Expediting Drug & Biologics Development: A Strategic Approach 2021
From the initial planning to the NDA/BLA review process, Expediting Drug and Biologics Development shows you how to use reverse-engineering techniques to drive and improve each aspect of a drug and biologic product development program’s design and implementation. Written by dozens of leading experts, this book is a real-world “doer’s” guide. It provides templates, forms, and tools to assist those “in the trenches” of new drug and biologic development today.
With this book, you will learn how to:
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Make planning the central part of all aspects of drug and biologics development.
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Establish a Target Product Profile (TPP) to critically evaluate the needs of the evolving package insert and eventual marketing application before getting deeply into clinical trials.
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Understand that the clinical development program dictates much of the nonclinical development program, and that both dictate the chemistry, manufacturing and controls development program.
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Involve thoughtful ethics in the planning and execution of clinical research.
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Leverage standardization to drive and expedite the entire development process, from the development of clinical trial protocols to the development of clinical data presentations.
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Critically assess the needs of a final study report before developing the clinical protocol.
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Use the data identified in the analysis plan and gathered by various data collection tools to dictate the content of the procedures section of the clinical protocol.
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The role of monitoring as one part of a multi-faceted approach to evaluating safety in a clinical trial.
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Anticipate the demands of the regulatory authority review process, the audits that will support data integrity, and the mechanics of Advisory Committee reviews.
September 2021, 654 pp., ISBN# 978-0-9963462-9-0, $195.00
Edited by Steven E. Linberg, Ph.D., and Janice M. Soreth, M.D.
