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Items: 1 to 20 of 102

1.

Value of juvenile animal studies.

Leconte I, Bailey G, Davis-Bruno K, Hew KW, Kim J, Silva Lima B, Liminga U, Moffit J, De Schaepdrijver L, Schmitt G, Tassinari M, Thompson K, Hurtt M.

Birth Defects Res B Dev Reprod Toxicol. 2011 Aug;92(4):292-303. doi: 10.1002/bdrb.20331. Review.

PMID:
22623020
2.

Juvenile animal studies and pediatric drug development retrospective review: use in regulatory decisions and labeling.

Tassinari MS, Benson K, Elayan I, Espandiari P, Davis-Bruno K.

Birth Defects Res B Dev Reprod Toxicol. 2011 Aug;92(4):261-5. doi: 10.1002/bdrb.20304. Review.

PMID:
21594977
3.

Juvenile animal studies and pediatric drug development: a European regulatory perspective.

Carleer J, Karres J.

Birth Defects Res B Dev Reprod Toxicol. 2011 Aug;92(4):254-60. doi: 10.1002/bdrb.20310. Review.

PMID:
21638754
4.

The value of juvenile animal studies "What have we learned from preclinical juvenile toxicity studies? II".

Bailey GP, Mariën D.

Birth Defects Res B Dev Reprod Toxicol. 2011 Aug;92(4):273-91. doi: 10.1002/bdrb.20328. Review.

PMID:
22623019
5.

The value of juvenile animal studies: a Japanese industry perspective.

Shimomura K.

Birth Defects Res B Dev Reprod Toxicol. 2011 Aug;92(4):266-8. doi: 10.1002/bdrb.20300.

PMID:
21594974
6.

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
7.

Summary of a workshop on nonclinical and clinical immunotoxicity assessment of immunomodulatory drugs.

Piccotti JR, Lebrec HN, Evans E, Herzyk DJ, Hastings KL, Burns-Naas LA, Gourley IS, Wierda D, Kawabata TT.

J Immunotoxicol. 2009 Mar;6(1):1-10. doi: 10.1080/15476910802656440.

PMID:
19519157
8.

Preclinical safety evaluations supporting pediatric drug development with biopharmaceuticals: strategy, challenges, current practices.

Morford LL, Bowman CJ, Blanset DL, Bøgh IB, Chellman GJ, Halpern WG, Weinbauer GF, Coogan TP.

Birth Defects Res B Dev Reprod Toxicol. 2011 Aug;92(4):359-80. doi: 10.1002/bdrb.20305. Review.

PMID:
21770023
9.

Nonclinical support of pediatric drug development in a global context: an industry perspective.

Cappon GD.

Birth Defects Res B Dev Reprod Toxicol. 2011 Aug;92(4):269-72. doi: 10.1002/bdrb.20303. Review.

PMID:
21594976
10.

Comparative juvenile safety testing of new therapeutic candidates: relevance of laboratory animal data to children.

Anderson T, Khan NK, Tassinari MS, Hurtt ME.

J Toxicol Sci. 2009;34 Suppl 2:SP209-15. Review.

11.

Juvenile toxicity: are we asking the right questions?

Downes N.

Toxicol Pathol. 2012 Jul;40(5):830-7. doi: 10.1177/0192623312439124.

PMID:
22407308
12.

The value of juvenile animal studies: a pediatric clinical perspective.

Rose K.

Birth Defects Res B Dev Reprod Toxicol. 2011 Aug;92(4):252-3. doi: 10.1002/bdrb.20306. Review.

PMID:
21594978
13.

Overview: developmental toxicology: new directions.

Shuey D, Kim JH.

Birth Defects Res B Dev Reprod Toxicol. 2011 Oct;92(5):381-3. doi: 10.1002/bdrb.20312.

PMID:
21770024
14.

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. Review.

PMID:
18328408
15.

Juvenile animal testing in drug development--is it useful?

Baldrick P.

Regul Toxicol Pharmacol. 2010 Jul-Aug;57(2-3):291-9. doi: 10.1016/j.yrtph.2010.03.009.

PMID:
20350578
16.

Accelerating the development of 21st-century toxicology: outcome of a Human Toxicology Project Consortium workshop.

Stephens ML, Barrow C, Andersen ME, Boekelheide K, Carmichael PL, Holsapple MP, Lafranconi M.

Toxicol Sci. 2012 Feb;125(2):327-34. doi: 10.1093/toxsci/kfr248.

17.

Juvenile animal studies in the development of pediatric medicines: experience from European medicines and pediatric investigation plans.

Duarte DM, Silva-Lima B.

Birth Defects Res B Dev Reprod Toxicol. 2011 Aug;92(4):353-8. doi: 10.1002/bdrb.20299.

PMID:
21594973
18.

Critical evaluation of current developmental toxicity testing strategies: a case of babies and their bathwater.

Carney EW, Ellis AL, Tyl RW, Foster PM, Scialli AR, Thompson K, Kim J.

Birth Defects Res B Dev Reprod Toxicol. 2011 Oct;92(5):395-403. doi: 10.1002/bdrb.20318. Review.

PMID:
21770028
19.

Proceedings of a workshop on DNA adducts: biological significance and applications to risk assessment Washington, DC, April 13-14, 2004.

Sander M, Cadet J, Casciano DA, Galloway SM, Marnett LJ, Novak RF, Pettit SD, Preston RJ, Skare JA, Williams GM, Van Houten B, Gollapudi BB.

Toxicol Appl Pharmacol. 2005 Oct 1;208(1):1-20.

PMID:
16164957
20.

Real life juvenile toxicity case studies: the good, the bad and the ugly.

De Schaepdrijver L, Rouan MC, Raoof A, Bailey GP, De Zwart L, Monbaliu J, Coogan TP, Lammens L, Coussement W.

Reprod Toxicol. 2008 Sep;26(1):54-5. doi: 10.1016/j.reprotox.2008.04.002.

PMID:
18514481

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