392 pages | 3 B/W Illus.
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:
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
Formulation Factors in Uncompressed Dosage Forms
Bioequivalence Testing Protocols
Dissolution Testing of Uncompressed Solid Dosage Forms
Approved Excipients in Uncompressed Solid Dosage Forms
Uncompressed Solids Formulations