Harmonization of bioavailability and bioequivalence requirements.
Requirements for bioavailability (BA) and bioequivalence (BE) of drug products have evolved in different jurisdictions according to precedents established within the framework of existing laws. Thus, while the scientific principles behind the regulation and guidelines are common, it is often difficult for countries to agree on specific standards. This presentation examines some of the similarities and differences between European Community (EC) and North American requirements and indicates areas in which consensus may be achieved as well as those issues which may be more challenging.
McGilveray
I J
IJ
Bureau of Drug Research, Health Protection Branch, Ottawa, Ontario, Canada.
Ormsby
E
E
D001682:Biological Availability; D005062:European Union; D007880:Legislation, Drug; D013810:Therapeutic Equivalency