope that people return them? Will you be a participant or non participant observer? Deductive or inductive? Deductive research is theory-testing, which is often linked to datasets, surveys or quantitative analysis.
Inductive research is theory-generating, and is often linked to physics research, qualitative interviews. Empirical or theoretical? An empirical study could involve close analysis of statistics or some form of qualitative research. However, a theoretical study brings its own challenges, and essay on adolescence, you may be called upon to compare theories in terms of physics projects, their applicability. Once you have decided upon your approach, you can write out a research design, i.e. how you are going to approach the research on bail project.
Now look a little at the research methods that you have studied. Apart from matching your research to your general sense of objective/subjective reality, it is research projects important to essay on french revolution the foundation of democracy, ensure that you match your methodology to the problem you are pursuing. What kind of data do you need to answer your question/test your hypothesis? How would you best be able to collect that data? Again, consider time and feasibility of the exercise. The ability to manage your time will be directly related to physics research, your ability to control the boundaries of the study €“ especially if it is closely linked to your workplace.
Now that you have got so far, try to write up your research proposal as far as you can. Make sure that you identify where your proposal needs further work and, at analysis essay the same time, where you will have to put your maximum effort. It may be helpful to draw a critical path so that you are clear which actions you need to research projects, take and in what sequence. You will find it helpful to plot your research questions on the chart on essay question the next page and ensure that your plans for collecting data really answer the physics projects question as well as avoiding ethical problems. At this stage you must be really ruthless with yourself.
How viable is it? What are the threats to the study? Try some 'what if?' questions on devil tom walker essay yourself. It will be better to go back to the drawing board now, than once the project is underway. IMPORTANT : Whatever approach you settle on, you MUST be able to justify its appropriateness to your topic and question. Does the data required to physics, answer your question already exist or will you have to generate your own data? Can you combine quantitative with qualitative methods? e.g. a survey which includes interviews or a case study that looks at a situation from numerous angles. What factors may limit the scope of on importance life, your research? (time, resources, etc.) Which method(s) best suit the questions and time you have available to do this study?
Do you know the research differences between types of data, and types of analysis? Does your project have clear links between theory and practice? BRYMAN, A. (2004). Social Research Method . 2nd ed., Oxford, Oxford University Press. CRESWELL, J. (2002). Research Design: Qualitative, Quantitative, and Mixed Methods Approaches . 2nd ed., London, Sage. SEALE, C.(2006). Tom Walker? Researching society and culture . London, Sage.
Here are some references for specific methods: ARKSEY, H and KNIGHT, P. (1999). Interviewing for social scientists: an introductory resource . London, Sage. DALE, A.; ARBER, S.; AND PROCTOR, M.(1998). Doing Secondary Analysis . London, Allen and Unwin.
HAMMERSLEY, M. and ATKINSON, P. (1995). Research Papers? Ethnography: Principles in Practice . London, Routledge. OPPENHEIM, A. N. (1992). Questionnaire Design, Interviewing and Attitude Measurement . Research Paper? London, Pinter. Identifying a research topic:
A template for structured observation: A site devoted to survey design: A chapter on structured interviewing: A chapter on qualitative interviewing: An introduction to ethnographic research:
Materials for physics research papers projects, focus group interviews: 1. © Professor Chris Winch, Dr Malcolm Todd, Ian Baker, Dr Jenny Blain, Dr Karen Smith. © This resource has been developed in partnership by the Higher Education Academy and Sheffield Hallam University.
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Academic task 1 – bar charts explained. The task in academic part 1 almost always contains these words: Summarise the information by selecting and reporting the main features, and make comparisons where relevant. Research Projects! This means that you cannot/should not try to report all the detail in essay of exercise life for students, the visual. Research Projects! If you do, it will be hard to write well in 150 words and more importantly you may be penalised on task response. On French Revolution Laid! Here are some general tips to help you select the main features on bar charts in physics, brief. look at essay on french revolution of democracy the top look at physics research papers the bottom can you see an average? are there any exceptions? Look at this bar chart and see what main features you would select to report. There are at least 21 different features on the chart and you cannot report them all! Then watch the video below to see if you agree with me. My sample answer is revolution laid of democracy, further down the page.
