Handbook of Pharmaceutical Manufacturing Formulations

REGULATORY ANDMANUFACTURING GUIDANCE: Waiver of In Vivo Bioequivalence Study. Quality Risk Management. Pharmaceutical Quality System. Pharmaceutical Development. Pharmaceutical Development in CTD. Scale-Up and Postapproval Changes for Nonsterile Semisolid Dosage Forms: Manufacturing Equipment. GOOD Manufacturing Practice Guide for Active Pharmaceutical Ingredients. Validation of Analytical Procedures. Validation of Analytical Procedures: Methodology. Bioequivalence Testing of Topical Drugs. Good Manufacturing Requirements for Active Pharmaceutical Ingredients. FDA Active Pharmaceutical Ingredient Manufacturing Facility Inspection. Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances. Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products. Impurities in New Drug Substances. Impurities in New Drug Products. Formulation Factors in Semisolid Dosage Forms. GMP Audit Template, EU Guidelines. Dissolution Testing of Semisolid Dosage Forms. Approved Excipients in Semisolid Dosage Forms. MANUFACTURING FORMULATIONS: Regulatory and Manufacturing Guidance.