Specification of Drug Substances and Drug Products is a fully comprehensive reference on Specification Setting for Pharmaceuticals.
There have been several recent developments in the ICH Guidelines, which were not captured in previous editions, notably the new guideline on Development of Analytical Procedure and the revisions to the validation guidelines, and the specification guidelines.
This edition contains chapters discussing the unique requirements for the universal critical quality attributes, as well as the specific tests required to characterize and control different types of products, ranging in complexity from small molecules in immediate release oral dosage forms to complex products such as drug-antibody conjugates and mRNA-based products.
This substantially expanded revision of the 2nd edition will serve as practical comprehensive reference for scientists, managers, educators, and consultants involved in the development and regulation of pharmaceutical products
1. Chapter 1 : Introduction - p. Page viii 2. Chapter 2 : Principles for setting specifications and shelf lives - p. Page 17 3. Chapter 3 : Stability studies: General regulatory considerations and regional differences - p. Page 44 4. Chapter 4 : Kinetics and mechanisms of drug degradation - p. Page 96 5. Chapter 5 : Analytical procedure life-cycle management - p. Page 124 6. Chapter 6 : Process analytical technology - p. Page 139 7. Chapter 7 : Pharmacopeial methods and tests - p. Page 158 8. Chapter 8 : Development of United States Pharmacopeia-National Formulary (USP–NF) Monographs and General Chapters - p. Page 182 9. Chapter 9 : The distinctiveness of the British Pharmacopoeia and its relationship to other Pharmacopeia - p. Page 202 10. Chapter 10 : Specifications and analytical procedures in registration applications - p. Page 220 11. Chapter 11 : Specifications and analytical procedures in clinical trial applications - p. Page 256 12. Chapter 12 : Description and identification - p. Page 275 13. Chapter 13 : Assay and impurities: Specifications of new chemical entities (“small molecules”) - p. Page 291 14. Chapter 14 : Assay and impurities: Method development as part of analytical life-cycle management - p. Page 329 15. Chapter 15 : Assay and impurities: Method validation - p. Page 371 16. Chapter 16 : Mutagenic impurities - p. Page 400 17. Chapter 17 : Residual solvents - p. Page 417 18. Chapter 18 : Elemental and inorganic impurities - p. Page 437 19. Chapter 19 : Extractables and leachables - p. Page 458 20. Chapter 20 : Microbiology methods - p. Page 473 21. Chapter 21 : Solid-state characterization methods: An overview - p. Page 485 22. Chapter 22 : Solid-state characterization – Method development and validation - p. Page 505 23. Chapter 23 : Chiral methods - p. Page 531 24. Chapter 24 : Water determination - p. Page 554 25. Chapter 25 : Orally administered dosage forms - p. Page 571 26. Chapter 26 : Drug release: Topical products - p. Page 603 27. Chapter 27 : Transdermal products - p. Page 627 28. Chapter 28 : Inhalation products - p. Page 672 29. Chapter 29 : Ophthalmic products - p. Page 697 30. Chapter 30 : General analytical considerations for parenteral products - p. Page 712 31. Chapter 31 : Specification of biotechnology products including cell and gene therapy - p. Page 724 32. Chapter 32 : Biotechnology products: Validation of analytical methods - p. Page 750 33. Chapter 33 : Biosimilars - p. Page 768 34. Chapter 34 : Antibody-drug conjugates - p. Page 781 35. Chapter 35 : Oligonucleotides - p. Page 788 36. Chapter 36 : Specifications for vaccines - p. Page 798 37. Chapter 37 : Nanoparticle suspension dosage forms by nanomilling - p. Page 810 38. Chapter 38 : Development of connected drug delivery systems - p. Page 829 39. Chapter 39 : Bioanalysis of biological matrix samples using liquid chromatography-tandem mass spectrometry detection - p. Page 840 40. Chapter 40 : Bioanalysis of oligonucleotides - p. Page 853 41. Index - p. Page 861
Specification of Drug Substances and Drug Products is a fully comprehensive reference on Specification Setting for Pharmaceuticals.
