Bowman CJ - Search Results

1

Scientific and Regulatory Policy Committee Points to Consider Review: Inclusion of Reproductive and Pathology End Points for Assessment of Reproductive and Developmental Toxicity in Pharmaceutical Drug Development.

Halpern WG, Ameri M, Bowman CJ, Elwell MR, Mirsky ML, Oliver J, Regan KS, Remick AK, Sutherland VL, Thompson KE, Tremblay C, Yoshida M, Tomlinson L. Halpern WG, et al. Among authors: bowman cj. Toxicol Pathol. 2016 Aug;44(6):789-809. doi: 10.1177/0192623316650052. Epub 2016 May 27. Toxicol Pathol. 2016. PMID: 27235322 Free PMC article.

2

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. Morford LL, et al. Among authors: bowman cj. Birth Defects Res B Dev Reprod Toxicol. 2011 Aug;92(4):359-80. doi: 10.1002/bdrb.20305. Epub 2011 Jul 18. Birth Defects Res B Dev Reprod Toxicol. 2011. PMID: 21770023 Review.

3

Applying a weight of evidence approach to the evaluation of developmental toxicity of biopharmaceuticals.

Rocca M, Morford LL, Blanset DL, Halpern WG, Cavagnaro J, Bowman CJ. Rocca M, et al. Among authors: bowman cj. Regul Toxicol Pharmacol. 2018 Oct;98:69-79. doi: 10.1016/j.yrtph.2018.07.006. Epub 2018 Jul 24. Regul Toxicol Pharmacol. 2018. PMID: 30009863 Review.

4

Science-Based Approach to Harmonize Contraception Recommendations in Clinical Trials and Pharmaceutical Labels.

Bowman CJ, Becourt-Lhote N, Boulifard V, Cordts R, Corriol-Rohou S, Enright B, Erkman L, Harris J, Hartmann A, Hilpert J, Kervyn S, Mattson B, Morford L, Muller M, Powell M, Sobol Z, Srinivasan R, Stark C, Thompson KE, Turner KJ, Barrow P. Bowman CJ, et al. Clin Pharmacol Ther. 2023 Feb;113(2):226-245. doi: 10.1002/cpt.2602. Epub 2022 May 5. Clin Pharmacol Ther. 2023. PMID: 35388453 Free PMC article. Review.

5

Goldilocks' Determination of What New In Vivo Data are "Just Right" for Different Common Drug Development Scenarios, Part 1.

Bowman CJ, Chapin RE. Bowman CJ, et al. Birth Defects Res B Dev Reprod Toxicol. 2016 Aug;107(4-5):185-194. doi: 10.1002/bdrb.21184. Epub 2016 Sep 6. Birth Defects Res B Dev Reprod Toxicol. 2016. PMID: 27601206

6

Juvenile toxicity assessment of anidulafungin in rats: an example of navigating case-by-case study design through scientific and regulatory challenges.

Bowman CJ, Chmielewski G, Lewis E, Ripp S, Sawaryn CM, Cross DM. Bowman CJ, et al. Birth Defects Res B Dev Reprod Toxicol. 2011 Aug;92(4):333-44. doi: 10.1002/bdrb.20301. Epub 2011 May 18. Birth Defects Res B Dev Reprod Toxicol. 2011. PMID: 21594975

7

Non-clinical safety assessment and toxicokinetics of voriconazole and anidulafungin in the juvenile rat: a combination study design in support of a Paediatric Investigation Plan.

Cross DM, Chmielewski G, Lewis EM, Liu L, Modesitt MS, Ripp SL, Sawaryn CM, Bowman CJ. Cross DM, et al. Among authors: bowman cj. Regul Toxicol Pharmacol. 2012 Jun;63(1):29-39. doi: 10.1016/j.yrtph.2012.02.004. Epub 2012 Feb 16. Regul Toxicol Pharmacol. 2012. PMID: 22343256

8

Developmental toxicity study of lersivirine in mice.

Cappon GD, Bowman CJ, Campion SN, Chmielewski G, Hurtt ME, Finch GL, Lewis EM. Cappon GD, et al. Among authors: bowman cj. Birth Defects Res B Dev Reprod Toxicol. 2012 Jun;95(3):225-30. doi: 10.1002/bdrb.21008. Epub 2012 Mar 22. Birth Defects Res B Dev Reprod Toxicol. 2012. PMID: 22447726

9

Decreased maternal and fetal cholesterol following maternal bococizumab (anti-PCSK9 monoclonal antibody) administration does not affect rat embryo-fetal development.

Campion SN, Han B, Cappon GD, Lewis EM, Kraynov E, Liang H, Bowman CJ. Campion SN, et al. Among authors: bowman cj. Regul Toxicol Pharmacol. 2015 Nov;73(2):562-70. doi: 10.1016/j.yrtph.2015.08.007. Epub 2015 Sep 14. Regul Toxicol Pharmacol. 2015. PMID: 26382609

10

Reproductive and developmental toxicity assessment of palbociclib, a CDK4/6 inhibitor, in Sprague-Dawley rats and New Zealand White rabbits.

Catlin NR, Bowman CJ, Engel SM, Sacaan A, Thibault S, Lewis EM, Cappon GD. Catlin NR, et al. Among authors: bowman cj. Reprod Toxicol. 2019 Sep;88:76-84. doi: 10.1016/j.reprotox.2019.07.016. Epub 2019 Jul 27. Reprod Toxicol. 2019. PMID: 31362042

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