Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2487766 | Journal of Pharmaceutical Sciences | 2007 | 17 Pages |
Abstract
This document provides information for the Pharmaceutical Industry and the Federal Drug Administration (FDA) regarding the selection of suitable particleâsize analysis techniques, development and validation of particleâsize methods, and the establishment of acceptance criteria for the particle size of drug substances used in oral solidâdosage forms. The document is intended for analysts knowledgeable in the techniques necessary to conduct particleâsize 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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Authors
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,