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Items: 50

1.

Exposure assessments in reproductive and developmental toxicity testing: An IQ-DruSafe industry survey on current practices and experiences in support of exposure-based high dose selection.

Andrews PA, McNerney ME, DeGeorge JJ.

Regul Toxicol Pharmacol. 2019 Oct;107:104413. doi: 10.1016/j.yrtph.2019.104413. Epub 2019 Jun 20.

PMID:
31229519
2.

Analysis of exposure margins in developmental toxicity studies for detection of human teratogens.

Andrews PA, Blanset D, Costa PL, Green M, Green ML, Jacobs A, Kadaba R, Lebron JA, Mattson B, McNerney ME, Minck D, Oliveira LC, Theunissen PT, DeGeorge JJ.

Regul Toxicol Pharmacol. 2019 Jul;105:62-68. doi: 10.1016/j.yrtph.2019.04.005. Epub 2019 Apr 11.

PMID:
30981719
3.

Current nonclinical testing paradigms in support of safe clinical trials: An IQ Consortium DruSafe perspective.

Butler LD, Guzzie-Peck P, Hartke J, Bogdanffy MS, Will Y, Diaz D, Mortimer-Cassen E, Derzi M, Greene N, DeGeorge JJ.

Regul Toxicol Pharmacol. 2017 Jul 31;87 Suppl 3:S1-S15. doi: 10.1016/j.yrtph.2017.05.009. Epub 2017 May 5.

PMID:
28483710
4.

Evaluation of Therapeutics for Advanced-Stage Heart Failure and Other Severely-Debilitating or Life-Threatening Diseases.

Prescott JS, Andrews PA, Baker RW, Bogdanffy MS, Fields FO, Keller DA, Lapadula DM, Mahoney NM, Paul DE, Platz SJ, Reese DM, Stoch SA, DeGeorge JJ.

Clin Pharmacol Ther. 2017 Aug;102(2):219-227. doi: 10.1002/cpt.730. Epub 2017 Jun 21. Review.

PMID:
28474798
5.

Scientific Knowledge and Technology, Animal Experimentation, and Pharmaceutical Development.

Kinter LB, DeGeorge JJ.

ILAR J. 2016 Dec;57(2):101-108. doi: 10.1093/ilar/ilw027.

PMID:
28053064
6.

Role of chronic toxicology studies in revealing new toxicities.

Galijatovic-Idrizbegovic A, Miller JE, Cornell WD, Butler JA, Wollenberg GK, Sistare FD, DeGeorge JJ.

Regul Toxicol Pharmacol. 2016 Dec;82:94-98. doi: 10.1016/j.yrtph.2016.10.010. Epub 2016 Oct 18.

PMID:
27769827
7.

Assessment of the clinical cardiac drug-drug interaction associated with the combination of hepatitis C virus nucleotide inhibitors and amiodarone in guinea pigs and rhesus monkeys.

Regan CP, Morissette P, Regan HK, Travis JJ, Gerenser P, Wen J, Fitzgerald K, Gruver S, DeGeorge JJ, Sannajust FJ.

Hepatology. 2016 Nov;64(5):1430-1441. doi: 10.1002/hep.28752. Epub 2016 Aug 23.

PMID:
27474787
8.

Characterization of an investigative safety pharmacology model to assess comprehensive cardiac function and structure in chronically instrumented conscious beagle dogs.

Regan CP, Stump GL, Detwiler TJ, Chen L, Regan HK, Gilberto DB, DeGeorge JJ, Sannajust FJ.

J Pharmacol Toxicol Methods. 2016 Sep-Oct;81:107-14. doi: 10.1016/j.vascn.2016.05.002. Epub 2016 May 7.

PMID:
27166580
9.

An Evaluation of the Impact of PD-1 Pathway Blockade on Reproductive Safety of Therapeutic PD-1 Inhibitors.

Poulet FM, Wolf JJ, Herzyk DJ, DeGeorge JJ.

