ABSTRACT
An authoritative and practical guide to the art and science of formulating drugs.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 manufa
Volume I: 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.Volume II: Regulatory and Manufacturing Guidelines. US 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. Process Validation: General Principles and Practices. Bioequivalence Regulatory Review Process and Audit. EU Guidelines to Good Manufacturing Practice Basic Requirements for Active Substances used as Starting Materials. Preapproval Inspections. Formulation Factors in Uncompressed Dosage Forms. Dissolution Testing of Uncompressed Solid Dosage Forms. Approved Excipients in Uncompressed Solid Dosage Forms. Uncompressed Solids Formulations. Volume III: Regulatory and Manufacturing Guidance. Manufacturing Practice Considerations in Liquid Formulations. Oral Solutions and Suspensions. The FDA Drug Product Surveillance Program. Changes to Approved NDAs and aNDAs. Formulation Considerations of Liquid Products. Container Closure Systems. Container Closure Systems. Stability Testing of New Drug Substances and Products. Stability Testing: Photostability Testing of New Drug Substances and Products. Stability Testing for New Dosage Forms. Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products. Evaluations of Stability Data. Stability Data Package for Registration Applications in Climatic Zones III and IV. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. EDQM Certification. Impurities: Guideline For Residual S
