Quantitative Decisions in Drug Development

Released on by Christy Chuang-Stein
preview-18

  • Quantitative Decisions in Drug Development Book Detail

  • Author : Christy Chuang-Stein
  • Release Date : 2021-09-03
  • Publisher : Springer Nature
  • Genre : Mathematics
  • Pages : 354
  • ISBN 13 : 3030797317
  • File Size : 1,1 MB
DOWNLOAD BOOK

Quantitative Decisions in Drug Development by Christy Chuang-Stein PDF Summary

Book Description: This book focuses on important decision points and evidence needed for making decisions at these points during the development of a new drug. It takes a holistic approach towards drug development by incorporating explicitly knowledge learned from the earlier part of the development and available historical information into decisions at later stages. In addition, the book shares lessons learned from several select examples published in the literature since the publication of the first edition. The second edition reiterates the need for making evidence-based Go/No Go decisions in drug development discussed in the first edition. It substantially expands several topics that have seen great advances since the publication of the first edition. The most noticeable additions include three adaptive trials conducted in recent years that offer excellent learning opportunities, the use of historical data in the design and analysis of clinical trials, and extending decision criteria to the cases when the primary endpoint is binary. The examples used to illustrate the additional materials all come from real trials with some post-trial reflections offered by the authors. 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. Prior knowledge includes information pertaining to historical controls. To assist decision making, the book discusses appropriate metrics and the formulation of go/no-go decisions for progressing a drug candidate to the next development stage. Using the concept of the positive predictive value in the field of diagnostics, the book leads readers to the assessment of the probability that an investigational product is effective given positive study outcomes. Lastly, the book 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.

Disclaimer: www.yourbookbest.com does not own Quantitative Decisions in Drug Development books pdf, neither created or scanned. We just provide the link that is already available on the internet, public domain and in Google Drive. If any way it violates the law or has any issues, then kindly mail us via contact us page to request the removal of the link.

Quantitative Decisions in Drug Development

Quantitative Decisions in Drug Development

File Size : 37,37 MB
Total View : 6016 Views
DOWNLOAD

This book focuses on important decision points and evidence needed for making decisions at these points during the development of a new drug. It takes a holisti

Quantitative Decisions in Drug Development

Quantitative Decisions in Drug Development

File Size : 31,31 MB
Total View : 7383 Views
DOWNLOAD

This book focuses on important decision points and evidence needed for making decisions at these points during the development of a new drug. It takes a holisti

Clinical Trial Simulations

Clinical Trial Simulations

File Size : 25,25 MB
Total View : 5085 Views
DOWNLOAD

This edition includes both updates and new uses and issues concerning CTS, along with case studies of how clinical trial simulations are being applied in variou

Pharmacometrics

Pharmacometrics

File Size : 19,19 MB
Total View : 9182 Views
DOWNLOAD

Pharmacometrics is the science of interpreting and describing pharmacology in a quantitative fashion. The pharmaceutical industry is integrating pharmacometrics