Téléchargez le livre : Quantitative Decisions in Drug Development
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Description

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 processand 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.
Pages
248 pages
Collection
Springer Series in Pharmaceutical Statistics
Parution
2017-05-25
Marque
Springer
EAN papier
9783319460758
EAN PDF
9783319460765
Informations sur l'ebook
Nombre pages copiables
2
Nombre pages imprimables
24
Taille du fichier
3226 Ko
Ce livre est accessible aux handicaps Voir les informations sur l'accessibilité
Prix
68,56 €
EAN EPUB
9783319460765
Informations sur l'ebook
Nombre pages copiables
2
Nombre pages imprimables
24
Taille du fichier
983 Ko
Ce livre est accessible aux handicaps Voir les informations sur l'accessibilité
Prix
68,56 €

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