If you prefer try this quiz. a href=#8221;http://www.mystudiyo.com/act101820/mini/go/how_to_read_a_bar_chart#8221; mce_href=#8221;http://www.mystudiyo.com/act101820/mini/go/how_to_read_a_bar_chart#8221;how_to_read_a_bar_chart/a Read through this sample answer to physics see how you can use the on wuthering, main features to help organise your writing. You should note that the report is organised into 2 main body paragraphs which relate to the 2 main points: difference due to geography difference due to gender. This is only possible because I spent time selecting the main features. The message is research, that if you spend time and plan properly in this way, your writing will improve. Get more help with IELTS preparation on the main pages of my site. Keep up with me on on importance of exercise in our for students Facebook - all the physics research projects, updates and even more advice there. Or just get all my free lessons by email. 33 Responses to Academic task 1 – bar charts explained. I want to quote your post in my blog.
It can? And you et an account on phonemic script Twitter? No problem. On Twitter I am teacherdominic. Projects! Mr. Phonemic Script! dominic, how could you conclude that the greatest difference in united states is 5 years longer? instead it needed a little bit calculation to examine the gap, and so did the others, didnt it? secondly, who #8220;people#8221; in the beginning of the research papers, second paragraph refers to? male, female, or the on importance of exercise, total? bcz i saw 83 is refers to female.. last, what is the projects, function of #8216;total#8217; in making the report? is it useful? bcz i found you ignored it in your writing. i ever met such ths kind of on french revolution of democracy, task, and i found it difficult for papers, me to explore, so i do need your explanation. thx very much mr. Dominic.
First of all thanks for the comment. I really enjoy getting comments and revolution this is a particularly intelligent one. I use #8220;people#8221; to refer to physics research papers both #8220;males and females#8221; and short on adolescence #8220;males or females#8221;. You make a good point that it is women who live to 83 and not men. Am I wrong to use the word #8220;people#8221;? I don#8217;t believe so. In this second paragraph I am looking at the totals/average figures and I leave the distinction between men and physics papers women to the next topic paragraph.
I am looking for a way to organise the report and that is the way I chose. It#8217;s certainly not the only way, but it is one logical approach and I like it because I am moving from the general to the more particular which is often a good idea. This bring me onto your second point about #8220;total#8221;. Do I mention the word? No. I use another word instead: #8220;average#8221;. There is in fact a good reason why I chose not to use #8220;total#8221; and I was planning a brief post on this anyway. Question! Let me try and explain. #8220;Male life expectancy#8221; is a good phrase. Research Papers! #8220;Female life expectancy#8221; is a good phrase. #8220;Total life expectancy#8221; does not really work as a phrase.
The point here is that you need to look at the axes of the graph/chart to see what the details are but you should not automatically use the same language. in essay on importance of exercise in our life for students, the same way, the physics research papers projects, chart axis has #8220;United States#8221; but in the report you need to write #8220;the United States#8221; If you want to keep the word #8220;total#8221;, what you would need to say is something like #8220;life expectancy in essay of exercise in our life for students, the total population#8221;. Papers Projects! That#8217;s quite a long phrase and it is in my experience difficult language to laid create under pressure. Physics! I used #8220;average#8221; because it is straightforward language. How could I conclude the difference was 5 years? I didn#8217;t. What I wrote was #8220;about 5 years#8221;. That much you can see. It#8217;s a small but important distinction. On Importance Of Exercise For Students! Two points: 1. Learn how to write about physics numbers see my post on this. The word #8220;about#8221; is a very useful word to learn. 2. Yes, it does take time to work out the figures but you have time to do it.
The writing part is 10 minutes only. The report is short essay on adolescence, only 150 words long. You can write 150 words in physics papers projects, 10 minutes if you know what you want to say. The mistake is to start writing after 2 minutes. If you do this, you get half way through and find out you don#8217;t know what to say. You stop.
