Sarfaraz K. Niazi

Handbook of Pharmaceutical Manufacturing Formulations

Volume Three, Liquid Products

• Broschiertes Buch

Produktbeschreibung

While liquid drugs do not share the compression problems of solid dosage forms, the filling problems of powder dosage forms, or the consistency problems of semisolid dosage forms, they do have their own set of considerations in the formulation and manufacturing stages. Highlights from Liquid Products, Volume Three include: practical details involved in complying with the current good manufacturing practice requirements in liquid manufacturing access to what an FDA auditor would be looking for during a liquid manufacturing audit issues that may arise during a US FDA inspection the protocols used for stability testing for new drugs and new dosage forms, drawn from the most current ICH guidelines

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Produktdetails

• Verlag: CRC Press
• 2. Auflage
• Seitenzahl: 402
• Erscheinungstermin: 26. Februar 2018
• Englisch
• Abmessung: 280mm x 216mm x 22mm
• Gewicht: 1007g
• ISBN-13: 9781138113794
• ISBN-10: 1138113794
• Artikelnr.: 52711000

Autorenporträt

Sarfaraz K. Niazi

Inhaltsangabe

REGULATORY AND MANUFACTURING GUIDANCE: Manufacturing Practice
Considerations in Liquid Formulations. Oral Solutions and Suspensions. The
FDA Drug Product Surveillance Program. Changes to Approved NDAs and ANDAs.
Formulation Considerations of Liquid Products. Container Closure Systems.
Material for Containers. Stability Testing of New Drug Substances and
Products. Stability Testing: Photostability Testing of New Drug Substances
and Products. Stability Testing for New Dosage Forms. Bracketing and
Matrixing Designs for Stability Testing of New Drug Substances and
Products. Evaluation of Stability Data. Stability Data Package for
Registration Applications in Climatic Zones III and IV. EU Guidelines to
Good Manufacturing Practice Medicinal Products for Human and Veterinary
Use. EDQM Certification. Impurities: Guideline for Residual Solvents.
Electronic Records and Signatures (CFR 21 Part 11 Compliance). GMP Audit
Template, EU Guidelines. Bioequivalence Testing Protocols. Dissolution
Testing of Liquid Dosage Forms. Approved Excipients in Liquid Forms.
MANUFACTURING FORMULATIONS: Manufacturing Formulations..