Statistical thinking for non-statisticians in drug regulation:
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Chichester, West Sussex, UK
Wiley Blackwell
2015
|
| Ausgabe: | Second edition |
| Schlagworte: | |
| Online-Zugang: | FRO01 UBG01 Volltext |
| Beschreibung: | Includes bibliographical references and index Statistical Thinking for Non-Statisticians in Drug Regulation, Second Edition, is a need-to-know guide to understanding statistical methodology, statistical data and results within drug development and clinical trials.It provides non-statisticians working in the pharmaceutical and medical device industries with an accessible introduction to the knowledge they need when working with statistical information and communicating with statisticians. It covers the statistical aspects of design, conduct, analysis and presentation of data from clinical trials in drug regulation and improves the ability to read, understand and critically appraise statistical methodology in papers and reports. As such, it is directly concerned with the day-to-day practice and the regulatory requirements of drug development and clinical trials.Fully conversant with current regulatory requirements, this second edition includes five new chapters covering Bayesian statistics, adaptive designs, observational studies, methods for safety analysis and monitoring and statistics for diagnosis.Authored by a respected lecturer and consultant to the pharmaceutical industry, Statistical Thinking for Non-Statisticians in Drug Regulation is an ideal guide for physicians, clinical research scientists, managers and associates, data managers, medical writers, regulatory personnel and for all non-statisticians working and learning within the pharmaceutical industry |
| Beschreibung: | 1 Online-Ressource |
| ISBN: | 9781118470978 1118470974 9781118470992 1118470990 9781118470961 1118470966 |
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| 245 | 1 | 0 | |a Statistical thinking for non-statisticians in drug regulation |c Richard Kay, PhD, Statistical Consultant, RK Statistics Ltd, Honorary Visiting Professor, School of Pharmacy, Cardiff University, UK. |
| 250 | |a Second edition | ||
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| 650 | 4 | |a Clinical Trials as Topic / methods | |
| 650 | 4 | |a Drug Approval | |
| 650 | 4 | |a Drug Industry | |
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| 650 | 4 | |a Drugs / Testing / Statistical methods | |
| 650 | 4 | |a Drug approval / Statistical methods | |
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| dewey-full | 615.5/80724 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615.5/80724 |
| dewey-search | 615.5/80724 |
| dewey-sort | 3615.5 580724 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| edition | Second edition |
| format | Electronic eBook |
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| spelling | Kay, R. Verfasser aut Statistical thinking for non-statisticians in drug regulation Richard Kay, PhD, Statistical Consultant, RK Statistics Ltd, Honorary Visiting Professor, School of Pharmacy, Cardiff University, UK. Second edition Chichester, West Sussex, UK Wiley Blackwell 2015 1 Online-Ressource txt rdacontent c rdamedia cr rdacarrier Includes bibliographical references and index Statistical Thinking for Non-Statisticians in Drug Regulation, Second Edition, is a need-to-know guide to understanding statistical methodology, statistical data and results within drug development and clinical trials.It provides non-statisticians working in the pharmaceutical and medical device industries with an accessible introduction to the knowledge they need when working with statistical information and communicating with statisticians. It covers the statistical aspects of design, conduct, analysis and presentation of data from clinical trials in drug regulation and improves the ability to read, understand and critically appraise statistical methodology in papers and reports. As such, it is directly concerned with the day-to-day practice and the regulatory requirements of drug development and clinical trials.Fully conversant with current regulatory requirements, this second edition includes five new chapters covering Bayesian statistics, adaptive designs, observational studies, methods for safety analysis and monitoring and statistics for diagnosis.Authored by a respected lecturer and consultant to the pharmaceutical industry, Statistical Thinking for Non-Statisticians in Drug Regulation is an ideal guide for physicians, clinical research scientists, managers and associates, data managers, medical writers, regulatory personnel and for all non-statisticians working and learning within the pharmaceutical industry Clinical Trials as Topic / methods Drug Approval Drug Industry Statistics as Topic MEDICAL / Pharmacology bisacsh Medical Medizin Clinical trials / Statistical methods Drugs / Testing / Statistical methods Drug approval / Statistical methods Pharmaceutical industry / Statistical methods Electronic books Erscheint auch als Druck-Ausgabe, Hardcover 978-1-118-47094-7 https://onlinelibrary.wiley.com/doi/book/10.1002/9781118470961 Verlag URL des Erstveröffentlichers Volltext |
| spellingShingle | Kay, R. Statistical thinking for non-statisticians in drug regulation Clinical Trials as Topic / methods Drug Approval Drug Industry Statistics as Topic MEDICAL / Pharmacology bisacsh Medical Medizin Clinical trials / Statistical methods Drugs / Testing / Statistical methods Drug approval / Statistical methods Pharmaceutical industry / Statistical methods |
| title | Statistical thinking for non-statisticians in drug regulation |
| title_auth | Statistical thinking for non-statisticians in drug regulation |
| title_exact_search | Statistical thinking for non-statisticians in drug regulation |
| title_full | Statistical thinking for non-statisticians in drug regulation Richard Kay, PhD, Statistical Consultant, RK Statistics Ltd, Honorary Visiting Professor, School of Pharmacy, Cardiff University, UK. |
| title_fullStr | Statistical thinking for non-statisticians in drug regulation Richard Kay, PhD, Statistical Consultant, RK Statistics Ltd, Honorary Visiting Professor, School of Pharmacy, Cardiff University, UK. |
| title_full_unstemmed | Statistical thinking for non-statisticians in drug regulation Richard Kay, PhD, Statistical Consultant, RK Statistics Ltd, Honorary Visiting Professor, School of Pharmacy, Cardiff University, UK. |
| title_short | Statistical thinking for non-statisticians in drug regulation |
| title_sort | statistical thinking for non statisticians in drug regulation |
| topic | Clinical Trials as Topic / methods Drug Approval Drug Industry Statistics as Topic MEDICAL / Pharmacology bisacsh Medical Medizin Clinical trials / Statistical methods Drugs / Testing / Statistical methods Drug approval / Statistical methods Pharmaceutical industry / Statistical methods |
| topic_facet | Clinical Trials as Topic / methods Drug Approval Drug Industry Statistics as Topic MEDICAL / Pharmacology Medical Medizin Clinical trials / Statistical methods Drugs / Testing / Statistical methods Drug approval / Statistical methods Pharmaceutical industry / Statistical methods |
| url | https://onlinelibrary.wiley.com/doi/book/10.1002/9781118470961 |
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