Passive transdermal systems whitepaper incorporating current chemistry, manufacturing and controls (CMC) development principles.
AAPS PharmSciTech
; 13(1): 218-30, 2012 Mar.
Article
em En
| MEDLINE
| ID: mdl-22215291
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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Preparações Farmacêuticas
/
Química Farmacêutica
/
Sistemas de Liberação de Medicamentos
/
Indústria Farmacêutica
/
Descoberta de Drogas
Limite:
Animals
/
Humans
Idioma:
En
Revista:
AAPS PharmSciTech
Assunto da revista:
FARMACOLOGIA
Ano de publicação:
2012
Tipo de documento:
Article
País de afiliação:
Estados Unidos