Quantitative Decisions in Drug Development

Nonfiction, Health & Well Being, Medical, Reference, Biostatistics, Science & Nature, Mathematics, Science, Biological Sciences
Cover of the book Quantitative Decisions in Drug Development by Christy Chuang-Stein, Simon Kirby, Springer International Publishing
View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart
Author: Christy Chuang-Stein, Simon Kirby ISBN: 9783319460765
Publisher: Springer International Publishing Publication: May 25, 2017
Imprint: Springer Language: English
Author: Christy Chuang-Stein, Simon Kirby
ISBN: 9783319460765
Publisher: Springer International Publishing
Publication: May 25, 2017
Imprint: Springer
Language: English

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.

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

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.

More books from Springer International Publishing

Cover of the book Silicon and Plant Diseases by Christy Chuang-Stein, Simon Kirby
Cover of the book Peri-Urban Developments and Processes in Africa with Special Reference to Zimbabwe by Christy Chuang-Stein, Simon Kirby
Cover of the book The Influence of Chemistry on New Foods and Traditional Products by Christy Chuang-Stein, Simon Kirby
Cover of the book Reducing Inequalities by Christy Chuang-Stein, Simon Kirby
Cover of the book Multilayer Control of Networked Cyber-Physical Systems by Christy Chuang-Stein, Simon Kirby
Cover of the book Advances in QSAR Modeling by Christy Chuang-Stein, Simon Kirby
Cover of the book The Creation of Local Innovation Systems in Emerging Countries by Christy Chuang-Stein, Simon Kirby
Cover of the book Service Quality in Indian Hospitals by Christy Chuang-Stein, Simon Kirby
Cover of the book Electronic Participation by Christy Chuang-Stein, Simon Kirby
Cover of the book Computer Vision – ACCV 2018 by Christy Chuang-Stein, Simon Kirby
Cover of the book After-School Programs to Promote Positive Youth Development by Christy Chuang-Stein, Simon Kirby
Cover of the book The British in Argentina by Christy Chuang-Stein, Simon Kirby
Cover of the book Indebtedness in Early Adulthood by Christy Chuang-Stein, Simon Kirby
Cover of the book Astronomy for Older Eyes by Christy Chuang-Stein, Simon Kirby
Cover of the book Teaching Gender and Sex in Contemporary America by Christy Chuang-Stein, Simon Kirby
We use our own "cookies" and third party cookies to improve services and to see statistical information. By using this website, you agree to our Privacy Policy