Passive transdermal systems whitepaper incorporating current chemistry, manufacturing and controls (CMC) development principles
DOI
10.1208/s12249-011-9740-9
Document Type
Journal Article
Publication Date
3-1-2012
Publication Title
AAPS PharmSciTech
Volume
13
Issue
1
First Page
218
Last Page
230
Keywords
CMC, ICH, Quality by design (QbD), Residual drug, TDS
Abstract
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. © 2011 The Author(s).
Open Access
Hybrid_Gold
Repository Citation
Van Buskirk, G., Arsulowicz, D., Basu, P., Block, L., Cai, B., Cleary, G., Ghosh, T., González, M., Kanios, D., Marques, M., Noonan, P., Ocheltree, T., Schwarz, P., Shah, V., Spencer, T., Tavares, L., Ulman, K., Uppoor, R., & Yeoh, T. (2012). Passive transdermal systems whitepaper incorporating current chemistry, manufacturing and controls (CMC) development principles. AAPS PharmSciTech, 13 (1), 218-230. https://doi.org/10.1208/s12249-011-9740-9