title: Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified release products: workshop summary report.
abstract: Modified release products are complex dosage forms designed to release drug in a controlled manner to achieve desired efficacy and safety. Inappropriate control of drug release from such products may result in reduced efficacy or increased toxicity. This workshop provided an opportunity for pharmaceutical scientists from academia, industry, and regulatory agencies to discuss current industry practices and regulatory expectations for demonstrating pharmaceutical equivalence and bioequivalence of MR products, further facilitating the establishment of regulatory standards for ensuring therapeutic equivalence of these products.
authors.affiliation: U.S. Food and Drug Administration, Silver Spring, Maryland, 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: Derek
authors.initials: D
authors.lastname: Ganes
authors.forename: Kamal K
authors.initials: KK
authors.lastname: Midha
authors.forename: James
authors.initials: J
authors.lastname: Caro
authors.forename: Prabu
authors.initials: P
authors.lastname: Nambiar
authors.forename: Mario L
authors.initials: ML
authors.lastname: Rocci
authors.forename: Avinash G
authors.initials: AG
authors.lastname: Thombre
authors.forename: Bertil
authors.initials: B
authors.lastname: Abrahamsson
authors.forename: Dale
authors.initials: D
authors.lastname: Conner
authors.forename: Barbara
authors.initials: B
authors.lastname: Davit
authors.forename: Paul
authors.initials: P
authors.lastname: Fackler
authors.forename: Colm
authors.initials: C
authors.lastname: Farrell
authors.forename: Suneel
authors.initials: S
authors.lastname: Gupta
authors.forename: Russell
authors.initials: R
authors.lastname: Katz
authors.forename: Mehul
authors.initials: M
authors.lastname: Mehta
authors.forename: Sheldon H
authors.initials: SH
authors.lastname: Preskorn
authors.forename: Gerard
authors.initials: G
authors.lastname: Sanderink
authors.forename: Salomon
authors.initials: S
authors.lastname: Stavchansky
authors.forename: Robert
authors.initials: R
authors.lastname: Temple
authors.forename: Yaning
authors.initials: Y
authors.lastname: Wang
authors.forename: Helen
authors.initials: H
authors.lastname: Winkle
authors.forename: Lawrence
authors.initials: L
authors.lastname: Yu
mesh_terms: D004364:Pharmaceutical Preparations; D013810:Therapeutic Equivalency
chemical_list: D004364:Pharmaceutical Preparations