Handbook of Pharmaceutical Manufacturing Formulations

Volume Two, Uncompressed Solid Products
2. New Auflage 2009
ISBN: 978-1-4200-8118-3
Verlag: Taylor & Francis Inc

Buch, Englisch, 392 Seiten, Format (B × H): 289 mm x 228 mm, Gewicht: 2298 g

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, VolumeTwo 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

Zielgruppe

Pharmaceutical manufacturers, and quality assurance and production personnel.

Autoren/Hrsg.

Niazi, Sarfaraz K.

Fachgebiete

• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie

Inhaltsverzeichnis

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.

Über Autor(innen)

Niazi, Sarfaraz K.