This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.Optimizing interactions with FDA medical officers. ... SUPAC and Regulatory Consequences: The Balancing Act. FDA PUBLICATIONS Center for Biologies Evaluation ... Manual of Standard Operating Procedures and Policies, SOPP 8001.2.
|Title||:||Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics|
|Publisher||:||CRC Press - 2003-12-09|