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· 분류 : 외국도서 > 교육/자료 > 참고자료 > 일반
· ISBN : 9781032920184
· 쪽수 : 456쪽
· 출판일 : 2024-10-14
목차
Part I: Regulatory and Manufacturing Guidance
Manufacturing 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
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
Impurities: Guideline for Residual Solvents
Electronic Records and Signatures (CFR 21 Part 11 Compliance)
Product-Specific Bioequivalence Testing Protocols
Formulation Considerations
Pediatric Pharmaceutical EU Legislation
Pediatric Formulations
SOP and Specification to Establish Electronic Submission to Regulatory Agencies
Part II: Manufacturing Formulations
Part III: Commercial Pharmaceutical Products
