Specification of Drug Substances and Products
Specification of Drug Substances and Products
Development and Validation of Analytical Methods
Riley, Christopher M. (President of Riley and Rabel Consulting Services, Maryville, MO, USA); Rosanske, Thomas W. (Consultatnt, Lee's Summit, MO, USA); Reid, George L. (Principal Consultant, Cardinal Health, Kansas City, MO, USA)
Elsevier Health Sciences
12/2019
712
Mole
Inglês
9780081028247
Descrição não disponível.
PART 1 INTRODUCTION 1. Introduction 2. General Principles and Regulatory Considerations: Specifications and Shelf Life Setting 3. Application of Quality by Design (QbD) to the Development and Validation of Analytical Methods 4. General Principles and Regulatory Considerations: Method Development and Validation 5. Analytical Methods in the Clinical Phase of Development 6. Method Transfer 7. Process Analytical Technology 8. Analytical Procedure Life Cycle Management 9. Challenges of Analytics in Generic Products PART 2 UNIVERSAL TESTS 10. Description and Identification 11. Assay and Impurities 12. Genotoxic Impurities 13. Residual Solvents 14. Inorganic Impurities (Elemental Impurities) PART 3 SPECIFIC TESTS: DRUG SUBSTANCES 15. Solid State Characterization 16. Chiral Methods 17. Water Determination PART 4 SPECIFIC TESTS DRUG PRODUCT 18. Drug Release: Oral Products 19. Topical Products 20. Nasal Sprays and Inhalation Products 21. Extractables and Leachables PART 5 BIOTECHNOLOGY PRODUCTS 22. Regulatory Requirements for Setting Specifications 23. Specifications for Drug Substance 24. Specifications for Drug Product 25. Validation of Analytical Methods 26. Complex Biological Products PART 6 PHARMACOPEIAL METHODS 27. Pharmacopeial Methods and Test PART 7 BIOLOGICAL FLUIDS 28. Biological Fluids PART 8 STERILE PRODUCTS 29. Microbial Methods and Endotoxin Testing
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PART 1 INTRODUCTION 1. Introduction 2. General Principles and Regulatory Considerations: Specifications and Shelf Life Setting 3. Application of Quality by Design (QbD) to the Development and Validation of Analytical Methods 4. General Principles and Regulatory Considerations: Method Development and Validation 5. Analytical Methods in the Clinical Phase of Development 6. Method Transfer 7. Process Analytical Technology 8. Analytical Procedure Life Cycle Management 9. Challenges of Analytics in Generic Products PART 2 UNIVERSAL TESTS 10. Description and Identification 11. Assay and Impurities 12. Genotoxic Impurities 13. Residual Solvents 14. Inorganic Impurities (Elemental Impurities) PART 3 SPECIFIC TESTS: DRUG SUBSTANCES 15. Solid State Characterization 16. Chiral Methods 17. Water Determination PART 4 SPECIFIC TESTS DRUG PRODUCT 18. Drug Release: Oral Products 19. Topical Products 20. Nasal Sprays and Inhalation Products 21. Extractables and Leachables PART 5 BIOTECHNOLOGY PRODUCTS 22. Regulatory Requirements for Setting Specifications 23. Specifications for Drug Substance 24. Specifications for Drug Product 25. Validation of Analytical Methods 26. Complex Biological Products PART 6 PHARMACOPEIAL METHODS 27. Pharmacopeial Methods and Test PART 7 BIOLOGICAL FLUIDS 28. Biological Fluids PART 8 STERILE PRODUCTS 29. Microbial Methods and Endotoxin Testing
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
