Bayesian Applications in Pharmaceutical Development

ISBN-13: 9781032177021 / Angielski / Miękka / 2021 / 532 str.

Mani Lakshminarayanan; Fanni Natanegara

Opis

This provides comprehensive coverage of Bayesian application across the span of drug development from discovery to clinical trial to manufacturing with practical examples as illustration.

Spis treści

Introduction. Building prior. Discover/preclinical phase. Clinical phase. Product development. Regulatory overview of Bayesian application. Computational tools. Special topics.

O autorze

Dr. Mani Lakshminarayanan is a researcher and statistical consultant with more than 30 years of experience in the pharmaceutical industry. He has published over 50 articles, technical reports, and book chapters besides serving as a referee for several journals.　He has a Ph.D. in Statistics from Southern Methodist University, Dallas, Texas and is a Fellow of the American Statistical Association.

Dr. Fanni Natanegara has over 15 years of pharmaceutical experience and is currently Principal Research Scientist and Group Leader for the Early Phase Neuroscience Statistics team at Eli Lilly and Company. She played a key role in the Advanced Analytics team to provide Bayesian education and statistical consultation at Eli Lilly. Dr. Natanegara is the chair of the cross industry-regulatory-academic DIA BSWG to ensure that Bayesian methods are appropriately utilized for design and analysis throughout the drug-development process.