Ditemukan 4 dokumen yang sesuai dengan query
Hemberg-stahl, Elizabert
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Abstract:
This authoritative and comprehensive book makes the reader familiar with the processes of bringing orphan drugs to the global market. There are between 5,000 and 7,000 rare diseases and the number of patients suffering from them is estimated to be more than 50 million in the US and Europe ...
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Cambridge, UK: Biohealthcare Pub, 2012
615.19 HEM o
Buku Teks 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
Abood, Richard R.
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Contents :
The law and the legal system -- Federal regulation of medications : development, production, and marketing -- Federal regulation of medications : dispensing -- The closed system of controlled substance distribution -- Dispensing controlled substances -- Federal regulation of pharmacy practice -- State regulation of pharmacy practice -- Pharmacist malpractice liability and risk management strategies ...
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Burlington, MA: Jones and Bartlett Learning, 2014
344.7 ABO p (1)
Buku Teks Universitas Indonesia Library
Feinberg, Debra B.
New York : McGraw-Hill, 2008
344.730 4 FEI p
Buku Teks Universitas Indonesia Library