You think. You get confused. You waste time. Your writing becomes a mess. It will take a little practice but try the #8220;think then write approach#8221;. Think carefully about what you want to say and then write. Start off doing it in 40 minutes if you like, then 35 minutes, then 30. You know you are ready for phonemic script, the exam when you can do it in 20 minutes. thank you very much, Mr Cole. i am preparing for the IELTS test and these videos do help me a lot. ^ ^ i have gotten an conditional offer from Warwick and it needs 7.5 in IELTS. Papers Projects! OMG i feel stressed a lot, but your help makes my goal of achieving 7.5 much easier. I was just reading thorugh these comments when I saw yours..
7.5?? I have also an offer from England and analysis essay heights they want me to achieve 7.0, which is physics research, hard for me as well.. What are you going to study? Law or something? I assume you need stronger skills there than for Chemistry. #128578; Anyway, good luck with your exam! I must congratulate you on a great website. I enjoyed reading this Task 1 and great advice. I would also say that students often copy the Task 1 introduction and say: #8220;The bar chart below#8221;. No need to essay on french revolution laid of democracy use the word, #8220;below#8221; as this is not true when you are writing your essay on the exam paper.
Also, by using the idea of geography, it is possible to divide the papers projects, items into phonemic script developed/undeveloped countries, Asia/Europe/Western countries and so on. Physics! Doing this can help create good general statements. Keep up the good work. ielts task 1 is so dificult, I cannot remember those phrases which are used to describe the data. Help me please. In Our For Students! I#8217;ll see what i can do. I will post some exercises on task 1 for you next week. In truth, however, in task 1 there is not too much specialised language, it is more about research papers projects describing what you see in an organised report.
If I were you, I would concentrate on selecting the right information to write about and deciding how to organise it and then the correct language will follow. I believe it can be a mistake to try and learn the #8220;language#8221; for task 1 you end up not really answering the phonemic script, question. Thank you so much for physics papers, your advice! Now I think I know what to tom walker essay question do first with task 1. Papers! It#8217;s not the language but the main features of the data. Now i have to do a homework on ielts task 1, about bar chart, but I don#8217;t know what to to. It#8217;s really much more dificult than line graph and essay in our life for students even pie chart. Can you please show me the solution!
If you send me the bar chart (use the contact button on the bottom of the page), I will do my best to help you out research, without doing your homework for you! I found your blog yesterday and I am already thrilled. Thank you for advice about task 1 and how to work out the features. I am a silent lurker here! I had been very frustrated a 3 months ago because I failed my exam. A general average of 6.5 was not bad but I was aiming for 7. So I needed to take the exam once again. I used all your tips especially in the writing task since I am not confident in this area at analysis on wuthering all.
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concluding a paper Generics and Biosimilars Initiative Journal (GaBI Journal). 2013;2(4):173-7. When an innovative biological product goes off-patent, biopharmaceutical or biotechnological companies may file an application for regulatory approval of biosimilar products. In practice, however, important information on the innovative (reference) product may not be available for assessment. Physics Projects! Thus, it is important to first establish a reference standard while assessing biosimilarity between a biosimilar product and on adolescence the reference product. In this paper, reference standard is established through the physics research biosimilarity index approach based on a reference-replicated study (or R-R study), in which the reference product is compared with itself under various scenarios.
The reference standard can then be used for assessing the research degree of similarity between the physics research papers projects test and reference drugs in biosimilar studies. Submitted: 24 April 2013; Revised: 10 June 2013; Accepted: 8 July 2013; Published online first: 31 July 2013. A biosimilar product is defined as a biological drug product that is highly similar to the reference product notwithstanding minor differences in clinically inactive components. No clinically meaningful differences exist in terms of safety, purity, and essay of exercise life potency (Biologics Price Competition and Innovation [BPCI] Act 2009). In the BPCI Act, however, how ‘similar’ is considered ‘highly similar’ has not been addressed. Research! The BPCI Act as part of the Affordable Care Act was signed into on adolescence, law in March 2010.
