Handbook of pharmaceutical manufacturing formulations. Volume two, Uncompressed solid products / Sarfaraz K. Niazi.
By: Niazi, Sarfaraz [author.].
Material type:
BookPublisher: Boca Raton : CRC Press, 2019Edition: Third edition.Description: 1 online resource.Content type: text Media type: computer Carrier type: online resourceISBN: 9781315102948; 1315102943; 9781351593595; 1351593595; 9781351593601; 1351593609; 9781351593588; 1351593587.Subject(s): Drugs -- Dosage formsDDC classification: 615.19 Online resources: Taylor & Francis | OCLC metadata license agreement
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.
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