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Statistical Thinking for Non-Statisticians in Drug Regulation by Richard Kay (Consultant in Statistics for the Pharmaceutical Industry, Great Longstone, Derbyshire, UK) at Abbey's Bookshop,
Statistical Thinking for Non-Statisticians in Drug Regulation
— —
Richard Kay (Consultant in Statistics for the Pharmaceutical Industry, Great Longstone, Derbyshire, UK)

Statistical Thinking for Non-Statisticians in Drug Regulation

Richard Kay (Consultant in Statistics for the Pharmaceutical Industry, Great Longstone, Derbyshire, UK)

$138.95

Hardback

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English
Wiley-Blackwell
23 March 2023
Other branches of medicine
STATISTICAL THINKING FOR NON-STATISTICIANS IN DRUG REGULATION

Statistical methods in the pharmaceutical industry are accepted as a key element in the design and analysis of clinical studies. Increasingly, the medical and scientific community are aligning with the regulatory authorities and recognizing that correct statistical methodology is essential as the basis for valid conclusions. In order for those correct and robust methods to be successfully employed there needs to be effective communication across disciplines at all stages of the planning, conducting, analyzing and reporting of clinical studies associated with the development and evaluation of new drugs and devices.

Statistical Thinking for Non-Statisticians in Drug Regulation provides a comprehensive in-depth guide to statistical methodology for pharmaceutical industry professionals, including physicians, investigators, medical science liaisons, clinical research scientists, medical writers, regulatory personnel, statistical programmers, senior data managers and those working in pharmacovigilance. The author’s years of experience and up-to-date familiarity with pharmaceutical regulations and statistical practice within the wider clinical community make this an essential guide for the those working in and with the industry.

The third edition of Statistical Thinking for Non-Statisticians in Drug Regulation includes:

A detailed new chapter on Estimands in line with the 2019 Addendum to ICH E9 Major new sections on topics including Combining Hierarchical Testing and Alpha Adjustment, Biosimilars, Restricted Mean Survival Time, Composite Endpoints and Cumulative Incidence Functions, Adjusting for Cross-Over in Oncology, Inverse Propensity Score Weighting, and Network Meta-Analysis Updated coverage of many existing topics to reflect new and revised guidance from regulatory authorities and author experience

Statistical Thinking for Non-Statisticians in Drug Regulation is a valuable guide for pharmaceutical and medical device industry professionals, as well as statisticians joining the pharmaceutical industry and students and teachers of drug development.
By:  
Imprint:   Wiley-Blackwell
Country of Publication:   United States
Edition:   3rd edition
Dimensions:   Height: 245mm,  Width: 178mm,  Spine: 29mm
Weight:   879g
ISBN:   9781119867388
ISBN 10:   111986738X
Pages:   432
Publication Date:  
Audience:   Professional and scholarly ,  Undergraduate
Format:   Hardback
Publisher's Status:   Active

Richard Kay, PhD is a Visiting Professor at the School of Pharmacy and Pharmaceutical Medicine, Cardiff University, UK, and a longtime statistical consultant for the pharmaceutical industry. He provides consultancy and training services for pharmaceutical companies and research institutions.

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