Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified release products: workshop summary report.
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.
Chen
Mei-Ling
ML
U.S. Food and Drug Administration, Silver Spring, Maryland, USA. meiling.chen@fda.hhs.gov
Shah
Vinod P
VP
Ganes
Derek
D
Midha
Kamal K
KK
Caro
James
J
Nambiar
Prabu
P
Rocci
Mario L
ML
Thombre
Avinash G
AG
Abrahamsson
Bertil
B
Conner
Dale
D
Davit
Barbara
B
Fackler
Paul
P
Farrell
Colm
C
Gupta
Suneel
S
Katz
Russell
R
Mehta
Mehul
M
Preskorn
Sheldon H
SH
Sanderink
Gerard
G
Stavchansky
Salomon
S
Temple
Robert
R
Wang
Yaning
Y
Winkle
Helen
H
Yu
Lawrence
L
D004364:Pharmaceutical Preparations; D013810:Therapeutic Equivalency
D004364:Pharmaceutical Preparations