Handbook of Pharmaceutical Manufacturing Formulations, Third Edition Volume Three, Liquid Products

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

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