Formulation and Analytical Development for Low-Dose Oral Drug Products

Formulation and Analytical Development for Low-Dose Oral Drug Products

ISBN: 9780470056097
Publisher: Wiley
Edition: 1
Publication Date: 2009-02-09
Number of pages: 496
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DESCRIPTION

There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.

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