Generic medication; Bioequivalence; Drug prescription; Reference price; Internation non-proprietary name
Abstract :
[en] Complementarily to a previous publication, this paper tries to answer a few commonly asked questions about--generic medications: pharmaceutical quality, bioequivalence and therapeutic equivalence, substitution, etc. A summary of recent regulations about reference price and prescription by non-proprietary name, aiming at the promotion of generic medication prescription is also presented.
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Delporte, Jean-Pierre ; Université de Liège - ULiège > Département de pharmacie > Economie du médicament - Phamacie hospitalière
Delattre, Luc ; Université de Liège - ULiège > Département de pharmacie > Département de pharmacie
Herné, Patrick ; Université de Liège - ULiège > Département de pharmacie > Déontologie et législation pharmaceutiques
Language :
French
Title :
Le point sur les medicaments generiques et sur la prescription sous denomination commune
Alternative titles :
[en] Generic Medications and Prescription by Non-Proprietary Name
Publication date :
2006
Journal title :
Revue Médicale de Liège
ISSN :
0370-629X
eISSN :
2566-1566
Publisher :
Université de Liège. Revue Médicale de Liège, Belgium
Delporte J.-P.- Les médicaments génériques. Rev Med Liège, 2002, 57, 13-22.
Commitee for proprietary medicinal product. Note for guidance on the investigation of bioavailability and bioequivalence. Doc. CPMP.EWP/QWP/1401/98 Draft. London, December 1998.
Gleiter C.H. et al.- When are bioavailability studies required. J. Clin. Pharmacol, 1998, 38, 904-911.
FDA: Waiver of in vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms based on a Biopharmaceutics Classification System, 2000.
Lindberg M., Kopp S, Dressman J.B.- Classification of orally administered drugs on the World Health Organization Model List of Essential Medicines according to the biopharmaceutics classification system. Eur. J. of Pharmaceutics and Biopharmaceutics, 2004, 58, 265-278.
Nightingale S.L., Morrisson J.C.- Generic drugs and the prescribing physician. JAMA, 1987, 9, 1200-1204.
MONITEUR BELGE, 20 septembre 2005: AR du 10 août 2005 (F.2005-2348, F.2005-2349, F.2005-2351, F.2005-2352).
MONITEUR BELGE, 20 mai 2005: loi du 27 avril 2005.
Folia Pharmacothérapeutica. Passer d'une spécialité à une autre: quelques commentaires, 2006, 33, 2.
