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portada Quantitative Decisions in Drug Development
Type
Physical Book
Author
Publisher
Language
English
Pages
248
Format
Paperback
Dimensions
23.4x15.6x1.4 cm
Weight
0.38 kg.
ISBN13
9783319834344
Edition No.
1
Categories

Quantitative Decisions in Drug Development

Christy Chuang-Stein (Author) · Simon Kirby (Author) · Springer · Paperback

Quantitative Decisions in Drug Development - Chuang-Stein, Christy ; Kirby, Simon

New Book Imported to Netherlands
Delivery: 17 Sep - 21 Sep Shipping: 5 to 6 business days.
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Synopsis "Quantitative Decisions in Drug Development"

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.

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