Statistical issues in drug development

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Title:

Author:

Senn, Stephen, author.

ISBN:

9781119238614

9781119238607

9781119238591

Edition:

Third edition.

Physical Description:

1 online resource (xxi, 616 pages) : color illustrations.

Series:

Statistics in practice

Statistics in practice.

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.

Abstract:

"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"-- Provided by publisher

Local Note:

John Wiley and Sons

Subject Term:

Drugs -- Design -- Statistical methods.

Drugs -- Design.

Drug development -- Statistical methods.

Clinical Trials as Topic

Drug Design

Statistics as Topic -- methods

Médicaments -- Développement -- Méthodes statistiques.

Médicaments -- Conception -- Méthodes statistiques.

Médicaments -- Conception.