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Items: 1 to 20 of 123

1.

The nonclinical fertility study design for pharmaceuticals.

Lerman SA, Hew KW, Stewart J, Stump DG, Wise LD.

Birth Defects Res B Dev Reprod Toxicol. 2009 Dec;86(6):429-36. doi: 10.1002/bdrb.20221. Review.

PMID:
20025039
2.

Embryo-fetal developmental toxicity study design for pharmaceuticals.

Wise LD, Buschmann J, Feuston MH, Fisher JE, Hew KW, Hoberman AM, Lerman SA, Ooshima Y, Stump DG.

Birth Defects Res B Dev Reprod Toxicol. 2009 Dec;86(6):418-28. doi: 10.1002/bdrb.20214. Review.

PMID:
20025038
3.

Pre- and postnatal developmental toxicity study design for pharmaceuticals.

Bailey GP, Wise LD, Buschmann J, Hurtt M, Fisher JE.

Birth Defects Res B Dev Reprod Toxicol. 2009 Dec;86(6):437-45. doi: 10.1002/bdrb.20217. Review.

PMID:
20025040
4.

Safety and nutritional assessment of GM plants and derived food and feed: the role of animal feeding trials.

EFSA GMO Panel Working Group on Animal Feeding Trials.

Food Chem Toxicol. 2008 Mar;46 Suppl 1:S2-70. doi: 10.1016/j.fct.2008.02.008. Epub 2008 Feb 13. Review.

PMID:
18328408
5.

Introduction to special issue on developmental and reproductive toxicity study designs for pharmaceuticals.

Wise LD.

Birth Defects Res B Dev Reprod Toxicol. 2009 Dec;86(6):417. doi: 10.1002/bdrb.20228. No abstract available.

PMID:
20025037
6.

Reproductive toxicity testing for pharmaceuticals under ICH.

Barrow PC.

Reprod Toxicol. 2009 Sep;28(2):172-9. doi: 10.1016/j.reprotox.2009.03.013. Epub 2009 Apr 9.

PMID:
19631153
7.

Developmental and reproductive toxicology studies in nonhuman primates.

Chellman GJ, Bussiere JL, Makori N, Martin PL, Ooshima Y, Weinbauer GF.

Birth Defects Res B Dev Reprod Toxicol. 2009 Dec;86(6):446-62. doi: 10.1002/bdrb.20216. Review.

PMID:
20025046
9.

Juvenile animal toxicity study designs to support pediatric drug development.

Cappon GD, Bailey GP, Buschmann J, Feuston MH, Fisher JE, Hew KW, Hoberman AM, Ooshima Y, Stump DG, Hurtt ME.

Birth Defects Res B Dev Reprod Toxicol. 2009 Dec;86(6):463-9. doi: 10.1002/bdrb.20220. Review.

PMID:
20025047
10.

Strengths and limitations of using repeat-dose toxicity studies to predict effects on fertility.

Dent MP.

Regul Toxicol Pharmacol. 2007 Aug;48(3):241-58. Epub 2007 Apr 12.

PMID:
17512650
11.

A critical evaluation of developmental and reproductive toxicology in nonhuman primates.

Faqi AS.

Syst Biol Reprod Med. 2012 Feb;58(1):23-32. doi: 10.3109/19396368.2011.648821. Review.

PMID:
22239078
12.

Considerations in assessing the developmental and reproductive toxicity potential of biopharmaceuticals.

Martin PL, Breslin W, Rocca M, Wright D, Cavagnaro J.

Birth Defects Res B Dev Reprod Toxicol. 2009 Jun;86(3):176-203. doi: 10.1002/bdrb.20197. Review.

PMID:
19462404
14.

Reproductive toxicology guidelines: comparison and application.

Beltrame D, Mazué G.

Ann Ist Super Sanita. 1993;29(1):3-14. Review.

PMID:
8129269
15.

A retrospective analysis of the added value of the rat two-generation reproductive toxicity study versus the rat subchronic toxicity study.

Janer G, Hakkert BC, Piersma AH, Vermeire T, Slob W.

Reprod Toxicol. 2007 Jul;24(1):103-13. Epub 2007 May 18.

PMID:
17600672
16.

Collaborative work on evaluation of ovarian toxicity. 5) Two- or four-week repeated-dose studies and fertility study of busulfan in female rats.

Sakurada Y, Kudo S, Iwasaki S, Miyata Y, Nishi M, Masumoto Y.

J Toxicol Sci. 2009;34 Suppl 1:SP65-72.

17.

The ICH S5(R2) guideline for the testing of medicinal agents.

Wise LD.

Methods Mol Biol. 2013;947:1-11. doi: 10.1007/978-1-62703-131-8_1.

PMID:
23138891
18.

Collaborative work on evaluation of ovarian toxicity. 2) Two- or four-week repeated dose studies and fertility study of mifepristone in female rats.

Tamura T, Yokoi R, Okuhara Y, Harada C, Terashima Y, Hayashi M, Nagasawa T, Onozato T, Kobayashi K, Kuroda J, Kusama H.

J Toxicol Sci. 2009;34 Suppl 1:SP31-42.

19.
20.

Some aspects relating to the evaluation of the effects of chemicals on male fertility.

Mangelsdorf I, Buschmann J, Orthen B.

Regul Toxicol Pharmacol. 2003 Jun;37(3):356-69. Review.

PMID:
12758216

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