Bioequivalence assessment: a pharmaceutical industry perspective.
Various aspects of bioequivalence are investigated in this paper. Some aspects dealing with bioequivalence studies conducted either during the development of the drug or after its marketing will be presented and discussed: Bioequivalence of highly variable drugs with the associated problem of widening the acceptance range or alternative solutions. Bioequivalence for the final market image. Bioequivalence for investigating the food effect. Bioequivalence in special population such as children, non Caucasian population. Bioequivalence based on in vitro data or literature. New approaches in bioequivalence interpretation. Bioequivalence and analytical methods which are not sensitive or specific enough.
Godbillon
J
J
Laboratoires Ciba-Geigy, Centre de Bioanalyse et de Pharmacocinétique, Rueil Malmaison, France.
Cardot
J M
JM
Lecaillon
J B
JB
Lefevre
G
G
Sioufi
A
A
D001682:Biological Availability; D002648:Child; D003710:Demography; D004304:Dosage Forms; D004341:Drug Evaluation; D004345:Drug Industry; D005502:Food; D006801:Humans; D011355:Prodrugs; D012680:Sensitivity and Specificity; D013810:Therapeutic Equivalency
D004304:Dosage Forms; D011355:Prodrugs