Passive transdermal systems whitepaper incorporating current chemistry, manufacturing and controls (CMC) development principles.
In this whitepaper, the Manufacturing Technical Committee (MTC) of the Product Quality Research Institute has updated the 1997 Transdermal Drug Delivery Systems Scale-Up and Post Approval Change workshop report findings to add important new product development and control principles. Important topics reviewed include ICH harmonization, quality by design, process analytical technologies, product and process validation, improvements to control of critical excipients, and discussion of Food and Drug Administration's Guidance on Residual Drug in Transdermal and Related Drug Delivery Systems as well as current thinking and trends on in vitro-in vivo correlation considerations for transdermal systems.
Nonclinical Drug Development Consulting Services, LLC, Basking Ridge, New Jersey 07920, USA. vanbuskirk@drugdevconsult.com
Glenn A
GA
Van Buskirk
Daniel
D
Arsulowicz
Prabir
P
Basu
Lawrence
L
Block
Bing
B
Cai
Gary W
GW
Cleary
Tapash
T
Ghosh
Mario A
MA
González
David
D
Kanios
Margareth
M
Marques
Patrick K
PK
Noonan
Terrance
T
Ocheltree
Peter
P
Schwarz
Vinod
V
Shah
Thomas S
TS
Spencer
Lino
L
Tavares
Katherine
K
Ulman
Rajendra
R
Uppoor
Thean
T
Yeoh
D000279:Administration, Cutaneous; D000818:Animals; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D016503:Drug Delivery Systems / Q000379:methods / Q000639:trends; D055808:Drug Discovery / Q000379:methods*; D004345:Drug Industry / Q000379:methods*; D004493:Education; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000737:chemistry* / Q000378:metabolism
D004364:Pharmaceutical Preparations