International Pharmaceutical Product Registration

Part 1: General Topics. 1. The Common Technical Document – a global format for registration files. 2. The electronic CTD (e-CTD). 3. Module 1 of the CTD. 4. Environmental risk assessment. Part 2: CTD Summaries. 5. The Quality Overall Summary. 6. The Nonclinical Overview and Summary. 7. The Clinical Overview and Summary. Part 3: Quality Topics. 8. Drug Substance – General Information. 9. Drug Substance Manufacture. 10. Drug Substance Characterisation. 11. Control of Drug Substance. 12. Drug Substance and Drug Product – Container/Closure. 13. Drug Product – Description and Composition. 14. Drug Product – Pharmaceutical Development. 15. Drug Product – Manufacture and Process Validation. 16. Drug Product - Excipients. 17. Control of Drug Product. 18. Reference Standards or Materials. 19. Drug Substance and Drug Product Stability. 20. Viral and TSE Requirements. 21. Pharmaceutical Quality Systems. Part 4: Nonclinical. 22. Nonclinical Testing Strategy. 23. Pharmacology. 24. Pharmacokinetics and Toxicokinetics. 25. Single and repeat dose toxicity. 26. Genotoxicity. 27. Carcinogenicity. 28. Reproductive and Development Toxicity. 29. Safety pharmacology. 30. Phototoxicity. 31. Immunotoxicology. 32. Local tolerance and other toxicity studies. Part 5: Clinical Topics. 33. Bioavailability and Bioequivalence Studies. 34. Pharmacokinetics. 35. Pharmacodynamics. 36. Biostatistics: Design and Analysis of Clinical Studies. 37. Efficacy and Safety Clinical Studies. 38. Post-marketing evaluation. 39. Pharmacovigilance and risk management. 40. Studies in pregnancy and children. 41. Studies in the elderly. 42. Good Clinical Practice. 43. Prevention and detection of fraud in clinical trials. Other Topics. 44. Biological and Biotechnology Products. 45. Device Drug Combination Products. 46. Nonclinical safety assessment of nanomedicines. 47. Modelling and medical product R&D. Other. Annex 1: List of acronyms and abbreviations. Annex 2: List of key technical and regulatory information sources – published information, websites etc.

Biography

Brian R. Matthews, Anthony C. Cartwright

'... the book is a must-have for all experts working in the area of R&D, in particular pharmaceutical development, toxicology, pharmacology, clinical development and, of course, regulatory affairs.

It will help to avoid mistakes that may lead to delays in submission of applications or deficiency letters that are received as a surprise by the applicants. In other words, to provide patients with medicines earlier, you had better have the book available next to your desk.'

'...the book does provide a very good overview of all aspects of the drug registration requirements and deserves a place in every pharmaceutical library.' The British Toxicology Society Newsletter