Handbook of Pharmaceutical Manufacturing Formulations

Semisolid Products

Sarfaraz K. Niazi (Autor)

Buch | Softcover

370 Seiten

2024 | 2nd edition
CRC Press (Verlag)
978-1-032-93131-9 (ISBN)

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The fourth volume in the series covers the techniques and technologies involved in the preparation of semisolid products such as ointments, creams, gels, suppositories, and special topical dosage forms. Drug manufacturers need a thorough understanding of the specific requirements that regulatory agencies impose on the formulation and efficacy determination of drugs contained in these formulations.

Highlights from Semisolid Products, Volume Four include:

coverage of over 350 formulations
valuable information on the difficult area of compliance
changes to approved new drug applications and abbreviated new drug applications
the evolving guidelines of ICH and when to conduct a regulatory review

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.

Erscheinungsdatum	16.10.2024
Zusatzinfo	3 Illustrations, black and white
Verlagsort	London
Sprache	englisch
Maße	210 x 280 mm
Gewicht	684 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
Themenwelt	Naturwissenschaften ► Biologie
ISBN-10	1-032-93131-0 / 1032931310
ISBN-13	978-1-032-93131-9 / 9781032931319
Zustand	Neuware