Handbook of pharmaceutical manufacturing formulations. Volume two, Uncompressed solid products / Sarfaraz K. Niazi. - Third edition. - 1 online resource
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.
9781315102948 1315102943 9781351593595 1351593595 9781351593601 1351593609 9781351593588 1351593587
10.1201/9781315102948 doi
Drugs--Dosage forms.
RS200
615.19