Screen LibraryStatistical issues in drug development
Drug development is the process of finding and producing therapeutically useful pharmaceuticals, turning them into safe and effective medicine, and producing reliable information regarding the appropriate dosage and dosing intervals. With regulatory authorities demanding increasingly higher standard...
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| Main Authors: | |
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| Published: |
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| Literature type: | Electronic eBook |
| Language: | English |
| Edition: | 2nd ed. |
| Series: |
Statistics in practice
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| Subjects: | |
| Online Access: |
http://onlinelibrary.wiley.com/book/10.1002/9780470723586 |
| Summary: |
Drug development is the process of finding and producing therapeutically useful pharmaceuticals, turning them into safe and effective medicine, and producing reliable information regarding the appropriate dosage and dosing intervals. With regulatory authorities demanding increasingly higher standards in such developments, statistics has become an intrinsic and critical element in the design and conduct of drug development programmes. Statistical Issues in Drug Development presents an essential and thought provoking guide to the statistical issues and controversies involved in drug development. |
| Carrier Form: | 1 online resource (xix, 498 p.) : ill. |
| Bibliography: | Includes bibliographical references and index. |
| ISBN: |
9780470723579 (electronic bk.) 0470723572 (electronic bk.) 9780470723586 0470723580 |
| Index Number: | RM301 |
| CLC: | TQ46-37 |
| Contents: |
A brief and superficial history of statistics for drug developers -- Design and interpretation of clinical trials as seen by a statistician -- Probability, Bayes, P-values, tests of hypotheses, and confidence intervals -- The work of the pharmaceutical statistician -- Allocating treatments to patients in clinical trials -- Baselines and covariate information. The measurement of treatment effects -- Demographic subgroups : representation and analysis -- Multiplicity -- Intention to treat, missing data and related matters -- One-sided and two-sided tests and other issues to do with significance and P-values -- Determining the sample size -- Multicentre trials -- Active control equivalence studies. Meta-analysis -- Cross-over trials -- n-of-1 trials -- Sequential trials -- Dose-finding -- Concerning pharmacokinetics and pharmacodynamics -- Bioequivalence studies -- Safety data, harms, drug monitoring, and pharmaco-epidemiology -- Pharmaco-economics and portfolio management -- Concerning pharmacogenetics, pharmacogenomics, and related matters. |