Bioequivalence, therapeutic equivalence and generic drugs

Acta Clinica Belgica

Volumn 64, Issue 5, 2009, Pages 379-383

  Verbeeck, R K ^a  

^a UNIVERSITÉ CATHOLIQUE DE LOUVAIN   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA ADRENERGIC RECEPTOR BLOCKING AGENT; ANTITHROMBOCYTIC AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CARDIOVASCULAR AGENT; CHONDROITIN SULFATE; CYCLOSPORIN; DIGOXIN; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; FLECAINIDE; GENERIC DRUG; HEPARIN; ITRACONAZOLE; LITHIUM; PHENYTOIN; RAPAMYCIN; TACROLIMUS; THEOPHYLLINE; VALPROIC ACID;

ALLERGIC REACTION; AREA UNDER THE CURVE; BELGIUM; BIOEQUIVALENCE; DEATH; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG CONTAMINATION; DRUG EFFICACY; DRUG MARKETING; DRUG QUALITY; DRUG SAFETY; EDITORIAL; FOOD AND DRUG ADMINISTRATION; GOOD CLINICAL PRACTICE; GOOD MANUFACTURING PRACTICE; HUMAN; MAXIMUM PLASMA CONCENTRATION; PATENT; PEER REVIEW; SIDE EFFECT; TIME TO MAXIMUM PLASMA CONCENTRATION; ABSORPTION; NOTE; PHARMACOKINETICS;

ABSORPTION; AREA UNDER CURVE; DRUGS, GENERIC; HUMANS; THERAPEUTIC EQUIVALENCY;

EID: 77449111940     PISSN: 00015512     EISSN: None     Source Type: Journal    
DOI: 10.1179/acb.2009.063     Document Type: Editorial

References (16)

1. Dupont AC and Heller F: Generics and cost-effective prescribing in Belgium - does bioequivalence always translate in therapeutic equivalence? Acta Clin. Belg 2009;5:406-414.
2. Heller FR and Dupont AC: Generics - need for clinical concern? Acta Clin. Belg 2009;5:415-422.
3. Buxton ILO: Pharmacokinetics and pharmacodynamics - the dynamics of drug absorption, distribution, action and elimination. In "Goodman & Gilman's The Pharmacological Basis of Therapeutics" (eleventh edition), Brunton LL, Lazo JS and Parker KL (eds.), McGraw-Hill, New York, pp. 1-39,2006.
4. Hauschke D, Steinijans V and Pigeot I: Bioequivalence Studies in Drug Development - Methods and Applications, John Wiley & Sons Ltd. (UK), 2007.
5. Benet LZ: Understanding bioequivalence testing. Transplant. Proc. 31(Suppl 3A):7S-9S,1999.
6. Dhanaraj M and Jayavelu A: Non-equivalence of bioavailability between generic and branded form of sodium valproate. Neu rol. India 52:398,2005 (Letter to the Editor).
7. Pasqualotto AC and Denning DW: Generic substitution of itraconazole resulting in subtherapeutic levels and resistance. Int. J. Antimicrob. Agents 30:93-94,2007 (Letter to the Editor).
8. Hoharitanon S, Chaichalotornkul J and Sindhupak W: a comparison of the efficacy between two itraconazole generic products and the innovative itraconazole in the treatment of tinea pedis.J. Med. Assoc. Thai 88 (Suppl 4): S167-S172,2005.
9. Kesselheim AS, Misono AS, Lee JL, Stedman MR, Brookhart MA, Choudhry NK and Shrank WH: Clinical equivalence of generic and brand-name drugs used in cardiovascular disease. J. Am. Med. Assoc. 300:2514-2526,2008.
10. Niazi SK: Handbook of Bioequivalence Testing, "Drugs and the Pharmaceutical Sciences", vol. 171, Informa Healthcare (Ney York), 2007.
11. EMEA Note for Guidance on the Investigation of Bioavailability and Bioequivalence. CPMP/EWP/QWP/1401/98, London, 26 July 2001.
12. EMEA Guideline on the Investigation of Bioequivalence, CPMP/ EWP/QWP/1401/98, London, 24 July 2008 (draft).
13. Williams RL: Therapeutic equivalence of generic drugs - Response to National Association of Boards of Pharmacy, Center for Drug Evaluation and Research, FDA, 1997 (www.fda.gov/cder/news.ntiletter.htm).
14. Health Canada Guidance for Industry: Bioequivalence requirements - critical dose drugs. Health Products and Food Branch, Health Canada, Ottawa, 2006.
15. McLaughlin DB: generic drug use in epilepsy. Neurol. Asia 12 (Suppl. 1): 25-26,2007.
16. Blossom DB et al.: Outbreak of adverse reactions associated with contaminated heparin. N. Eng. J. Med. 359:2674-2684,2008.