title: Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report.
abstract: Regulatory approaches for evaluating therapeutic equivalence of multisource (or generic) drug products vary among different countries and/or regions. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Global harmonization for regulatory requirements may be promoted by a better understanding of factors underlying product performance and expectations from different regulatory authorities. This workshop provided an opportunity for pharmaceutical scientists from academia, industry and regulatory agencies to have open discussions on current regulatory issues and industry practices, facilitating harmonization of regulatory approaches for establishing therapeutic equivalence and interchangeability of multisource drug products.
authors.affiliation: Office of Pharmaceutical Science, Center forDrug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, USA. meiling.chen@fda.hhs.gov
authors.forename: Mei-Ling
authors.initials: ML
authors.lastname: Chen
authors.forename: Vinod P
authors.initials: VP
authors.lastname: Shah
authors.forename: Daan J
authors.initials: DJ
authors.lastname: Crommelin
authors.forename: Leon
authors.initials: L
authors.lastname: Shargel
authors.forename: Dennis
authors.initials: D
authors.lastname: Bashaw
authors.forename: Masood
authors.initials: M
authors.lastname: Bhatti
authors.forename: Henning
authors.initials: H
authors.lastname: Blume
authors.forename: Jennifer
authors.initials: J
authors.lastname: Dressman
authors.forename: Murray
authors.initials: M
authors.lastname: Ducharme
authors.forename: Paul
authors.initials: P
authors.lastname: Fackler
authors.forename: Terry
authors.initials: T
authors.lastname: Hyslop
authors.forename: Lorelei
authors.initials: L
authors.lastname: Lutter
authors.forename: Jose
authors.initials: J
authors.lastname: Morais
authors.forename: Eric
authors.initials: E
authors.lastname: Ormsby
authors.forename: Saji
authors.initials: S
authors.lastname: Thomas
authors.forename: Yu Chung
authors.initials: YC
authors.lastname: Tsang
authors.forename: Raja
authors.initials: R
authors.lastname: Velagapudi
authors.forename: Lawrence X
authors.initials: LX
authors.lastname: Yu
mesh_terms: D002170:Canada; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004353:Drug Evaluation, Preclinical / Q000379:methods; D016568:Drugs, Generic / Q000493:pharmacokinetics*; D005060:Europe; D006801:Humans; D038622:Internationality; D013810:Therapeutic Equivalency; D014481:United States; D014944:World Health Organization
chemical_list: D016568:Drugs, Generic