Birth Defects Res B Dev Reprod Toxicol. 2016 Apr;107(2):108-19. doi: 10.1002/bdrb.21176. Epub 2016 Apr 7. Review.

PMID:
27062127
10.

Toxicogenomics in drug development: a match made in heaven?

Qin C, Tanis KQ, Podtelezhnikov AA, Glaab WE, Sistare FD, DeGeorge JJ.

Expert Opin Drug Metab Toxicol. 2016 Aug;12(8):847-9. doi: 10.1080/17425255.2016.1175437. Epub 2016 Apr 21. No abstract available.

PMID:
27050123
11.

Regulatory Forum Commentary* Counterpoint: Dose Selection for Tg.rasH2 Mouse Carcinogenicity Studies.

Darbes J, Sistare FD, DeGeorge JJ.

Toxicol Pathol. 2015 Jul;43(5):621-7. doi: 10.1177/0192623315587722. Epub 2015 Jun 4.

PMID:
26047967
12.

Promise of new translational safety biomarkers in drug development and challenges to regulatory qualification.

Sistare FD, DeGeorge JJ.

Biomark Med. 2011 Aug;5(4):497-514. doi: 10.2217/bmm.11.52. Review.

PMID:
21861671
13.

An analysis of pharmaceutical experience with decades of rat carcinogenicity testing: support for a proposal to modify current regulatory guidelines.

Sistare FD, Morton D, Alden C, Christensen J, Keller D, Jonghe SD, Storer RD, Reddy MV, Kraynak A, Trela B, Bienvenu JG, Bjurström S, Bosmans V, Brewster D, Colman K, Dominick M, Evans J, Hailey JR, Kinter L, Liu M, Mahrt C, Marien D, Myer J, Perry R, Potenta D, Roth A, Sherratt P, Singer T, Slim R, Soper K, Fransson-Steen R, Stoltz J, Turner O, Turnquist S, van Heerden M, Woicke J, DeGeorge JJ.

Toxicol Pathol. 2011 Jun;39(4):716-44. doi: 10.1177/0192623311406935.

PMID:
21666103
14.

Changes to ICH guideline M3: new and revised guidance on nonclinical safety studies to support human clinical trials and marketing authorization.

Ledwith BJ, DeGeorge JJ.

Clin Pharmacol Ther. 2011 Feb;89(2):295-9. doi: 10.1038/clpt.2010.273. Epub 2010 Dec 22. No abstract available.

PMID:
21178992
15.

An evaluation of chronic 6- and 12-month rat toxicology studies as predictors of 2-year tumor outcome.

Reddy MV, Sistare FD, Christensen JS, Deluca JG, Wollenberg GK, Degeorge JJ.

Vet Pathol. 2010 Jul;47(4):614-29. doi: 10.1177/0300985810373242. Epub 2010 Jun 1.

PMID:
20516294
16.

An industry perspective on the utility of short-term carcinogenicity testing in transgenic mice in pharmaceutical development.

Storer RD, Sistare FD, Reddy MV, DeGeorge JJ.

Toxicol Pathol. 2010 Jan;38(1):51-61. doi: 10.1177/0192623309351718. Epub 2009 Nov 5. Review.

PMID:
19893055
17.

Safety assessment of drug metabolites: implications of regulatory guidance and potential application of genetically engineered mouse models that express human P450s.

Powley MW, Frederick CB, Sistare FD, DeGeorge JJ.

Chem Res Toxicol. 2009 Feb;22(2):257-62. doi: 10.1021/tx8004373.

PMID:
19170595
18.

Applications of toxicogenomics to nonclinical drug development: regulatory science considerations.

Sistare FD, Degeorge JJ.

Methods Mol Biol. 2008;460:239-61. doi: 10.1007/978-1-60327-048-9_12.

PMID:
18449491
19.

Preclinical predictors of clinical safety: opportunities for improvement.

Sistare FD, DeGeorge JJ.

Clin Pharmacol Ther. 2007 Aug;82(2):210-4. Epub 2007 May 16. Review.

