126 related articles for article (PubMed ID: 8812971)
1. New guidelines for preclinical testing of novel medicines for their effects on reproduction: clarity or confusion?
Sutherland MF
Regul Toxicol Pharmacol; 1996 Jun; 23(3):300-3. PubMed ID: 8812971
[No Abstract] [Full Text] [Related]
2. The presence of drug in control samples during toxicokinetic investigations--a Novartis perspective.
Nicholls I; Kolopp M; Pommier F; Scheiwiller M
Regul Toxicol Pharmacol; 2005 Jul; 42(2):172-8. PubMed ID: 15885865
[TBL] [Abstract][Full Text] [Related]
3. Food and Drug Administration proposed testing guidelines for reproduction studies. Revision Committee. FDA Guidelines for Developmental Toxicity and Reproduction, Food and Drug Administration.
Collins TF; Sprando RL; Shackelford ME; Hansen DK; Welsh JJ
Regul Toxicol Pharmacol; 1999 Aug; 30(1):29-38. PubMed ID: 10464044
[TBL] [Abstract][Full Text] [Related]
4. Alternative strategies for toxicity testing of species-specific biopharmaceuticals.
Bussiere JL; Martin P; Horner M; Couch J; Flaherty M; Andrews L; Beyer J; Horvath C
Int J Toxicol; 2009; 28(3):230-53. PubMed ID: 19546261
[TBL] [Abstract][Full Text] [Related]
5. Recommendations to guide determining cause of death in toxicity studies.
Long G
Toxicol Pathol; 2004; 32(2):269-70. PubMed ID: 15200167
[No Abstract] [Full Text] [Related]
6. The OECD guidelines for the testing of chemicals and pesticides.
Buschmann J
Methods Mol Biol; 2013; 947():37-56. PubMed ID: 23138894
[TBL] [Abstract][Full Text] [Related]
7. STP position paper: best practice guideline for the routine pathology evaluation of the immune system.
Haley P; Perry R; Ennulat D; Frame S; Johnson C; Lapointe JM; Nyska A; Snyder P; Walker D; Walter G;
Toxicol Pathol; 2005; 33(3):404-7; discussion 408. PubMed ID: 15805080
[No Abstract] [Full Text] [Related]
8. 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]
9. Nonclinical reproductive toxicity testing requirements for drugs, pesticides, and industrial chemicals in India and China.
Rao KS; Dong J
Methods Mol Biol; 2013; 947():13-30. PubMed ID: 23138892
[TBL] [Abstract][Full Text] [Related]
10. Revision of the ICH guideline on detection of toxicity to reproduction for medicinal products: SWOT analysis.
Barrow P
Reprod Toxicol; 2016 Sep; 64():57-63. PubMed ID: 27046733
[TBL] [Abstract][Full Text] [Related]
11. The developmental toxicity testing of biologics.
Hazelden KP
Methods Mol Biol; 2013; 947():31-6. PubMed ID: 23138893
[TBL] [Abstract][Full Text] [Related]
12. The ICH S5(R2) guideline for the testing of medicinal agents.
Wise LD
Methods Mol Biol; 2013; 947():1-11. PubMed ID: 23138891
[TBL] [Abstract][Full Text] [Related]
13. Immune assessments in developmental and juvenile toxicology: practical considerations for the regulatory safety testing of pharmaceuticals.
Barrow PC; Ravel G
Regul Toxicol Pharmacol; 2005 Oct; 43(1):35-44. PubMed ID: 16099567
[TBL] [Abstract][Full Text] [Related]
14. Reproductive toxicity testing for pharmaceuticals under ICH.
Barrow PC
Reprod Toxicol; 2009 Sep; 28(2):172-9. PubMed ID: 19631153
[TBL] [Abstract][Full Text] [Related]
15. Food and Drug Administration proposed testing guidelines for developmental toxicity studies. Revision Committee. FDA Guidelines for Developmental Toxicity and Reproduction, Food and Drug Administration.
Collins TF; Sprando RL; Shackelford ME; Hansen DK; Welsh JJ
Regul Toxicol Pharmacol; 1999 Aug; 30(1):39-44. PubMed ID: 10464045
[TBL] [Abstract][Full Text] [Related]
16. Preclinical predictors of clinical safety: opportunities for improvement.
Sistare FD; DeGeorge JJ
Clin Pharmacol Ther; 2007 Aug; 82(2):210-4. PubMed ID: 17507920
[TBL] [Abstract][Full Text] [Related]
17. Use and abuse of QT and TRIaD in cardiac safety research: importance of study design and conduct.
Hondeghem LM
Eur J Pharmacol; 2008 Apr; 584(1):1-9. PubMed ID: 18304526
[TBL] [Abstract][Full Text] [Related]
18. SIDS reprotoxicity screening test update: testing strategies and use.
Gelbke HP; Fleig H; Meder M;
Regul Toxicol Pharmacol; 2004 Apr; 39(2):81-6. PubMed ID: 15041141
[TBL] [Abstract][Full Text] [Related]
19. Critical aspects in reproductive and developmental toxicity testing of environmental chemicals.
Buschmann J
Reprod Toxicol; 2006 Aug; 22(2):157-63. PubMed ID: 16782303
[TBL] [Abstract][Full Text] [Related]
20. Toxicology testing in drug discovery and development.
Dorato MA; Buckley LA
Curr Protoc Toxicol; 2007 Feb; Chapter 19():Unit19.1. PubMed ID: 23045141
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]