Original brands and generic preparations;Originale und Nachahmer

Medizinische Klinik

Volumn 95, Issue 1, 2000, Pages 26-30

  Petersen, Karl Uwe ^a  

^a Pharmakologe und Toxikologe   (Germany)

Author keywords

Bioavailability; Bioequivalence; Generic drugs; Pharmaceutical equivalence; Therapeutic equivalence; Therapeutic index

Indexed keywords

ACETYLSALICYLIC ACID; AMINOGLYCOSIDE; ANTICOAGULANT AGENT; CARBAMAZEPINE; CLONIDINE; DISOPYRAMIDE; GENERIC DRUG; GLYCOSIDE; GUANETHIDINE; ISOPRENALINE; LEVOTHYROXINE; LITHIUM; MINOXIDIL; PHENYTOIN; PRAZOSIN; PRIMIDONE; PROCAINAMIDE; QUINIDINE; THEOPHYLLINE; VALPROIC ACID; VERAPAMIL;

BIOEQUIVALENCE; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG MONITORING; MEDICAL DOCUMENTATION; REVIEW;

EID: 0034650382     PISSN: 07235003     EISSN: None     Source Type: Journal    
DOI: 10.1007/bf03044977     Document Type: Review

References (20)

1. Bochner F, Somogyi AA, Wilson KM. Bioinequivalece of four 100 mg oral aspirin formulations in healthy volunteers. Clin Pharmacokinet 1991;21:394-9.
2. Colaizzi JL, Lowenthal DT. Critical therapeutic categories: a contraindication to generic substitution? Clin Ther 1986;8:370-9.
3. Copeland PM. Two cases of therapeutic failure associated with levothyroxine brand interchange. Ann Pharmacother 1995;29:482-5.
4. Dong BJ, Brown CH. Hypothyroidism resulting from generic levothyroxine failure. J Am Board Fam Pract 1991;4:167-70.
5. Dubovsky SL. Severe nortriptyline intoxication due to change from a generic to a trade preparation. J Nerv Ment Dis 1987;175:115-7.
6. Gleiter CH, Gundert-Remy U. Bioinequivalence and drug toxicity. How great is the problem and what can be done? Drug Saf 1994;11:1-6.
7. Graffner C, Josefsson K, Stockman O. Intra- and inter-subject variation of erythromycin absorption from single-unit and multiple-unit enteric-coated products. Biopharm Drug Dispos 1986;7:163-71.
8. Joshi MV, Gokhale PC, Pohujani SM, et al. Biomequivalence of marketed diltiazem preparations. Eur J Clin Pharmacol 1990;39:189-90.
9. Keith LG, Oleszczuk JJ, Stika CS, et al. Generics: what's in a name? Int J Fertil Womens Med 1998;43:139-49.
10. Koeleman HA, Wessels JC, Steyn HS, et al. New bioavailability parameters to compare the efficacy of antimicrobial drugs in dosage forms. Int J Clin Pharmacol Ther Toxicol 1991;29:451-3.
11. Locniskar A, Greenblatt DJ, Harmatz JS, et al. Bioinequivalence of a generic brand of diazepam. Biopharm Drug Dispos 1989;10:597-605.
12. Meyer MC, Straughn AB, Jarvi EJ, et al. The bioinequivalence of carbamazepine tablets with a history of clinical failures. Pharm Res 1992;9:1612-6.
13. Neuvonen PJ, Bardy A, Lehrovaara R. Effect of increased bioavailability of phenytoin tablets on serum phenytoin concentration in epileptic out-patients. Br J Clin Phannacol 1979;8:37-41.
14. Peran S, Garriga MJ, Morreale de Escobar G, et al. Increase in plasma thyrotropin levels in hypothyroid patients during treatment due to a defect in the commercial preparation. J Clin Endocrinol Metab 1997,82:3192-5.
15. Randnitis EJ, Sedman AJ, Welling PG, et al. Effect of a high-fat meal on the bioavailability of a polymer-coated erythromycin particle tablet formulation. J Clin Pharmacol 1989;29:79-84.
16. Schwartz LL. The debate over substitution policy. Its evolution and scientific basis. Am J Med 1985;79:38-44.
17. Soryal J, Richens A. Bioavailability and dissolution of proprietary and generic formulations of phenytoin. J Neurol Neurosurg Psychiat 1992;55:688-91.
18. Venho VM, Palva ES, Konno K, et al. The value of comparative bioavailability studies of marketed drugs in drug control. An example with erythromycin stearate. Meth Find Exp Clin Pharmacol 1987;9:445-7.
19. Waldman SA, Morganroth J. Effects of food on the bioequivalence of different verapamil sustained-release formulations. J Clin Phannacol 1995;35:163-9.
20. Windeler J, Trampisch HJ. Empfehlungen zur Durchführung von Studien zur therapeutischen Äquivalenz. Inf Biom Epidem Med Biol 1995;26:350-5.