238 related articles for article (PubMed ID: 21770023)
1. 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. PubMed ID: 21770023
[TBL] [Abstract][Full Text] [Related]
2. 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. PubMed ID: 21594976
[TBL] [Abstract][Full Text] [Related]
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. PubMed ID: 21594977
[TBL] [Abstract][Full Text] [Related]
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. PubMed ID: 21594974
[TBL] [Abstract][Full Text] [Related]
5. 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. PubMed ID: 21638754
[TBL] [Abstract][Full Text] [Related]
6. 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. PubMed ID: 21594973
[TBL] [Abstract][Full Text] [Related]
7. 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. PubMed ID: 21594978
[TBL] [Abstract][Full Text] [Related]
8. 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. PubMed ID: 22623019
[TBL] [Abstract][Full Text] [Related]
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. PubMed ID: 20025047
[TBL] [Abstract][Full Text] [Related]
10. 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. PubMed ID: 22623020
[TBL] [Abstract][Full Text] [Related]
11. Pediatric cardiovascular safety: challenges in drug and device development and clinical application.
Bates KE; Vetter VL; Li JS; Cummins S; Aguel F; Almond C; Dubin AM; Elia J; Finkle J; Hausner EA; Joseph F; Karkowsky AM; Killeen M; Lemacks J; Mathis L; McMahon AW; Pinnow E; Rodriguez I; Stockbridge NL; Stockwell M; Tassinari M; Krucoff MW
Am Heart J; 2012 Oct; 164(4):481-92. PubMed ID: 23067905
[TBL] [Abstract][Full Text] [Related]
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. PubMed ID: 19462404
[TBL] [Abstract][Full Text] [Related]
13. Juvenile animal testing in drug development--is it useful?
Baldrick P
Regul Toxicol Pharmacol; 2010; 57(2-3):291-9. PubMed ID: 20350578
[TBL] [Abstract][Full Text] [Related]
14. 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]
15. The economics of pediatric formulation development for off-patent drugs.
Milne CP; Bruss JB
Clin Ther; 2008 Nov; 30(11):2133-45. PubMed ID: 19108801
[TBL] [Abstract][Full Text] [Related]
16. 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. PubMed ID: 18328408
[TBL] [Abstract][Full Text] [Related]
17. Drug development process for a product with a primary pediatric indication.
Allen AJ; Michelson D
J Clin Psychiatry; 2002; 63 Suppl 12():44-9. PubMed ID: 12562061
[TBL] [Abstract][Full Text] [Related]
18. Overview of the nonclinical quality and toxicology testing for recombinant biopharmaceuticals produced in mammalian cells.
Lebrec H; Narayanan P; Nims R
J Appl Toxicol; 2010 Jul; 30(5):387-96. PubMed ID: 20589744
[TBL] [Abstract][Full Text] [Related]
19. Thirty years of preclinical safety evaluation of biopharmaceuticals: Did scientific progress lead to appropriate regulatory guidance?
Kooijman M; van Meer PJ; Moors EH; Schellekens H
Expert Opin Drug Saf; 2012 Sep; 11(5):797-801. PubMed ID: 22861668
[TBL] [Abstract][Full Text] [Related]
20. The application of ICH S6 to the preclinical safety evaluation of plasma derivative therapeutic products.
Lewis RM; Cavagnaro J
Biologicals; 2010 Jul; 38(4):494-500. PubMed ID: 20359910
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
