Ditemukan 7 dokumen yang sesuai dengan query
Erni Hernawati Purwaningsih
Jakarta: UI-Press, 2013
PGB 0282
UI - Pidato Universitas Indonesia Library
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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, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines.
As well, vital information is provided on the most common types ...
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Hoboken, New Jersey: John Wiley & Sons, 2009
e20393944
eBooks Universitas Indonesia Library
Ng, Rick
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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 -- Future perspectives ...
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Hoboken, NJ: Wiley-Blackwell, 2009
615.19 RIC d
Buku Teks Universitas Indonesia Library
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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 appendix, and one or two carefully selected "mini" case studies in each chapter.
This second edition has been completely revised to include the latest advances ...
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Hoboken: John Wiley & Sons, 2009
e20393904
eBooks Universitas Indonesia Library
Brody, Tom
Amsterdam: Elsevier/Academic Press, 2012
615.507 24 BRO c
Buku Teks Universitas Indonesia Library
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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 combination drug product to market, it also sets forth the most efficient and effective path to FDA approval. The book begins with an introductory chapter ...
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Hoboken, New Jersey: John Wiley & Sons, 2008
e20385305
eBooks Universitas Indonesia Library
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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 preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research ...
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Hoboken: John Wiley & Sons, 2010
e20393907
eBooks Universitas Indonesia Library
