Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified-release products: workshop summary report.
Chen
Mei-Ling
ML
U.S. Food and Drug Administration, USA. Meiling.Chen@fda.hhs.gov <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