Handbook of Pharmaceutical Manufacturing Formulations: Volume Two, Uncompressed Solid Products

ISBN-13: 9780367385217 / Angielski / Miękka / 2019 / 392 str.

Sarfaraz K. Niazi

Opis

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.

Spis treści

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.

O autorze

Niazi, Sarfaraz K.