Ditemukan 12 dokumen yang sesuai dengan query
A step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufacturing stages. Written from an FDA regulatory perspective, the book not only enables you to bring a successful...
Hoboken, New Jersey: John Wiley & Sons, 2008
e20385305
eBooks Universitas Indonesia Library
Weinberg, Sandy, author
This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance...
Hoboken: John Wiley & Sons, 2011
e20377190
eBooks Universitas Indonesia Library
