TY - BOOK AU - Niazi,Sarfaraz TI - Handbook of pharmaceutical manufacturing formulations SN - 9781315102948 AV - RS200 U1 - 615.19 23 PY - 2019/// CY - Boca Raton PB - CRC Press KW - Drugs KW - Dosage forms N1 - 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.

UR - https://www.taylorfrancis.com/books/9781315102948 UR - http://www.oclc.org/content/dam/oclc/forms/terms/vbrl-201703.pdf ER -