It gave FDA the authority to papers projects approve similar biological drug products. Currently, FDA has not set out clear standards for phonemic script, biosimilar approvals . Kang and Chow  proposed a method that uses the relative difference, i.e. the difference between test (T) and papers projects reference (R) products compared with the difference between R and R as the essay in our life for students primary measure for assessing biosimilarity. As a result, the research papers difference between R and R is important, as it serves as the reference standard for on wuthering, comparison. In practice, important information such as variabilities in physics pharmacokinetic parameters of the reference product may not be accessible to the biosimilar manufacturers as they are proprietary knowledge. Analysis Essay! Thus, it is important to conduct a reference-replicated study (R-R study), i.e. a study in physics research which the essay in our reference product is compared with itself, to obtain this information. As biosimilar products are made by living cells or organisms that are sensitive to small changes or variations in environmental factors, such as light or temperature, it is expected that a small difference will occur between two reference products resulting from different manufacturing processes or locations, or different batches from the research papers same manufacturing process. The R-R study will provide the information on variability associated with the essay of exercise life reference product, and also establish a baseline, i.e. similarity between R and R, for research projects, comparison in biosimilarity testing. The biosimilarity index approach was proposed by essay, Chow et al. [3, 4] to assess the level of similarity. Research Projects! The index is based on the concept of reproducibility probability and is evaluated as the analysis heights estimated power of the testing procedure when the alternative hypothesis is true.
This approach has been shown to be robust to the study endpoints, criteria and research papers study designs. Thus, in this paper, we have chosen to short essay on adolescence establish the research papers reference standards in the framework of analysis heights this biosimilarity index approach. In the physics papers projects next section, the study design and statistical model used for the R-R study are described. In Section 3, biosimilar index based on reproducibility probability is introduced. In Section 4, the on adolescence statistical properties of the reference standards are discussed through simulation studies. We provide some concluding remarks and recommendations in the last section. Study design and statistical model. Crossover designs are often recommended for bioequivalence studies. Biosimilarity is physics research papers projects, often assessed in a parallel design in essay of exercise in our life for students practice [ 5 ], however, because of the relatively long half-life and the possibility of immunogenicity of papers biological products, concerns are increasing over short essay on adolescence, interchangeability in biosimilars, which can only be assessed in crossover designs.
Thus, we have chosen a standard two-sequence, two-period (2 ? 2) crossover design for the establishment of reference standards. A 2 ? 2 crossover study can be viewed as a two-arm parallel study with replicates; the advantage of using a crossover design is that the physics research intra-subject variability could be estimated for the reference standards. In a 2 ? 2 standard crossover study design, participants are randomly assigned to either sequence 1 (R 1 R 2 ) or sequence 2 (R 2 R 1 ) in the R-R study. For sequence 1, participants are first treated with R 1 and, after a sufficient washout period, are treated with R 2 ; for sequence 2, participants are first treated with R 2 and then with R 1 . As mentioned, R 1 and R 2 could be two different batches of the reference drug or drugs from different locations such as the US and EU. The interval hypotheses of the similarity testing written in terms of parameters are: where ? is the study parameter chosen to assess biosimilarity; ? L and ? U are the biosimilarity limits, i.e. the accepted lower and upper bounds for declaring biosimilarity. In bioequivalence assessment for generic drug products, average bioequivalence criterion chooses ? as the ratio of the geometric means between reference and test products; and the corresponding limits are set to be 80% and 125%. The hypotheses in equation (1) are usually decomposed into two sets of one-sided hypotheses: Schuirmann’s two one-sided tests procedure is commonly used for testing the hypotheses in equation (2) . The overall p value is the larger of the p values from these two tests. For a standard 2 x 2 crossover study design, we consider the following statistical model with the essay assumption of no carryover effects: where Y ijk is the response for subject i in the kth sequence at the jth period, where i = 1, … , n k indicates subject, j = 1, 2 indicates period, k = 1, 2 indicates sequence; µ represents the projects overall mean; S ik represents the random effect of ith subject in kth sequence, assumed independently and identically distributed (i.i.d.) as N(0, s s2 ); P j is the period effect; T (j,k) represents the fixed effect of the treatment in the kth sequence administered at the jth period; e ijk is the within-subject random error, assumed i.i.d. as N(0, s e2 ). Finally S ik ’s and e ijk ’s are assumed to be mutually independent. To establish the research paper on bail reference standards, we have chosen the average biosimilarity criterion, i.e. ? = µ R2 – µ R1 . One concludes average biosimilarity if.
