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Items: 23

1.

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

Saber H, Del Valle P, Ricks TK, Leighton JK.

Regul Toxicol Pharmacol. 2017 Nov;90:144-152. doi: 10.1016/j.yrtph.2017.09.001. Epub 2017 Sep 5. Review.

PMID:
28887049
2.

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

Saber H, Gudi R, Manning M, Wearne E, Leighton JK.

Regul Toxicol Pharmacol. 2016 Nov;81:448-456. doi: 10.1016/j.yrtph.2016.10.002. Epub 2016 Oct 13.

PMID:
27743776
3.

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.

Regul Toxicol Pharmacol. 2016 Aug;79:142-143. doi: 10.1016/j.yrtph.2016.03.001. Epub 2016 Mar 4. No abstract available.

PMID:
26952647
4.

An FDA oncology analysis of antibody-drug conjugates.

Saber H, Leighton JK.

Regul Toxicol Pharmacol. 2015 Apr;71(3):444-52. doi: 10.1016/j.yrtph.2015.01.014. Epub 2015 Feb 7.

PMID:
25661711
5.

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

Hausner EA, Hicks KA, Leighton JK, Szarfman A, Thompson AM, Harlow P.

Regul Toxicol Pharmacol. 2013 Oct;67(1):108-14. doi: 10.1016/j.yrtph.2013.07.006. Epub 2013 Jul 20. Review.

PMID:
23876748
6.

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.

Int J Toxicol. 2008 Jul-Aug;27(4):303-12. doi: 10.1080/10915810802367016.

PMID:
18821393
7.

Tasigna for chronic and accelerated phase Philadelphia chromosome--positive chronic myelogenous leukemia resistant to or intolerant of imatinib.

Hazarika M, Jiang X, Liu Q, Lee SL, Ramchandani R, Garnett C, Orr MS, Sridhara R, Booth B, Leighton JK, Timmer W, Harapanhalli R, Dagher R, Justice R, Pazdur R.

Clin Cancer Res. 2008 Sep 1;14(17):5325-31. doi: 10.1158/1078-0432.CCR-08-0308.

8.

Workgroup report: Review of genomics data based on experience with mock submissions--view of the CDER Pharmacology Toxicology Nonclinical Pharmacogenomics Subcommittee.

Leighton JK, Brown P, Ellis A, Harlow P, Harrouk W, Pine PS, Robison T, Rosario L, Thompson K.

Environ Health Perspect. 2006 Apr;114(4):573-8. Review.

9.

Application of emerging technologies in toxicology and safety assessment: regulatory perspectives.

Leighton JK.

Int J Toxicol. 2005 May-Jun;24(3):153-5. Review.

PMID:
16040567
10.

Approval summary: azacitidine for treatment of myelodysplastic syndrome subtypes.

Kaminskas E, Farrell A, Abraham S, Baird A, Hsieh LS, Lee SL, Leighton JK, Patel H, Rahman A, Sridhara R, Wang YC, Pazdur R; FDA.

Clin Cancer Res. 2005 May 15;11(10):3604-8.

11.

Pharmacogenomic data submissions to the FDA: non-clinical case studies.

Leighton JK, DeGeorge J, Jacobson-Kram D, MacGregor J, Mendrick D, Worobec A.

Pharmacogenomics. 2004 Jul;5(5):507-11. No abstract available.

PMID:
15212587
12.

Center for Veterinary Medicine's perspective on the beef hormone case.

Leighton JK.

Vet Clin North Am Food Anim Pract. 1999 Mar;15(1):167-80, x. Review.

PMID:
10088217
13.

Expression of cytochrome P450 1A1, an estrogen hydroxylase, in ovarian granulosa cells is developmentally regulated.

Leighton JK, Canning S, Guthrie HD, Hammond JM.

J Steroid Biochem Mol Biol. 1995 Apr;52(4):351-6.

PMID:
7734403
14.

IGF-binding proteins are differentially regulated in an ovarian granulosa cell line.

Leighton JK, Grimes RW, Canning SF, Hammond JM.

Mol Cell Endocrinol. 1994 Dec;106(1-2):75-80.

PMID:
7534734
15.
16.

Expression of the IGF system in primary and immortalized porcine ovarian granulosa cells.

Leighton JK, Grimes RW, Canning S, Hammond JM.

Mol Cell Endocrinol. 1993 Nov;97(1-2):29-35.

PMID:
8143903
20.

Nucleotide sequence of the rat low density lipoprotein receptor cDNA.

Lee LY, Mohler WA, Schafer BL, Freudenberger JS, Byrne-Connolly N, Eager KB, Mosley ST, Leighton JK, Thrift RN, Davis RA, et al.

Nucleic Acids Res. 1989 Feb 11;17(3):1259-60. No abstract available.

21.

Characterization of rabbit cytochrome P450IIC4 cDNA and induction by phenobarbital of related hepatic mRNA levels.

Zhao J, Leighton JK, Kemper B.

Biochem Biophys Res Commun. 1987 Jul 15;146(1):224-31.

PMID:
3453118

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