title: When are bioavailability studies required? A German proposal.
abstract: The Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), the German drug regulation authority, issued guidelines for determining whether bioavailability/bioequivalence studies are required for certain drugs. This decision tree is based on pharmacodynamic, pharmacokinetic, and physicochemical criteria. Details of this decision tree were worked out by an expert panel, the Bioavailability Commission at the BfArM. The decision tree has been in use by German regulatory authorities for more than 10 years. In the meantime, its essentials were adopted by the European Committee for Proprietary Medicinal Products (CPMP) and by the World Health Organization (WHO) for their "Guidelines on interchangeability of multisource pharmaceutical products." This article reviews the original decision tree of the BfArM and provides examples of drugs that have been assessed according to its rules. The current procedure of the German regulatory authorities for judging the necessity of bioavailability trials, which reflects the status quo of regulatory practice in Germany, is also discussed.
authors.affiliation: Abteilung Klinische Pharmakologie der Universität Göttingen, Germany.
authors.forename: C H
authors.initials: CH
authors.lastname: Gleiter
authors.forename: U
authors.initials: U
authors.lastname: Klotz
authors.forename: J
authors.initials: J
authors.lastname: Kuhlmann
authors.forename: H
authors.initials: H
authors.lastname: Blume
authors.forename: F
authors.initials: F
authors.lastname: Stanislaus
authors.forename: S
authors.initials: S
authors.lastname: Harder
authors.forename: H
authors.initials: H
authors.lastname: Paulus
authors.forename: C
authors.initials: C
authors.lastname: Poethko-Müller
authors.forename: M
authors.initials: M
authors.lastname: Holz-Slomczyk
mesh_terms: D001682:Biological Availability; D003663:Decision Trees; D005858:Germany; D006801:Humans; D004364:Pharmaceutical Preparations / Q000378:metabolism*; D010599:Pharmacokinetics; D013810:Therapeutic Equivalency
chemical_list: D004364:Pharmaceutical Preparations