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Items: 1 to 20 of 81

1.

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
2.

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. Epub 2011 Jun 2. Review.

PMID:
21638754
3.

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. Epub 2011 May 18. Review.

PMID:
21594977
4.

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. Epub 2011 May 18.

PMID:
21594974
5.

What have we learned from pre-clinical juvenile toxicity studies?

Bailey GP, Mariën D.

Reprod Toxicol. 2009 Sep;28(2):226-9. doi: 10.1016/j.reprotox.2009.04.001. Epub 2009 Apr 10.

PMID:
19446432
6.

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
7.

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
8.

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. Epub 2011 May 18. Review.

PMID:
21594978
9.

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
11.

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. Epub 2008 Jun 2.

PMID:
18514481
12.

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. Epub 2011 May 18.

PMID:
21594973
13.

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. Epub 2011 Jul 18. Review.

PMID:
21770023
14.

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. Epub 2011 May 18. Review.

PMID:
21594976
15.

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.

16.

Anticancer Drug Development: The Way Forward.

Connors T.

Oncologist. 1996;1(3):180-181.

17.

Juvenile animal studies for the development of paediatric medicines: a description and conclusions from a European Medicines Agency workshop on juvenile animal testing for nonclinical assessors.

Silva-Lima B, Due Theilade-Thomsen M, Carleer J, Vidal JM, Tomasi P, Saint-Raymond A.

Birth Defects Res B Dev Reprod Toxicol. 2010 Dec;89(6):467-73. doi: 10.1002/bdrb.20257.

PMID:
20632393
18.

Juvenile toxicity: are we asking the right questions?

Downes N.

Toxicol Pathol. 2012 Jul;40(5):830-7. doi: 10.1177/0192623312439124. Epub 2012 Mar 9.

PMID:
22407308
19.

Preclinical pharmacokinetics: an approach towards safer and efficacious drugs.

Singh SS.

Curr Drug Metab. 2006 Feb;7(2):165-82. Review.

PMID:
16472106
20.

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. Epub 2010 Mar 27.

PMID:
20350578

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