International Pharmaceutical Product Registration

ISBN-13: 9781420081763 / Angielski / Twarda / 2009 / 852 str.

Tony Cartwright; Brian Matthews

Opis

Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.

The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.

This cutting-edge resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission. The format, specification, and technical requirements of the e-CTD, the electronic version of CTD, are also thoroughly discussed.

This text is a must-have for those in the pharmaceutical industry determining regulatory requirements for the major world markets in Europe, the US, Canada, and Japan.

Spis treści

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.

O autorze

Brian R. Matthews, Anthony C. Cartwright