Tested and proven solutions to the challenges of biological drug product development
Biological drug products play a central role in combating human diseases; however, developing new successful biological drugs presents many challenges, including labor intensive production processes, tighter regulatory controls, and increased market competition. This book reviews the current state of the science, offering readers a single resource that sets forth the fundamentals as well as tested and proven development strategies for biological drugs. Moreover, the book prepares readers for the challenges that typically arise during drug development, offering straightforward solutions to improve their ability to pass through all the regulatory hurdles and deliver new drug products to the market.
Biological Drug Products begins with general considerations for the development of any biological drug product and then explores the strategies and challenges involved in the development of specific types of biologics. Divided into five parts, the book examines:
- Part 1: General Aspects
- Part 2: Proteins and Peptides
- Part 3: Vaccines
- Part 4: Novel Biologics
- Part 5: Product Administration/Delivery
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发表于 2014-8-4 00:29:17
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