Handbook of Pharmaceutical Manufacturing Formulations: Volume Two, Uncompressed Solid Products
Autor Sarfaraz K. Niazien Limba Engleză Paperback – 23 sep 2019
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
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Specificații
ISBN-13: 9780367385217
ISBN-10: 036738521X
Pagini: 386
Dimensiuni: 210 x 280 mm
Greutate: 0.72 kg
Ediția:2 New edition
Editura: CRC Press
Colecția CRC Press
Locul publicării:Boca Raton, United States
ISBN-10: 036738521X
Pagini: 386
Dimensiuni: 210 x 280 mm
Greutate: 0.72 kg
Ediția:2 New edition
Editura: CRC Press
Colecția CRC Press
Locul publicării:Boca Raton, United States
Cuprins
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.
Descriere
Providing methodologies that can serve as a reference point for new formulations, this volume covers uncompressed solids, which include formulations of powders, capsules, powders ready for reconstitution, and other similar products. It explores regulatory and manufacturing guidelines, registration of pharmaceuticals for human use, process validation, bioequivalence regulatory review process and audit, and preapproval inspections. Additional topics in this second volume in the Handbook of Pharmaceutical Manufacturing Formulations include formulation factors in uncompressed dosage forms, dissolution testing of uncompressed solid dosage forms, approved excipients in uncompressed solid dosage forms, and uncompressed solids formulations.