Description
Book SynopsisThe 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 authorâs 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
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