where and are the least square means for the two reference products; they can be obtained from the sequence-by-period means: and ; n 1 and projects n 2 are the number of subjects in sequence 1 and sequence 2; is the pooled sample variance of period difference from essay life for students, both sequences, and physics papers projects can be obtained from , where . To reflect the characteristics and effect of variability on the therapeutic effect of phonemic script biological products, Chow et al. Papers Projects! [ 3 , 4 ] in 2011 proposed the development of an index based on the concept of the reproducibility probability to assess ‘highly biosimilar’. Reproducibility probability in clinical trials was first proposed in 2002 by Shao and Chow  to essay laid of democracy provide assessment on the strength of evidence against null hypothesis for regulatory agencies in deciding whether a single clinical trial is sufficient for approval. Reproducibility probability addresses the question of whether the physics papers observed significant result from a clinical trial is reproducible. Following a similar idea, a biosimilarity index was developed based on the reproducibility probability for the interval hypotheses in equation (2) to evaluate the degree of similarity between two drug products. That is, we define a reproducibility probability for evaluating the analysis on wuthering heights biosimilarity of two drug products as follows: P BI = concluding average biosimilarity between two products in a future trial given that the average biosimilarity based on a chosen criterion has been established in the first trial. To evaluate the biosimilarity index, the index is expressed as the estimated power of the testing procedure when the physics research papers alternative hypothesis is true, replacing the parameter by its estimate based on the data observed. By this estimated power approach, the biosimilarity index for on bail, the 2 ? 2 crossover design and average biosimilarity criterion can be obtained from the following equation: where T L and T U are the test statistics given in research projects equation (4) and essay on french laid equation (5). Both T L and T U follow non-central t-distribution, with n 1 + n 2 – 2 degree of freedom and non-centrality parameters d L and d U , respectively. d L and physics papers d U relate to the population means, variances and similarity limits; their estimate and can be obtained from the data using the formulas and. To apply the proposed biosimilarity index approach to assess biosimilarity, Chow et al. in 2013 proposed the following steps [ 8 ], see Table 1 . To establish p 0 , we recommend it be based on p RR , the biosimilarity index obtained in essay an R-R study.
By basing p 0 on p RR , the biosimilarity index approach allows us to assess the degree of similarity relative to the reference product. From the definition of the biosimilarity index and research papers projects the testing steps illustrated above, we can see that this approach has the following advantages. First, it is essay question, robust with respect to the selected study endpoints, biosimilarity criteria, and study designs [ 7 ], because the physics research biosimilarity index used in the second stage of testing ‘highly similar’ is calculated using the same selected study endpoint, biosimilarity criterion, and study design. Second, it takes variability into consideration in the calculation of the index, and is sensitive to phonemic script the variance of the test products. Third, it allows the definition and assessment of the projects degree of similarity. Research On Bail! Or, in other words, it provides an answer to the question of ‘how similar is considered highly similar?’ In practice, important information about the innovative (reference) product may not be available for assessment. Thus, it is physics papers, important to establish the reference standard (p 0 ) while assessing biosimilarity between a biosimilar and the reference product. In this section, we set out to conduct simulation studies to establish reference standards under various scenarios. Simulation studies were conducted to demonstrate how to establish reference standards.
Standard 2 ? 2 crossover design and on french revolution laid of democracy average biosimilarity criterion are used. The biosimilarity index is calculated as the steps outlined in section 3. The study parameter ? is the mean difference, i.e. Projects! ? = µ R2 – µ R1 , and the corresponding similarity limits are those accepted in bioequivalence studies, i.e. (? L , ? U ) = (log0.8, log1.25) = (-0.223, 0.223). The data are assumed to following normal distribution, and the means and on wuthering heights variances of the two reference products are assumed to physics research projects be the same in the simulation, i.e. µ R1 = µ R2 = µ and s R1 = s R2 = s. To evaluate how reference standards are affected by variability of the drug products, different coefficients of variation are chosen: 20–50% by an increment of 5%. Essay On Wuthering Heights! Note that coefficients of variation is the ratio of the physics papers projects standard deviation to the mean, therefore in terms of s and µ in the normal distribution, the essay chosen coefficients of variation values translate to s = 0.2µ, 0.25µ, 0.3µ, 0.35µ, 0.4µ, 0.45µ or 0.5µ. In bioequivalence studies, it is recommended that data are first log-transformed. For lognormal distribution, coefficients of physics research projects variation of 20%, 25%, 30%, 35%, 40%, 45% and 50% translate to s = 0.2, 0.25, 0.294, 0.340, 0.385, 0.429 and devil tom walker question 0.472 ( ). We have chosen µ = 1 so that the results are comparable with those shown in original scales in bioequivalence studies. The effects of different sample sizes (n = n 1 + n 2 = 40, 50, 60, 70, 80, 90 and 100) with equal allocation are also investigated.
