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Statistical issues in drug development /

"This will be the third edition of Statistical Issues in Drug Development, and will be fully revised and updated to include information on the latest industry standards and guidelines. Both the first (1997) and second (2007) editions were very well received and the book has become a standard. T...

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Bibliographic Details
Main Authors: Senn, Stephen.
Corporate Authors: Wiley Online Library (Online service)
Published: John Wiley and Sons, Ltd.,
Publisher Address: Hoboken, NJ, USA :
Publication Dates: 2021.
Literature type: eBook
Language: English
Edition: Third edition.
Series: Statistics in practice
Subjects:
Clinical Trials as Topic.
Drug Design.
Statistics as Topic > methods.
Electronic books.
Online Access: https://onlinelibrary.wiley.com/doi/book/10.1002/9781119238614
Summary: "This will be the third edition of Statistical Issues in Drug Development, and will be fully revised and updated to include information on the latest industry standards and guidelines. Both the first (1997) and second (2007) editions were very well received and the book has become a standard. This book is unique in providing a thorough and critical discussion of the most important and controversial issues encountered by statisticians and their life scientist colleagues on both sides of the regulatory divide in drug development. The primary purpose of the book is to encourage and facilitate discussion between statisticians and their colleagues of the many complex statistical issues that arise in drug development. The book will be suitable as a course of self-instruction for statisticians who are new to the pharmaceutical industry, either because of recent graduation or change of career. It will also act as an authoritative reference for those working in drug development, and provide possible topics for discussion in journal forums"--
Item Description: Description based on print version record.
Carrier Form: 1 online resource (640 pages).
Also available in print.
Bibliography: Includes bibliographical references and index.
ISBN: 9781119238614 (electronic book)
9781119238577
Index Number: RM301
CLC: R914-32
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 Trial -- 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.

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