Handbook of pharmaceutical manufacturing formulations. Volume two, Uncompressed solid products - Niazi, Sarfaraz, 1949- (Boca Raton : CRC Press, 2019)
Previous edition: New York: Informa Healthcare, 2009.
Part I. Regulatory and Manufacturing Guidelines Chapter 1. U.S. FDA Good Manufacturing Practices Chapter 2. Guideline on the Common Technical Document for the Registration of Pharmaceuticals for Human Use Chapter 3. Process Validation: General Principles and Practices Chapter 4. Bioequivalence Regulatory Compliance Chapter 5. Bioequivalence Regulatory Review Process and Audit Chapter 6. EU Guidelines to Good Manufacturing Practice: Active Drug Substance Chapter 7. FDA Pre-approval Inspections Chapter 8. Formulation Factors in Uncompressed Dosage Forms Chapter 9: Solid-State Properties. Chapter 10: Formulation of Flavor. Part II. Manufacturing Formulations Uncompressed Solids Formulations Part III. Commercial Pharmaceutical Formulations. Commercial Pharmaceutical Formulations.
OCLC-licensed vendor bibliographic record.
Keywords: Drugs -- Dosage forms