A total of physics projects 1,000 random trials are generated for each parameter combinations. The percentage of trials that have passed the Step 1 biosimilarity test, i.e. the probability of claiming biosimilarity on the basis of the average biosimilarity criterion, are shown in Table 2 and Figure 1. The results are in accordance with results observed in other studies . On Wuthering Heights! As the physics papers variability increases, the probability decreases. Even with no mean difference between the two drug products, the probability of concluding biosimilarity can be quite low when the coefficients of variation are high. For example, when the coefficients of variation is 50%, with a total sample size of 40, biosimilarity is concluded only short essay on adolescence about 30% of the times. The probability of physics projects concluding biosimilarity can be boosted by increasing sample size. In the previous scenario, the probability can be increased from 30% to 86% if a sample size of 100 is used instead of 40.
For those trials that have passed the Step 1 test, the p values from the Schuirmann’s two one-sided tests procedure are recorded and the averages are reported in tom walker Table 3 and Figure 2. As the variability increases, the p values also increase, becoming close to 0.05. Projects! In other words, as the variability increases, the tom walker evidence against null hypotheses weakens. For those trials that have passed the Step 1 test, we further report in Table 4 and Figure 3 the reproducibility probability or biosimilarity index, termed p RR in R–R study. The p RR is calculated from papers projects, equation (6). Tom Walker Essay! As expected, the results show that the papers p RR increases as the sample size increases, and it decreases as variability increases. Notice that when the coefficients of variation are 45%, and the total sample size is 40, the p RR is only 48.5%.
When a reference drug compared with itself can only have a 48.5% reproducibility probability, it is superfluous to follow the same study design to demonstrate that a ‘follow-on biologic’ is highly similar to this reference. There are two ways to correct a low p RR : one is to choose a different criterion as in short bioequivalence studies with the use of a scaled criterion; the other is to increase sample size. This also demonstrates the importance of conducting an R–R study: one is able to choose an appropriate criterion, sample size, or both, to establish reference standards. As shown above in physics research projects the simulation studies, as coefficients of variation increase, it is less likely that similarity can be declared even when R is compared with R. To further illustrate the effect of the on wuthering heights high variability on papers projects the conclusion of on adolescence biosimilarity, and how the physics papers biosimilarity index addresses the degree of similarity, we consider example data with a total sample size of 40 and coefficients of variation of 45%, again assuming no true mean difference. First, we obtain an example where H 0 is not rejected and phonemic script give the physics research projects sample means in Table 5. The observed mean difference and the observed variability . The 90% confidence interval of the mean difference is (-0.065, 0.327); similarity is not declared. Under the same setting, another set of research on bail data is generated. Under this scenario, we observe that R 1 and R 2 are not identical yet similarity is declared. Physics Research Papers Projects! The sample means are given in Table 6, from which we could calculate the sample mean difference and the variability . From the observed mean difference and variability, the p RR as evaluated from equation (6) is 0.563.
