The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

ISBN: 9780306480409

出版年: 2003-12

页数: 373

定价: $ 292.67

内容简介

This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval.