Handbook of Pharmaceutical Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations

Volume Three, Liquid Products

Niazi, Sarfaraz K.

Taylor & Francis Ltd

02/2018

400

Mole

Inglês

9781138113794

15 a 20 dias

Descrição não disponível.
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
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