Τόμος 4 (1986) – Τεύχος 1 – Άρθρο 1 – Επιθεώρηση Κλινικής Φαρμακολογίας και Φαρμακοκινητικής-Ελληνική Έκδοση – Volume 4 (1986) – Issue 1 – Article 1 – Epitheorese Klinikes Farmakologias και Farmakokinetikes-Greek Edition

Generic Drugs: Criteria based on metabolic and pharmacokinetic studies in humans for the assessment of their bioequivalence

A. BENAKIS AND CH. T. PLESSAS

^{Εργαστήριο Μεταβολισμού Φαρμάκων, Τομέας Φαρμακολογίας, Πανεπιστήμιο Γενεύης, Ελβετία}

^{Laboratory of Drug Metabolism, Department of Pharmacology, University of Geneva, Switzerland}

3: 228-237 (1986)

PHARMAKON-Press: Epitheorese Klin. Farmakol. Farmakokinet.

3: 228-237 (1986)

 Generic Drugs, metabolic studies, pharmacokinetic studies, bioequivalence

The last years we speak more often about generic name drugs: integral gene­rics (same active compound, same formulation as Brand name drug), branded generics (equi­valent generics from the same producer), equi­valent generics (same active compound, diffe­rent formulation but same pharmacodynamic effect) and generics plus (same active com­pound different formulation but improved ef­fect). The generic drug is assumed to be equi­valent and interchangeable with the brand name drug except for the category generic plus, which tries to improve the original for­mula, for example in terms of longer lasting effect. The bioequivalence of a generic drug with a brand name drug must be established on the basis of pharmacokinetic parameters (lack-time, maximum drug concentration in the plasma, time required after administration of the drug to obtain maximum value, area under the plasma concentration time curve) issued from bioavailability studies which are based entirely on blood level values and on generally accepted experimental protocol.

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