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PQRI recommendations on particle-size analysis of drug substances used in oral dosage forms

✍ Scribed by Sharon M. Snorek; John F. Bauer; Nallaperumal Chidambaram; William H. Doub; Eric P. Duffy; Frank M. Etzler; Richard N. Kelly; Justin J. Lane; Ronald L. Mueller; Hullahalli R. Prasanna; Chetan P. Pujara; Van D. Reif; Brian Scarlett; Joseph G. Stowell; Pascal H. Toma

Publisher: John Wiley and Sons
Year: 2007
Tongue: English
Weight: 202 KB
Volume: 96
Category: Article
ISSN: 0022-3549
DOI: 10.1002/jps.20822

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PQRI recommendations on particle-size an

PQRI recommendations on particle-size analysis of drug substances used in oral dosage forms

✍ Sharon M. Snorek; John F. Bauer; Nallaperumal Chidambaram; William H. Doub; Eric 📂 Article 📅 2007 🏛 John Wiley and Sons 🌐 English ⚖ 202 KB 👁 1 views

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