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http://dx.doi.org/10.1201/9780203483657
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Front MatterAbstract - Hi-Res PDF (468 KB) - PDF w/links (468 KB)
Chapter 1. Overview of Drug Development and the FDADouglas J. PisanoAbstract - Hi-Res PDF (621 KB) - PDF w/links (622 KB)
Chapter 2. Regulatory StrategyJacqueline A. DombroskiAbstract - Hi-Res PDF (652 KB) - PDF w/links (652 KB)
Chapter 3. What Is an IND?Robert G. Pietrusko, Thomas ClassAbstract - Hi-Res PDF (2967 KB) - PDF w/links (1281 KB)
Chapter 4. Formatting, Assembling, and Submitting the New Drug Application (NDA)David J. Pizzi, Janet C. RaeAbstract - Hi-Res PDF (1697 KB) - PDF w/links (990 KB)
Chapter 5. Meeting with the FDAAlberto GrignoloAbstract - Hi-Res PDF (584 KB) - PDF w/links (584 KB)
Chapter 6. BiologicsJames G. Kenimer, John J. JessopAbstract - Hi-Res PDF (983 KB) - PDF w/links (764 KB)
Chapter 7. FDA Medical Device RegulationBarry SallAbstract - Hi-Res PDF (2808 KB) - PDF w/links (1297 KB)
Chapter 8. The Development of Orphan DrugsMarlene E. HaffnerAbstract - Hi-Res PDF (510 KB) - PDF w/links (510 KB)
Chapter 9. Good Clinical PracticesRobert BuckleyAbstract - Hi-Res PDF (701 KB) - PDF w/links (702 KB)
Chapter 10. Good Manufacturing Practices (GMPs) and Enforcement ActionsCatherine A. Hay, Florence A. KaltovichAbstract - Hi-Res PDF (587 KB) - PDF w/links (588 KB)
Chapter 11. Electronic SubmissionsShylendra Kumar, Vah‚ GhahramanAbstract - Hi-Res PDF (4345 KB) - PDF w/links (1441 KB)
Chapter 12. The Practice of Regulatory AffairsDavid S. MantusAbstract - Hi-Res PDF (665 KB) - PDF w/links (666 KB)
Chapter 13. A Primer of Drug/Device Law, or Whats the Law and How Do I Find It?Josephine C. BabiarzAbstract - Hi-Res PDF (693 KB) - PDF w/links (694 KB)
