Quantitative Decisions in Drug Development (Paperback, Softcover reprint of the original 1st ed. 2017)

This book offers a high-level treatise of evidence-based decisions in drug development. Because of the inseparable relationship between designs and decisions, a good portion of this book is devoted to the design of clinical trials. The book begins with an overview of product development and regulatory approval pathways. It then discusses how to incorporate prior knowledge into study design and decision making at different stages of drug development. The latter include selecting appropriate metrics to formulate decisions criteria, determining go/no-go decisions for progressing a drug candidate to the next stage and predicting the effectiveness of a product. Lastly, it points out common mistakes made by drug developers under the current drug-development paradigm. The book offers useful insights to statisticians, clinicians, regulatory affairs managers and decision-makers in the pharmaceutical industry who have a basic understanding of the drug-development process and the clinical trials conducted to support drug-marketing authorization. The authors provide software codes for select analytical approaches discussed in the book. The book includes enough technical details to allow statisticians to replicate the quantitative illustrations so that they can generate information to facilitate decision-making themselves.

General

Imprint:	Springer International Publishing AG
Country of origin:	Switzerland
Series:	Springer Series in Pharmaceutical Statistics
Release date:	July 2018
First published:	2017
Authors:	Christy Chuang-Stein • Simon Kirby
Dimensions:	235 x 155 x 14mm (L x W x T)
Format:	Paperback
Pages:	248
Edition:	Softcover reprint of the original 1st ed. 2017
ISBN-13:	978-3-319-83434-4
Categories:	Books > Science & Mathematics > Mathematics > Probability & statistics Books > Medicine > Other branches of medicine > Pharmacology > General Books > Science & Mathematics > Biology, life sciences > Life sciences: general issues > General Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology Books > Professional & Technical > Mechanical engineering & materials > Production engineering > Reliability engineering
LSN:	3-319-83434-7
Barcode:	9783319834344

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