These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
150 related articles for article (PubMed ID: 10365470)
1. [ICH M4: the standardized international restration dossier or "C.T.D." (common technical document)]. de Cremiers F Ann Pharm Fr; 1999 Mar; 57(2):143-6. PubMed ID: 10365470 [TBL] [Abstract][Full Text] [Related]
2. [Objectives and organization of the International Conference on Harmonization]. Juillet Y Ann Pharm Fr; 1999 Mar; 57(2):137-42. PubMed ID: 10365469 [TBL] [Abstract][Full Text] [Related]
3. Industry perspectives on ICH guidelines. Rockhold FW Stat Med; 2002 Oct; 21(19):2949-57. PubMed ID: 12325111 [TBL] [Abstract][Full Text] [Related]
4. [Contribution of explanatory notes. Efficacy of the ICH plan for international clinical development of a new drug]. Husson JM Ann Pharm Fr; 1999 Mar; 57(2):153-60. PubMed ID: 10365472 [TBL] [Abstract][Full Text] [Related]
5. Statistical concepts in the planning and evaluation of drug safety from clinical trials in drug development: issues of international harmonization. O'Neill RT Stat Med; 1995 May 15-30; 14(9-10):117-27. PubMed ID: 7569506 [TBL] [Abstract][Full Text] [Related]
6. The Investigators' Brochure: a comparison of the draft international conference on harmonisation guideline with current Food and Drug Administration requirements. Cocchetto DM Qual Assur; 1995 Dec; 4(4):240-6. PubMed ID: 8890349 [TBL] [Abstract][Full Text] [Related]
7. Characterization and establishment of specifications for biopharmaceuticals. Davis GC; Riggin RM Dev Biol Stand; 1997; 91():49-54. PubMed ID: 9413683 [TBL] [Abstract][Full Text] [Related]
8. International Conference on Harmonisation; S10 Photosafety Evaluation of Pharmaceuticals; guidance for industry; availability. Notice. Food and Drug Administration, HHS Fed Regist; 2015 Jan; 80(17):4282-3. PubMed ID: 25730921 [TBL] [Abstract][Full Text] [Related]
9. International Conference on Harmonisation; guidance on M4 common technical document; availability. Notice. Food and Drug Administration, HHS Fed Regist; 2001 Oct; 66(200):52634-7. PubMed ID: 12358037 [TBL] [Abstract][Full Text] [Related]
10. [Pharmaceutical product quality control and good manufacturing practices]. Hiyama Y Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku; 2010; (128):1-16. PubMed ID: 21381389 [TBL] [Abstract][Full Text] [Related]
11. The NCI All Ireland Cancer Conference. Johnston PG; Daly PA; Liu E Oncologist; 1999; 4(4):275-277. PubMed ID: 10545862 [TBL] [Abstract][Full Text] [Related]
12. Stability testing requirements for vaccines--draft guidelines of the International Conference on Harmonization. Haase M Dev Biol Stand; 1996; 87():309-18. PubMed ID: 8854031 [TBL] [Abstract][Full Text] [Related]
13. WHO Expert Committee on Specifications for Pharmaceutical Preparations. World Health Organization World Health Organ Tech Rep Ser; 2011; (961):1-428, back cover. PubMed ID: 21699061 [TBL] [Abstract][Full Text] [Related]
14. International Conference on Harmonisation; guidance on electronic common technical document specification; availability. Notice. Food and Drug Administration, HHS Fed Regist; 2003 Apr; 68(63):16060-1. PubMed ID: 12674113 [TBL] [Abstract][Full Text] [Related]
15. Internationalization of regulatory requirements. Juillet Y Fundam Clin Pharmacol; 2003 Feb; 17(1):21-5. PubMed ID: 12588627 [TBL] [Abstract][Full Text] [Related]
16. The International Conference on Harmonization common technical document--global submission format? Molzon JA Food Drug Law J; 2005; 60(3):447-51. PubMed ID: 16304749 [No Abstract] [Full Text] [Related]
17. WHO Expert Committee on Specifications for Pharmaceutical Preparations. World Health Organ Tech Rep Ser; 1999; 885():i-vi, 1-156. PubMed ID: 10352573 [TBL] [Abstract][Full Text] [Related]
18. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty-first report. World Health Organization World Health Organ Tech Rep Ser; 2007; (943):1-156. PubMed ID: 17621973 [TBL] [Abstract][Full Text] [Related]
19. International Conference on Harmonisation; guidance on Q10 Pharmaceutical Quality System; availability. Notice. Food and Drug Administration, HHS Fed Regist; 2009 Apr; 74(66):15990-1. PubMed ID: 19507321 [TBL] [Abstract][Full Text] [Related]
20. WHO Expert Committee on Specifications for Pharmaceutical Preparations. World Health Organ Tech Rep Ser; 2003; 917():i-viii, 1-125, back cover. PubMed ID: 15024913 [TBL] [Abstract][Full Text] [Related] [Next] [New Search]