642 related articles for article (PubMed ID: 8890349)
1. 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]
2. 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]
3. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2008 Feb; 73(35):9575-6. PubMed ID: 18677819
[TBL] [Abstract][Full Text] [Related]
4. 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]
5. International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); final guidance for industry on "studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing" (VICH GL23); availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2002 Jan; 67(3):602-3. PubMed ID: 12358039
[TBL] [Abstract][Full Text] [Related]
6. International Conference on Harmonisation; draft guidance on E2F Development Safety Update Report; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2008 Aug; 73(151):45462-3. PubMed ID: 18949880
[TBL] [Abstract][Full Text] [Related]
7. International Cooperation on Harmonisation of Technical requirements for Approval of Veterinary Medicinal Products (VICH); final guidance on " Safety studies for veterinary drug residues in human food: reproduction toxicity testing" (VICH GL22); availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2002 Jan; 67(3):603-5. PubMed ID: 12365425
[TBL] [Abstract][Full Text] [Related]
8. International Conference on Harmonisation; choice of control group and related issues in clinical trials; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2001 May; 66(93):24390-1. PubMed ID: 12356096
[TBL] [Abstract][Full Text] [Related]
9. International Conference on Harmonisation; Guidance on Q8 Pharmaceutical Development; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2006 May; 71(98):29344-5. PubMed ID: 16749216
[TBL] [Abstract][Full Text] [Related]
10. International Conference on Harmonisation: guidance on testing for carcinogenicity of pharmaceuticals. Notice. Food and Drug Administration, HHS.
Fed Regist; 1998 Feb; 63(35):8983-6. PubMed ID: 12269370
[TBL] [Abstract][Full Text] [Related]
11. International Conference on Harmonisation; guidance on Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2004 Feb; 69(24):5551-2. PubMed ID: 14968802
[TBL] [Abstract][Full Text] [Related]
12. International Conference on Harmonisation; draft guidance on specifications: test procedures and acceptance criteria for biotechnological/biological products--FDA. Notice.
Fed Regist; 1998 Jun; 63(110):31506-13. PubMed ID: 10180131
[TBL] [Abstract][Full Text] [Related]
13. Industry perspectives on ICH guidelines.
Rockhold FW
Stat Med; 2002 Oct; 21(19):2949-57. PubMed ID: 12325111
[TBL] [Abstract][Full Text] [Related]
14. International Conference on Harmonisation; guidance on S7A safety pharmacology studies for human pharmaceuticals; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2001 Jul; 66(135):36791-2. PubMed ID: 12356097
[TBL] [Abstract][Full Text] [Related]
15. International Conference on Harmonisation; revised guidance on Q3A impurities in new drug substances; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2003 Feb; 68(28):6924-5. PubMed ID: 12583358
[TBL] [Abstract][Full Text] [Related]
16. International Conference on Harmonisation; guidance on E11 clinical investigation of medicinal products in the pediatric population; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2000 Dec; 65(242):78493-4. PubMed ID: 12362934
[TBL] [Abstract][Full Text] [Related]
17. International Conference on Harmonisation: guidance on Q1D bracketing and matrixing designs for stability testing of new drug substances and products; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2003 Jan; 68(11):2339-40. PubMed ID: 12532979
[TBL] [Abstract][Full Text] [Related]
18. International Conference on Harmonisation; guidance on good manufacturing practice for active pharmaceutical ingredients; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2001 Sep; 66(186):49028-9. PubMed ID: 12358036
[TBL] [Abstract][Full Text] [Related]
19. International Conference on Harmonisation; guidance on specifications: test procedures and acceptance criteria for biotechnological/biological products. Notice. Food and Drug Administration, HHS.
Fed Regist; 1999 Aug; 64(159):44928-35. PubMed ID: 12356094
[TBL] [Abstract][Full Text] [Related]
20. International Conference on Harmonisation; guidance on Q1A stability testing of new drug substances and products; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2001 Nov; 66(216):56332-3. PubMed ID: 12358038
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
