Focusing on the application of physical pharmacy, drug design, and drug regulations as they relate to produce effective dosage forms for drug delivery, Integrated Pharmaceutics provides a comprehensive picture of pharmaceutical product design, describing the science and art behi…
"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."
All current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and ISO 9000 standards and regulations require that validation document be established and followed. Yet these regulations do not provide guidelines on how to produce …
Annotation This book examines United States law and governmental policy affecting domestic and multinational pharmaceutical manufacturing, recommending pragmatic ways to interpret and comply with FDA current good manufacturing practice (CGMP) regulation and related criteria.
