Title

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

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