Front Cover -- Volume 5; Preface to the Series-Second Edition; Preface to the Series-First Edition; About the Author; Contents; Part I -- Regulatory Guidance; 1 -- EU Guidelines to Good Manufacturing Practice: Medicinal Products for Human and Veterinary Use; 2 -- EDQM Certification; 3 -- GMP Audit Template, EU Guidelines; 4 -- WHO Good Manufacturing Guidelines; 5 -- Solid Oral Dosage Forms Validation; 6 -- Current Regulatory Status of Over-the-Counter Products; Part II -- Manufacturing Formulations; Part III -- Tablet Coating Formulations; Index; Back Cover
Summary
With thoroughly revised and expanded content, this Second Edition six-volume set compiles volumes from FDA New Drug Applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of issues concerning drug manufacturing
