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AAPS Update

AAPS Update 246 AAPS Update AAPS — YOUR FORMULA FOR SUCCESS! January 2008 2008 Arden Conference: Particle AAPS Workshop on Current Topics and Powder Technologies for Solid in GLP Bioanalysis: Assay Reproducibility Dosage Forms for Incurred Samples — Implications of Crystal City Recommendations February 3–8, 2008 The Thayer Hotel February 7–8, 2008 West Point, NY Hyatt Regency Crystal City Arlington, VA Background Background This program is designed to provide fundamental under- The FDA has been particularly concerned recently about standing and latest technologies on particle and powder for adequately establishing the specific method validation param- pharmaceutical scientists engaged in solid dosage formula- eter assay reproducibility for quantitative methods that tions. It will also give an overview of fundamental principles support both pharmacokinetics and bioequivalence. The for particle and powders. Detailed presentations will cover Division of Scientific Investigations reports that nanoparticles and particle engineering for novel drug deliv- ery, as well as characterization and modeling of powder flow b During inspections the investigators found large inconsis- and powder compaction for traditional solid dosage forms. tencies between original and repeated results from accept- Each topic will include lectures from experts in the field able runs; followed by in-depth group discussion and case studies http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Pharmaceutical Research Springer Journals

AAPS Update

Pharmaceutical Research , Volume 25 (1) – Nov 27, 2007
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Publisher
Springer Journals
Copyright
Copyright © 2007 by Springer Science+Business Media, LLC
Subject
Biomedicine; Biomedical Engineering; Medical Law ; Biochemistry, general; Pharmacy; Pharmacology/Toxicology
ISSN
0724-8741
eISSN
1573-904X
DOI
10.1007/s11095-007-9505-z
Publisher site
See Article on Publisher Site

Abstract

246 AAPS Update AAPS — YOUR FORMULA FOR SUCCESS! January 2008 2008 Arden Conference: Particle AAPS Workshop on Current Topics and Powder Technologies for Solid in GLP Bioanalysis: Assay Reproducibility Dosage Forms for Incurred Samples — Implications of Crystal City Recommendations February 3–8, 2008 The Thayer Hotel February 7–8, 2008 West Point, NY Hyatt Regency Crystal City Arlington, VA Background Background This program is designed to provide fundamental under- The FDA has been particularly concerned recently about standing and latest technologies on particle and powder for adequately establishing the specific method validation param- pharmaceutical scientists engaged in solid dosage formula- eter assay reproducibility for quantitative methods that tions. It will also give an overview of fundamental principles support both pharmacokinetics and bioequivalence. The for particle and powders. Detailed presentations will cover Division of Scientific Investigations reports that nanoparticles and particle engineering for novel drug deliv- ery, as well as characterization and modeling of powder flow b During inspections the investigators found large inconsis- and powder compaction for traditional solid dosage forms. tencies between original and repeated results from accept- Each topic will include lectures from experts in the field able runs; followed by in-depth group discussion and case studies

Journal

Pharmaceutical Research – Springer Journals

Published: Nov 27, 2007

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