- Planning and Analyzing Clinical Trials with Composite Endpoints68,99 €
- Planning and Analyzing Clinical Trials with Composite Endpoints95,99 €
- The Challenge of CMC Regulatory Compliance for Biopharmaceuticals127,99 €
- Epidemiology111,99 €
- Epidemiology51,99 €
- Rank and Pseudo-Rank Procedures for Independent Observations in Factorial Designs84,99 €
- The Statistical Analysis of Recurrent Events111,99 €
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.
- Springer Series in Pharmaceutical Statistics
- Verlag: Springer / Springer, Berlin
- Artikelnr. des Verlages: 978-3-319-83434-4
- Softcover reprint of the original 1st ed. 2017
- Seitenzahl: 264
- Erscheinungstermin: 28. Juli 2018
- Abmessung: 235mm x 155mm x 14mm
- Gewicht: 409g
- ISBN-13: 9783319834344
- ISBN-10: 3319834347
- Artikelnr.: 53578452
A Frequentist Decision
Characteristics of a Diagnostic Test.
The Parallel Between Clinical Trials and Diagnostic Tests.
Incorporating Information from Completed Trials in Future Trial Planning.
Choosing Metrics Appropriate for Different Stages of Drug Development.
Concept Trials with Desired Characteristics.
response Studies with Desired Characteristics.
Designing Confirmatory Trials with Desired Characteristics.
Designing Phase 4 Trials.
Other Metrics That Have Been Proposed to Optimize Drug Development Decisions.
Discounting Prior Results to Account for Selection Bias.
"It is presented in a concise, structured, friendly, and illustrative way that allows for a good understanding of the underlying ideas ... . the book from Chuang-Stein and Kirby is a valuable, interesting and easy read for statisticians and clinicians with some methodological background who are involved in clinical development or drug approval and who are looking for a structured way to make clinical development decisions." (Norbert Benda, Biometrical Journal, Vol. 61 (4), July, 2016)