Overview

Providing methodologies that can serve as a reference point for new formulations, the second volume covers uncompressed solids, which include formulations of powders, capsules, powders ready for reconstitution, and other similar products. Highlights from Uncompressed Solid Products, Volume Two include: the fundamental issues of good manufacturing practices formulations for more than 400 pharmaceutical products, including currently approved products and innovative products such as small proteins, instantly liquifiable powders, and nanoparticles access to US FDA guidelines, as well as all major guidelines around the world identification and inclusion of the most often approved capsules and powders in the US

Full Product Details

Author:   Sarfaraz K. Niazi (Pharmaceutical Scientist Inc., Deerfield, Illinois, USA)
Publisher:   Taylor & Francis Ltd
Imprint:   CRC Press
Edition:   2nd edition
Weight:   0.716kg
ISBN:  

9780367385217

ISBN 10:   036738521
Pages:   386
Publication Date:   23 September 2019
Audience:   College/higher education ,  General/trade ,  Tertiary & Higher Education ,  General
Format:   Paperback
Publisher's Status:   Active
Availability:   In Print  
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Table of Contents

REGULATORY AND MANUFACTURING GUIDELINES: U.S. FDA Good Manufacturing Practices. GMP Audit Template, EU Guidelines. Guideline on the Common Technical Document for the Registration of Pharmaceuticals for Human Use. Process Validation: General Principles and Practices. Bioequivalence Regulatory Compliance. Bioequi valence Regulatory Review Process and Audit. EU Guidelines to Good Manufacturing Practice. Preapproval Inspections. Formulation Factors in Uncompressed Dosage Forms. Bioequivalence Testing Protocols. Dissolution Testing of Uncompressed Solid Dosage Forms. Approved Excipients in Uncompressed Solid Dosage Forms. MANUFACTURING FORMULATIONS: Uncompressed Solids Formulations.

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Niazi, Sarfaraz K.

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