The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume One, Compressed Solid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this first volume of a six-volume set, compiles data from FDA new drug applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of GMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.
Bioequivalence Testing Rationale and Principles
Bioequivalence Testing Protocols-FDA-Compressed Dosage Forms
GMP Audit Template, EU Guidelines. Guidance on Formulating Compressed Solids
Appendix I: Dissolution Testing Requirements of Compressed Dosage Forms
Appendix II: Approved Excipients in Compressed Solid Dosage Forms