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Statistical 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...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Chichester, England ; Hoboken, NJ :
John Wiley & Sons,
©2007.
|
| Edición: | 2nd ed. |
| Colección: | Statistics in practice.
|
| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 100 | 1 | |a Senn, Stephen. | |
| 245 | 1 | 0 | |a Statistical issues in drug development / |c Stephen Senn. |
| 250 | |a 2nd ed. | ||
| 260 | |a Chichester, England ; |a Hoboken, NJ : |b John Wiley & Sons, |c ©2007. | ||
| 300 | |a 1 online resource (xix, 498 pages) : |b illustrations | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 347 | |a data file | ||
| 490 | 1 | |a Statistics in practice | |
| 504 | |a Includes bibliographical references and index. | ||
| 505 | 0 | |a 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. | |
| 505 | 0 | |a 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. | |
| 505 | 0 | |a 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. | |
| 588 | 0 | |a Print version record. | |
| 520 | |a 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. | ||
| 590 | |a ProQuest Ebook Central |b Ebook Central Academic Complete | ||
| 650 | 0 | |a Drug development |x Statistical methods. | |
| 650 | 0 | |a Drugs |x Design. | |
| 650 | 2 | |a Clinical Trials as Topic | |
| 650 | 2 | |a Drug Design | |
| 650 | 2 | |a Statistics as Topic |x methods | |
| 650 | 6 | |a Médicaments |x Développement |x Méthodes statistiques. | |
| 650 | 6 | |a Médicaments |x Conception. | |
| 650 | 7 | |a MEDICAL |x Drug Guides. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Pharmacology. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Pharmacy. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Nursing |x Pharmacology. |2 bisacsh | |
| 650 | 7 | |a Drugs |x Design |2 fast | |
| 650 | 7 | |a Drug development |x Statistical methods |2 fast | |
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| 650 | 1 | 7 | |a Geneesmiddelen. |2 gtt |0 (NL-LeOCL)078516625 |
| 650 | 1 | 7 | |a Research and Development. |2 gtt |0 (NL-LeOCL)078649544 |
| 758 | |i has work: |a Statistical issues in drug development (Text) |1 https://id.oclc.org/worldcat/entity/E39PCGPD94rKvFGY7CXGxT8Jym |4 https://id.oclc.org/worldcat/ontology/hasWork | ||
| 776 | 0 | 8 | |i Print version: |a Senn, Stephen. |t Statistical issues in drug development. |b 2nd ed. |d Chichester, England ; Hoboken, NJ : John Wiley & Sons, ©2007 |w (DLC) 2007045553 |
| 830 | 0 | |a Statistics in practice. | |
| 856 | 4 | 0 | |u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=351458 |z Texto completo |
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