This example shows that when coefficients of variation is high, even though biosimilarity is declared based on phonemic script the average similarity criterion, the degree of similarity as measured by biosimilarity index is low, so is the confidence that we have in the biosimilarity conclusion. The simulation studies have shown that, as variance increases, the physics research projects probability of declaring biosimilarity in the Step 1 test decreases; and, for those trials that pass the Step 1 test, the degree of similarity, quantified by biosimilarity index, decreases. On Bail! The biosimilarity index is calculated for the trials that have passed the papers Step 1 test, thus it reflects the characteristics of the biological products that have already been declared biosimilar based on the average biosimilarity criterion. To apply the short biosimilar index approach, an appropriate p 0 , see Table 1 for details of projects Step 3 in the testing procedure, needs to be determined. Phonemic Script! We recommend p 0 = 0.7p RR or 0.8p RR, such that the comparison is physics research, relative to the reference products. If we define d = p 0 /p RR , then d can be used to address the devil essay question degree of similarity and the question of ‘how similar is highly similar?’ Thus, it is important to obtain reference standards because it establishes the baseline for testing biosimilar products.
In this paper, we show that an R-R study is conducted separately to obtain reference standards. Reference standards can also be established concurrently using the three-arm study as proposed by Kang and research papers projects Chow . In the on wuthering three-arm study, participants are randomly assigned to be treated with either test product (T) in one arm, or two different reference products (R 1 , R 2 ) in physics research the other two arms, such that reference standards are established concurrently in of exercise in our for students the two reference arms and used as baseline for the test product. The idea as outlined in research this paper can be applied to essay establish reference standards for biosimilarity index developed based on other criteria for the assessment of biosimilarity. For example, a biosimilarity index may be developed based on the concepts of population bioequivalence or individual bioequivalence.
Another important concept in biosimilarity studies is interchangeability. To assess interchangeability, it needs to physics research papers projects be shown that the risk, i.e. safety or diminished efficacy of alternating or switching between use of the biosimilar and the reference product, are not greater than the risk of using the reference product without such alternation or switch. Research On Bail! The same idea could be followed to establish reference standards to be used as the baseline for the assessment of interchangeability. This work was partially supported by National Institutes of Health grants P01 CA142538 to Associate Professor Jung-Ying Tzeng. Provenance and peer review: Not commissioned; externally peer reviewed. Associate Professor Jung-Ying Tzeng, Department of Statistics and Bioinformatics Research Center, North Carolina State University, Raleigh, NC 27607, USA. Professor Shein-Chung Chow, Professor of Biostatistics and Bioinformatics, Department of Bioinformatics and physics research Biostatistics, Duke University School of Medicine, Suite 1102, Hock Plaza, 2424 Erwin Road, Durham, NC 27705, USA. 1. U.S. Phonemic Script! Food and Drug Administration.
Draft guidance for industry. Scientific considerations in demonstrating biosimilarity to physics research projects a reference product [homepage on the Internet]. 2012 Feb [cited 2013 Jun 10]. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. 2. Tom Walker! Kang SH, Chow SC. Statistical assessment of biosimilarity based on relative distance between follow-on biologics. Stat Med. 2013;32(3):382-92. 3. Physics Papers Projects! Chow SC, Endreny L, Lachenbruch PA, Yang LY, Chi E. Scientific factors for assessing biosimilarity and research drug interchangeability of follow-on biologics. Biosimilars.
2011;1:13-26. 4. Physics! Chow SC, Ju C. Assessing biosimilarity and interchangeability of biosimilar products under the Biologics Price Competition and Innovation Act. Generics and Biosimilars Initiative Journal (GaBI Journal). 2013;2(1):20-5. doi:10.5639/gabij.2013.0201.004. 5. Hsieh TV, Chow SC, Yang LY, Chi E. The evaluation of biosimilarity index based on reproducibility probability for assessing follow-on biologics. Stat Med. 2013;32(3):406-13. 6. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm.
1987;15(6):657-80. 7. Shao J, Chow SC. Reproducibility probability in clinical trials. Stat Med. 2002; 21(12):1727-42. 8. Chow SC, Yang LY, Starr A, Chiu ST. Statistical methods for assessing interchangeability of biosimilars. Stat Med. 2013;32(3):442-8. 9. Chow SC, Liu PB.
Design and analysis of bioavailability and bioequivalence studies. 3rd ed. New York: Taylor and Francis; 2008. Author for on french the foundation, correspondence: Aijing Zhang, PhD, 5109 SAS Hall, 2311 Stinson Drive, Raleigh, NC 27695, USA. Disclosure of Conflict of Interest Statement is available upon request. Copyright © 2013 Pro Pharma Communications International. Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher.
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