The failure to show bioequivalence is not evidence against generics

British Journal of Clinical Pharmacology

Volumn 70, Issue 3, 2010, Pages 452-453

  García Arieta, Alfredo ^a  

^a Department of Human Use Medicines   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; GENERIC DRUG;

BIOEQUIVALENCE; DEMOGRAPHY; DRUG BIOAVAILABILITY; DRUG FORMULATION; DRUG LEGISLATION; DRUG QUALITY; FOOD AND DRUG ADMINISTRATION; HEALTH ECONOMICS; LETTER; PRESCRIPTION; PRIORITY JOURNAL; STATISTICAL SIGNIFICANCE; VALIDITY;

DRUGS, GENERIC; HUMANS; STATISTICS AS TOPIC; THERAPEUTIC EQUIVALENCY;

EID: 77955759110     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2010.03684.x     Document Type: Letter

References (3)

1. Del Tacca M, Pasqualetti G, Di Paolo A, Virdis A, Massimetti G, Gori G, Versari D, Taddei S, Blandizzi C. Lack of pharmacokinetic bioequivalence between generic and branded amoxicillin formulations. A post-marketing clinical study on healthy volunteers. Br J Clin Pharmacol 2009 68 : 34 42.
2. Directive 2001/83/EC of the European Parliament and of the Council of 6 April 2001 on the Community Code Relating to Medicinal Products for Human Use. OJEC 2004 L311 : 67 128.
3. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Rockville, MD : U.S.Food and Drug Administration, 2009. Available at http://www.accessdata.fda.gov/scripts/cder/ ob/default.cfm