PQRI recommendations on particle-size analysis of drug substances used in oral dosage forms.
J Pharm Sci
; 96(6): 1451-67, 2007 Jun.
Article
em En
| MEDLINE
| ID: mdl-17238204
ABSTRACT
This document provides information for the Pharmaceutical Industry and the Federal Drug Administration (FDA) regarding the selection of suitable particle-size analysis techniques, development and validation of particle-size methods, and the establishment of acceptance criteria for the particle size of drug substances used in oral solid-dosage forms. The document is intended for analysts knowledgeable in the techniques necessary to conduct particle-size characterization (a table of acronyms is provided at the end of the document). It is acknowledged that each drug substance, formulation, and manufacturing process is unique and that multiple techniques and instruments are available to the analyst.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Tamanho da Partícula
/
Preparações Farmacêuticas
/
Tecnologia Farmacêutica
País/Região como assunto:
America do norte
Idioma:
En
Revista:
J Pharm Sci
Ano de publicação:
2007
Tipo de documento:
Article
País de afiliação:
Estados Unidos