کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2487766 1114431 2007 17 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
PQRI Recommendations on Particle-Size Analysis of Drug Substances Used in Oral Dosage forms
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی اکتشاف دارویی
پیش نمایش صفحه اول مقاله
PQRI Recommendations on Particle-Size Analysis of Drug Substances Used in Oral Dosage forms
چکیده انگلیسی
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.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 96, Issue 6, June 2007, Pages 1451-1467
نویسندگان
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