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Bioavailability and Bioequivalence: An FDA Regulatory Overview |
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| Authors: | Chen Mei-Ling Shah Vinod Patnaik Rabindra Adams Wallace Hussain Ajaz Conner Dale Mehta Mehul Malinowski Henry Lazor John Huang Shiew-Mei Hare Don Lesko Lawrence Sporn Douglas Williams Roger |
| Affiliation: | (1) Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, HFD-350, 5600 Fishers Lane, Rockville, Maryland, 20857;(2) Present address: Abbott Laboratories, Abbott Park, Illinois, 60064;(3) Present address: United States Pharmacopeia, Rockville, Maryland, 20852-1790 |
| Abstract: | Pharmaceutical Research - Bioavailability and/or bioequivalence studies play a key role in the drug development period for both new drug products and their generic equivalents. For both, these... |
| Keywords: | bioavailability bioequivalence guidances New Drug Applications Abbreviated New Drug Applications generic drugs |
| 本文献已被 SpringerLink 等数据库收录！ | |