Process Chemistry in the Pharmaceutical Industry, Volume 2: Challenges in an Ever Changing Climate

Defying the misconception of process chemistry as mere scale-up work, this volume explores the most up-to-date process research and development methods applied to synthesis, clinical trials, and commercial drug candidates. It discusses new approaches to synthetic processes, examines the latest safety methods and design experiments, and suggests realistic solutions to problems encountered in manufacturing and process development. Topics include new synthesis methods, instrumentation, automation, quality control, cost considerations, regulatory issues, outsourcing, green practices, and future trends. Case studies demonstrate strategies for aggressive drug development programs.