Ditemukan 7 dokumen yang sesuai dengan query
Erni Hernawati Purwaningsih, author
Jakarta: UI-Press, 2013
PGB 0282
UI - Pidato Universitas Indonesia Library
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
The book introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. This second edition features many key enhancements, including Key Points, Chapter Summary, and Review Questions in each chapter, Answers to Review Questions provided in a book-end...
Hoboken: John Wiley & Sons, 2009
e20393904
eBooks Universitas Indonesia Library
Ng, Rick, author
Contents :
Drug discovery : targets and receptors -- Drug discovery : small molecule drugs -- Drug discovery : large molecule drugs -- Drug development and preclinical studies -- Clinical trial -- Regulatory authorities -- Regulatory applications -- Good manufacturing practice : regulatory requirements -- Good manufacturing practice : drug manufacturing...
Hoboken, NJ: Wiley-Blackwell, 2009
615.19 RIC d
Buku Teks SO Universitas Indonesia Library
Brody, Tom, author
Amsterdam: Elsevier/Academic Press, 2012
615.507 24 BRO c
Buku Teks 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
The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early drug development : strategies and routes to first-in-human trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of...
Hoboken: John Wiley & Sons, 2010
e20393907
eBooks Universitas Indonesia Library
