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
Auflage
Sprache
Verlagsort
Verlagsgruppe
Zielgruppe
Für höhere Schule und Studium
Maße
Höhe: 280 mm
Breite: 210 mm
Gewicht
ISBN-13
978-0-367-38521-7 (9780367385217)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Klassifikation
Niazi, Sarfaraz K.
Autor*in
Pharmaceutical Scientist Inc., Deerfield, Illinois, USA
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.
