ENGLISH

New Drug Development: Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics

By Chandrahas Sahajwalla

Book information

Publisher
Informa Healthcare
Year
2004
ISBN
9780824754655, 0824754654
Open Library ID
OL22597286M
Language
english
Format
ZIP
Filesize
5 MB (4915752 bytes)
Series
Drugs and the Pharmaceutical Sciences
Edition
1
Pages
500\27
Library
mexmat
Time added
2009-11-09 02:42:13

Description

Highlighting key points from the latest regulatory requirements, this book helps those new to the world of pharmaceutical development understand regulatory steps, reduce cost by avoiding unnecessary trials, and attain guidance through each step of the drug approval process. This volume acquaints readers with procedures that determine the success of drug development projects with updated regulatory guidelines from the FDA and ICH, solutions to hurdles in application protocols, and recommendations from more than forty respected and experience officials from regulatory agencies around the globe. It covers topics related to the development of chiral drugs, liposomal products, and more.

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