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Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Authors
Publisher CRC Press Inc.
Year 2019
Edition Third
Pages 420
Version hardback
Readership level Professional and scholarly
Language English
ISBN 9781138103221
Categories Pharmacology
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Book description

The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Three, Liquid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this third volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author's own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.


Features:


Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions


Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing


Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements


Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Table of contents

Part I: Regulatory and Manufacturing Guidance





Manufacturing Considerations in Liquid Formulations





Oral Solutions and Suspensions





The FDA Drug Product Surveillance Program





Changes to Approved NDAs and aNDAs





Formulation Considerations of Liquid Products





Container Closure Systems





Material for Containers





Stability Testing of New Drug Substances and Products





Stability Testing: Photostability Testing of New Drug Substances and Products





Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products





Evaluation of Stability Data





Stability Data Package for Registration Applications in Climatic Zones III and IV





EU Guidelines to Good Manufacturing Practice: Medicinal Products for Human and Veterinary Use





Impurities: Guideline for Residual Solvents





Electronic Records and Signatures (CFR 21 Part 11 Compliance)





Product-Specific Bioequivalence Testing Protocols





Formulation Considerations





Pediatric Pharmaceutical EU Legislation





Pediatric Formulations





SOP and Specification to Establish Electronic Submission to Regulatory Agencies





Part II: Manufacturing Formulations





Part III: Commercial Pharmaceutical Products

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