PMID:
17507920
20.

The duration of non-rodent toxicity studies for pharmaceuticals. International Conference on Harmonication (ICH).

DeGeorge JJ, Meyers LL, Takahashi M, Contrera JF.

Toxicol Sci. 1999 Jun;49(2):143-55. Review.

PMID:
10416259
21.

Predictive value of preclinical toxicology studies for platinum anticancer drugs.

Clark DL, Andrews PA, Smith DD, DeGeorge JJ, Justice RL, Beitz JG.

Clin Cancer Res. 1999 May;5(5):1161-7.

22.

In vivo transgenic bioassays and assessment of the carcinogenic potential of pharmaceuticals.

Contrera JF, DeGeorge JJ.

Environ Health Perspect. 1998 Feb;106 Suppl 1:71-80. Review.

23.

Regulatory considerations for preclinical development of anticancer drugs.

DeGeorge JJ, Ahn CH, Andrews PA, Brower ME, Giorgio DW, Goheer MA, Lee-Ham DY, McGuinn WD, Schmidt W, Sun CJ, Tripathi SC.

Cancer Chemother Pharmacol. 1998;41(3):173-85. Review.

PMID:
9443633
24.

Considerations for toxicology studies of respiratory drug products.

DeGeorge JJ, Ahn CH, Andrews PA, Brower ME, Choi YS, Chun MY, Du T, Lee-Ham DY, McGuinn WD, Pei L, Sancilio LF, Schmidt W, Sheevers HV, Sun CJ, Tripathi S, Vogel WM, Whitehurst V, Williams S, Taylor AS.

Regul Toxicol Pharmacol. 1997 Apr;25(2):189-93. Review.

PMID:
9185894
25.

Carcinogenicity testing and the evaluation of regulatory requirements for pharmaceuticals.

Contrera JF, Jacobs AC, DeGeorge JJ.

Regul Toxicol Pharmacol. 1997 Apr;25(2):130-45.

PMID:
9185889
26.

Response to Monro and Mehta proposal for use of single-dose toxicology studies to support single-dose studies of new drugs in humans.

Choudary J, Contrera JF, DeFelice A, DeGeorge JJ, Farrelly JG, Fitzgerald G, Goheer MA, Jacobs A, Jordan A, Meyers L, Osterberg R, Resnick C, Sun CJ, Temple RJ.

Clin Pharmacol Ther. 1996 Mar;59(3):265-7. No abstract available.

PMID:
8653988
27.

Food and Drug Administration viewpoints on toxicokinetics: the view from review.

DeGeorge JJ.

Toxicol Pathol. 1995 Mar-Apr;23(2):220-5.

PMID:
7569678
28.

Approaches to the development and marketing approval of drugs that prevent cancer.

Kelloff GJ, Johnson JR, Crowell JA, Boone CW, DeGeorge JJ, Steele VE, Mehta MU, Temeck JW, Schmidt WJ, Burke G, et al.

Cancer Epidemiol Biomarkers Prev. 1995 Jan-Feb;4(1):1-10. Review.

29.

Differences in rates of incorporation of intravenously injected radiolabeled fatty acids into phospholipids of intracerebrally implanted tumor and brain in awake rats.

Nariai T, DeGeorge JJ, Greig NH, Genka S, Rapoport SI, Purdon AD.

Clin Exp Metastasis. 1994 May;12(3):213-25.

PMID:
8194196
30.

Effects of pentobarbital on incorporation of plasma palmitate into rat brain.

Yamazaki S, DeGeorge JJ, Bell JM, Rapoport SI.

Anesthesiology. 1994 Jan;80(1):151-8.

PMID:
8291704
31.

Regulatory considerations for oligonucleotide drugs: updated recommendations for pharmacology and toxicology studies.

Black LE, Farrelly JG, Cavagnaro JA, Ahn CH, DeGeorge JJ, Taylor AS, DeFelice AF, Jordan A.

Antisense Res Dev. 1994 Winter;4(4):299-301.

