1. Regulatory concerns at various phases of drug development.
- Author
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Aurecchia, Steven, Orloff, David, Sobel, Solomon, Aurecchia, S, Orloff, D, and Sobel, S
- Subjects
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PHARMACEUTICAL policy , *ANTILIPEMIC agents , *ARTERIOSCLEROSIS , *CLINICAL trials , *COMPARATIVE studies , *DRUG laws , *CLINICAL drug trials , *RESEARCH methodology , *MEDICAL cooperation , *RESEARCH , *SAFETY , *DRUG development , *EVALUATION research , *STANDARDS - Abstract
Presents a review of US Food and Drug Administration regulatory concerns at each phase of drug development. New drugs based on modifications of available agents; Drugs acting through novel mechanisms to alter plasma lipoprotein levels and structure; Therapies whose presumed salutary actions in decreasing atherosclerotic disease risk are via nonlipid effects.
- Published
- 1998
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