Regulatory concerns at various phases of drug development

American Journal of Cardiology

Volumn 81, Issue 8 A, 1998, Pages 2F-4F

  Aurecchia, Steven ^a   Orloff, David ^a   Sobel, Solomon ^a   Dujovne, Carlos A ^b  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b Kansas Foundation for Clinical Pharmacology   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HIGH DENSITY LIPOPROTEIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE; LOW DENSITY LIPOPROTEIN; LOW DENSITY LIPOPROTEIN CHOLESTEROL; NICOTINIC ACID;

ATHEROSCLEROSIS; CLINICAL TRIAL; CONFERENCE PAPER; DRUG DEVELOPMENT; DRUG EFFICACY; DRUG POTENCY; DRUG SAFETY; DRUG TOLERABILITY; FOOD AND DRUG ADMINISTRATION; PHARMACODYNAMICS; PHARMACOKINETICS; PRACTICE GUIDELINE; PRIORITY JOURNAL; TREATMENT OUTCOME;

EID: 0032560103     PISSN: 00029149     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0002-9149(98)00250-1     Document Type: Conference Paper

References (8)

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8. The extent of population exposure to assess clinical safety: for drugs intended for long-term treatment of non-life-threatening conditions. International Conference on Harmonization E-1A, March 1995.