Phase IV Drug Development: Post-Marketing Studies

Principles and Practice of Pharmaceutical Medicine, Second Edition

Volumn , Issue , 2007, Pages 119-125

  Johnson Pratt, Lisa R ^a  

^a NONE

Author keywords

Clinical legal interface; Phase IV clinical development program objectives; Phase IV clinical trials; Phase IV drug development post marketing studies; Safety surveillance and draft ICH Guidance E2E

Indexed keywords

EID: 84889434613     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470093153.ch10     Document Type: Chapter

References (8)

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3. Hammer CE. 1990. Drug Development. CRC Press: Boca Raton, FL, USA.
4. Hampton JR. 1996. 'Alternatives to mega-trials in cardiovascular disease'. Cardiovasc. Drugs Ther. 10: 759-765.
5. International Conference on Harmonization Draft Guidance E2E: Pharmacovigilance planning. Draft version 4.1, November 11, 2003.
6. Makuch RW, Johnson MF. 1986. 'Some issues in the design and interpretation of 'negative' clinical studies'. Arch. Intern. Med. 146: 986-989.
7. Makuch RW, Johnson MF. 1989. 'Issues in planning and interpreting active control equivalence studies'. J. Clin. Epidemiol. 42: 503-511.
8. Spilker B. 1991. Guide to Clinical Trials. Raven: New York.