Leighton JK - Search Results

1

An FDA analysis of clinical hold deficiencies affecting investigational new drug applications for oncology products.

Manning ML, Thompson MD, Saber H, Maher VE, Crich JZ, Leighton JK. Manning ML, et al. Among authors: leighton jk. Regul Toxicol Pharmacol. 2020 Feb;110:104511. doi: 10.1016/j.yrtph.2019.104511. Epub 2019 Oct 31. Regul Toxicol Pharmacol. 2020. PMID: 31678263

2

Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: report of the first FDA-PWG-PhRMA-DruSafe Workshop.

Lesko LJ, Salerno RA, Spear BB, Anderson DC, Anderson T, Brazell C, Collins J, Dorner A, Essayan D, Gomez-Mancilla B, Hackett J, Huang SM, Ide S, Killinger J, Leighton J, Mansfield E, Meyer R, Ryan SG, Schmith V, Shaw P, Sistare F, Watson M, Worobec A. Lesko LJ, et al. J Clin Pharmacol. 2003 Apr;43(4):342-58. doi: 10.1177/0091270003252244. J Clin Pharmacol. 2003. PMID: 12723455

3

Nonclinical aspects of biopharmaceutical development: discussion of case studies at a PhRMA-FDA workshop.

Buckley LA, Benson K, Davis-Bruno K, Dempster M, Finch GL, Harlow P, Haggerty HG, Hart T, Kinter L, Leighton JK, McNulty J, Roskos L, Saber H, Stauber A, Tabrizi M. Buckley LA, et al. Among authors: leighton jk. Int J Toxicol. 2008 Jul-Aug;27(4):303-12. doi: 10.1080/10915810802367016. Int J Toxicol. 2008. PMID: 18821393

4

Qualification of cardiac troponins for nonclinical use: a regulatory perspective.

Hausner EA, Hicks KA, Leighton JK, Szarfman A, Thompson AM, Harlow P. Hausner EA, et al. Among authors: leighton jk. Regul Toxicol Pharmacol. 2013 Oct;67(1):108-14. doi: 10.1016/j.yrtph.2013.07.006. Epub 2013 Jul 20. Regul Toxicol Pharmacol. 2013. PMID: 23876748 Review.

5

Enzalutamide for treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel: U.S. Food and Drug Administration drug approval summary.

Ning YM, Pierce W, Maher VE, Karuri S, Tang SH, Chiu HJ, Palmby T, Zirkelbach JF, Marathe D, Mehrotra N, Liu Q, Ghosh D, Cottrell CL, Leighton J, Sridhara R, Ibrahim A, Justice R, Pazdur R. Ning YM, et al. Clin Cancer Res. 2013 Nov 15;19(22):6067-73. doi: 10.1158/1078-0432.CCR-13-1763. Epub 2013 Oct 18. Clin Cancer Res. 2013. PMID: 24141628

6

An FDA oncology analysis of antibody-drug conjugates.

Saber H, Leighton JK. Saber H, et al. Among authors: leighton jk. Regul Toxicol Pharmacol. 2015 Apr;71(3):444-52. doi: 10.1016/j.yrtph.2015.01.014. Epub 2015 Feb 7. Regul Toxicol Pharmacol. 2015. PMID: 25661711

7

An FDA oncology view of juvenile animal studies in support of initial pediatric trials for anticancer drugs.

Leighton JK, Saber H, Reaman G, Pazdur R. Leighton JK, et al. Regul Toxicol Pharmacol. 2016 Aug;79:142-143. doi: 10.1016/j.yrtph.2016.03.001. Epub 2016 Mar 4. Regul Toxicol Pharmacol. 2016. PMID: 26952647 No abstract available.

8

An FDA oncology analysis of immune activating products and first-in-human dose selection.

Saber H, Gudi R, Manning M, Wearne E, Leighton JK. Saber H, et al. Among authors: leighton jk. Regul Toxicol Pharmacol. 2016 Nov;81:448-456. doi: 10.1016/j.yrtph.2016.10.002. Epub 2016 Oct 13. Regul Toxicol Pharmacol. 2016. PMID: 27743776

9

An FDA oncology analysis of CD3 bispecific constructs and first-in-human dose selection.

Saber H, Del Valle P, Ricks TK, Leighton JK. Saber H, et al. Among authors: leighton jk. Regul Toxicol Pharmacol. 2017 Nov;90:144-152. doi: 10.1016/j.yrtph.2017.09.001. Epub 2017 Sep 5. Regul Toxicol Pharmacol. 2017. PMID: 28887049 Review.

10

An FDA oncology analysis of toxicities associated with PBD-containing antibody-drug conjugates.

Saber H, Simpson N, Ricks TK, Leighton JK. Saber H, et al. Among authors: leighton jk. Regul Toxicol Pharmacol. 2019 Oct;107:104429. doi: 10.1016/j.yrtph.2019.104429. Epub 2019 Jul 17. Regul Toxicol Pharmacol. 2019. PMID: 31325532

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