PMID:
7734946
32.

Guidance for development of chemopreventive agents.

Kelloff GJ, Johnson JR, Crowell JA, Boone CW, DeGeorge JJ, Steele VE, Mehta MU, Temeck JW, Schmidt WJ, Burke G, et al.

J Cell Biochem Suppl. 1994;20:25-31. No abstract available.

PMID:
7616748
33.
34.

Regulatory considerations for evaluating the pharmacology and toxicology of antisense drugs.

Black LE, Degeorge JJ, Cavagnaro JA, Jordan A, Ahn CH.

Antisense Res Dev. 1993 Winter;3(4):399-404.

PMID:
8155981
35.

A quantitative method for measuring regional in vivo fatty-acid incorporation into and turnover within brain phospholipids: review and critical analysis.

Robinson PJ, Noronha J, DeGeorge JJ, Freed LM, Nariai T, Rapoport SI.

Brain Res Brain Res Rev. 1992 Sep-Dec;17(3):187-214. Review.

PMID:
1467810
37.

In vivo incorporation of [9,10(-3)H]-palmitate into a rat metastatic brain-tumor model.

Nariai T, DeGeorge JJ, Greig NH, Rapoport SI.

J Neurosurg. 1991 Apr;74(4):643-9.

PMID:
2002379
38.

Arecoline-stimulated brain incorporation of intravenously administered fatty acids in unanesthetized rats.

DeGeorge JJ, Nariai T, Yamazaki S, Williams WM, Rapoport SI.

J Neurochem. 1991 Jan;56(1):352-5.

PMID:
1824784
39.

Synthesis of a fluorinated fatty acid, dl-erythro-9,10-[18F]difluoropalmitic acid, and biodistribution studies in rats.

Schmall B, Finn RD, Rapoport SI, Noronha JG, DeGeorge JJ, Kiesewetter DO, Simpson NR, Larson SM.

Int J Rad Appl Instrum B. 1990;17(8):805-9.

PMID:
2079427
40.

Quantitative analysis of polyols in human plasma and cerebrospinal fluid.

Kusmierz J, DeGeorge JJ, Sweeney D, May C, Rapoport SI.

J Chromatogr. 1989 Dec 29;497:39-48.

PMID:
2625478
41.

Intravenous injection of [1-14C]arachidonate to examine regional brain lipid metabolism in unanesthetized rats.

DeGeorge JJ, Noronha JG, Bell J, Robinson P, Rapoport SI.

J Neurosci Res. 1989 Nov;24(3):413-23.

PMID:
2512392
42.

Nerve growth factor rapidly stimulates arachidonate metabolism in PC12 cells: potential involvement in nerve fiber growth.

DeGeorge JJ, Walenga R, Carbonetto S.

J Neurosci Res. 1988 Oct-Dec;21(2-4):323-32.

PMID:
3145981
43.

Differential effects of phorbol ester and diacylglycerols on inositol phosphate formation in C62B glioma cells.

Brooks RC, Morell P, DeGeorge JJ, McCarthy KD, Lapetina EG.

Biochem Biophys Res Commun. 1987 Oct 29;148(2):701-8.

PMID:
3479984
44.
45.
46.
48.

Adrenergic and cholinergic stimulation of arachidonate and phosphatidate metabolism in cultured astroglial cells.

DeGeorge JJ, Morell P, McCarthy KD, Lapetina EG.

Neurochem Res. 1986 Jul;11(7):1061-71.

PMID:
2875401
49.

Cholinergic stimulation of arachidonic acid and phosphatidic acid metabolism in C62B glioma cells.

DeGeorge JJ, Morell P, McCarthy KD, Lapetina EG.

J Biol Chem. 1986 Mar 5;261(7):3428-33.

50.

Concanavalin A stimulates neuron-substratum adhesion and nerve fiber outgrowth in culture.

DeGeorge JJ, Slepecky N, Carbonetto S.

Dev Biol. 1985 Oct;111(2):335-51.

PMID:
2995164

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