Ditemukan 2 dokumen yang sesuai dengan query
Guidebook for drug regulatory submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development.
Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation,...
Hoboken, New Jersey: John Wiley & Sons, 2009
e20393944
eBooks Universitas Indonesia Library
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
