Name: Quantitative Decisions in Drug Development (en Inglés)
Price: 1561.49 MXN
Availability: InStock
Author: Chuang-Stein, Christy ; Kirby, Simon
ISBN: 9783319834344

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portada Quantitative Decisions in Drug Development (en Inglés)

Formato

Libro Físico

Autor

Christy Chuang-Stein

Simon Kirby

Editorial

Springer

Idioma

Inglés

N° páginas

248

Encuadernación

Tapa Blanda

Dimensiones

23.4 x 15.6 x 1.4 cm

Peso

0.38 kg.

ISBN13

9783319834344

N° edición

Categorías

Investigación médica
Epidemiología y estadística médica
Farmacia y prescripción
Biología

Quantitative Decisions in Drug Development (en Inglés)

Christy Chuang-Stein (Autor) · Simon Kirby (Autor) · Springer · Tapa Blanda

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Reseña del libro "Quantitative Decisions in Drug Development (en Inglés)"

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.