Full Description
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 practicesformulations for more than 400 pharmaceutical products, including currently approved products and innovative products such as small proteins, instantly liquifiable powders, and nanoparticlesaccess to US FDA guidelines, as well as all major guidelines around the worldidentification and inclusion of the most often approved capsules and powders in the US
Contents
REGULATORY AND MANUFACTURING GUIDELINESU.S. FDA Good Manufacturing PracticesGMP Audit Template, EU GuidelinesGuideline on the Common Technical Document for the Registration of Pharmaceuticals for Human UseProcess Validation: General Principles and PracticesBioequivalence Regulatory ComplianceBioequi valence Regulatory Review Process and AuditEU Guidelines to Good Manufacturing PracticePreapproval InspectionsFormulation Factors in Uncompressed Dosage FormsBioequivalence Testing ProtocolsDissolution Testing of Uncompressed Solid Dosage FormsApproved Excipients in Uncompressed Solid Dosage FormsMANUFACTURING FORMULATIONSUncompressed Solids Formulations
