Acceptance limits for bioequivalence studies

Clinical Research and Regulatory Affairs

Volumn 14, Issue 2, 1997, Pages 127-137

  Rhodes, C T ^a  

^a UNIVERSITY OF RHODE ISLAND   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOEQUIVALENCE; DRUG BIOAVAILABILITY; DRUG COST; DRUG MANUFACTURE; DRUG MARKETING; DRUG PENETRATION; DRUG POTENCY; DRUG RESEARCH; DRUG SOLUBILITY; FOOD AND DRUG ADMINISTRATION;

EID: 0030745467     PISSN: 10601333     EISSN: None     Source Type: Journal    
DOI: 10.3109/10601339709019634     Document Type: Article

References (10)

1. C.T. Rhodes, Clinical Research and Drug Regulatory Affairs 11. 181-184 (1994).
2. L. Benet and J. Goyan, Pharmacotherapy 15, 433-440 (1995).
3. C.T. Rhodes, Clinical Research and Drug Regulatory Affairs 12, 267-272 (1995).
4. S.E. Rosenbaum and J. Lam, Drug Development and Industrial Pharmacy 23, 337-344 (1997).
5. CFR 320-33.
6. Letter from James S. Benson, Acting Commissioner of Food and Drugs, 1 October, 1990.
7. FDA Compliance Program Guide Manual, published 15 August, 1994.
8. SUPAC Guidelines, published November (1995).
9. C.T. Rhodes, Chapter on Bioequivalence in Drugs for Clinical Trials, edited by Monkhouse and Rhodes, Marcel Dekker (1997).
10. S.E. Rosenbaum, A.A. Carter and M.N. Dudley, Drug Development and Industrial Pharmacy 9, 1115-1139 (1995).