Handbook of Pharmaceutical Manufacturing Formulations Volume Two, Uncompressed Solid Products
Produktdetaljer
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 practices
- formulations for more than 400 pharmaceutical products, including currently approved products and innovative products such as small proteins, instantly liquifiable powders, and nanoparticles
- access to US FDA guidelines, as well as all major guidelines around the world
- identification and inclusion of the most often approved capsules and powders in the US
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
Preapproval Inspections
Formulation Factors in Uncompressed Dosage Forms
Bioequivalence Testing Protocols
Dissolution Testing of Uncompressed Solid Dosage Forms
Approved Excipients in Uncompressed Solid Dosage Forms
MANUFACTURING FORMULATIONS
Uncompressed Solids Formulations