There have been several recent developments in the ICH Guidelines, which were not captured in previous editions, notably the new guideline on Development of Analytical Procedure and the revisions to the validation guidelines, and the specification guidelines.
This edition contains chapters discussing the unique requirements for the universal critical quality attributes, as well as the specific tests required to characterize and control different types of products, ranging in complexity from small molecules in immediate release oral dosage forms to complex products such as drug-antibody conjugates and mRNA-based products.
This substantially expanded revision of the 2nd edition will serve as practical comprehensive reference for scientists, managers, educators, and consultants involved in the development and regulation of pharmaceutical products
1. Chapter 1 : Introduction - p. Page viii 2. Chapter 2 : Principles for setting specifications and shelf lives - p. Page 17 3. Chapter 3 : Stability studies: General regulatory considerations and regional differences - p. Page 44 4. Chapter 4 : Kinetics and mechanisms of drug degradation - p. Page 96 5. Chapter 5 : Analytical procedure life-cycle management - p. Page 124 6. Chapter 6 : Process analytical technology - p. Page 139 7. Chapter 7 : Pharmacopeial methods and tests - p. Page 158 8. Chapter 8 : Development of United States Pharmacopeia-National Formulary (USP–NF) Monographs and General Chapters - p. Page 182 9. Chapter 9 : The distinctiveness of the British Pharmacopoeia and its relationship to other Pharmacopeia - p. Page 202 10. Chapter 10 : Specifications and analytical procedures in registration applications - p. Page 220 11. Chapter 11 : Specifications and analytical procedures in clinical trial applications - p. Page 256 12. Chapter 12 : Description and identification - p. Page 275 13. Chapter 13 : Assay and impurities: Specifications of new chemical entities (“small molecules”) - p. Page 291 14. Chapter 14 : Assay and impurities: Method development as part of analytical life-cycle management - p. Page 329 15. Chapter 15 : Assay and impurities: Method validation - p. Page 371 16. Chapter 16 : Mutagenic impurities - p. Page 400 17. Chapter 17 : Residual solvents - p. Page 417 18. Chapter 18 : Elemental and inorganic impurities - p. Page 437 19. Chapter 19 : Extractables and leachables - p. Page 458 20. Chapter 20 : Microbiology methods - p. Page 473 21. Chapter 21 : Solid-state characterization methods: An overview - p. Page 485 22. Chapter 22 : Solid-state characterization – Method development and validation - p. Page 505 23. Chapter 23 : Chiral methods - p. Page 531 24. Chapter 24 : Water determination - p. Page 554 25. Chapter 25 : Orally administered dosage forms - p. Page 571 26. Chapter 26 : Drug release: Topical products - p. Page 603 27. Chapter 27 : Transdermal products - p. Page 627 28. Chapter 28 : Inhalation products - p. Page 672 29. Chapter 29 : Ophthalmic products - p. Page 697 30. Chapter 30 : General analytical considerations for parenteral products - p. Page 712 31. Chapter 31 : Specification of biotechnology products including cell and gene therapy - p. Page 724 32. Chapter 32 : Biotechnology products: Validation of analytical methods - p. Page 750 33. Chapter 33 : Biosimilars - p. Page 768 34. Chapter 34 : Antibody-drug conjugates - p. Page 781 35. Chapter 35 : Oligonucleotides - p. Page 788 36. Chapter 36 : Specifications for vaccines - p. Page 798 37. Chapter 37 : Nanoparticle suspension dosage forms by nanomilling - p. Page 810 38. Chapter 38 : Development of connected drug delivery systems - p. Page 829 39. Chapter 39 : Bioanalysis of biological matrix samples using liquid chromatography-tandem mass spectrometry detection - p. Page 840 40. Chapter 40 : Bioanalysis of oligonucleotides - p. Page 853 41. Index - p. Page 861
