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Items: 28

1.

The West coast regional safety pharmacology society meeting update: Filling translational gaps in safety assessment.

Abi-Gerges N, McMahon C, Vargas H, Sager P, Chui R, Stevens D, Davila J, Schaub JR, Wu JC, Del Rio C, Mathes C, Miller PE, Burns-Naas LA, Ghetti A.

J Pharmacol Toxicol Methods. 2019 Jul - Aug;98:106582. doi: 10.1016/j.vascn.2019.106582. Epub 2019 May 9. Review.

PMID:
31077805
2.

Recommendations from a global cross-company data sharing initiative on the incorporation of recovery phase animals in safety assessment studies to support first-in-human clinical trials.

Sewell F, Chapman K, Baldrick P, Brewster D, Broadmeadow A, Brown P, Burns-Naas LA, Clarke J, Constan A, Couch J, Czupalla O, Danks A, DeGeorge J, de Haan L, Hettinger K, Hill M, Festag M, Jacobs A, Jacobson-Kram D, Kopytek S, Lorenz H, Moesgaard SG, Moore E, Pasanen M, Perry R, Ragan I, Robinson S, Schmitt PM, Short B, Lima BS, Smith D, Sparrow S, van Bekkum Y, Jones D.

Regul Toxicol Pharmacol. 2014 Oct;70(1):413-29. doi: 10.1016/j.yrtph.2014.07.018. Epub 2014 Jul 29.

3.

Cardiovascular differentiation of imatinib and bosutinib in the rat.

Heyen JR, Hu W, Jamieson J, Thibault S, Batugo M, Loi CM, Burns-Naas LA, McHarg AD, Jessen B.

Int J Hematol. 2013 Nov;98(5):597-607. doi: 10.1007/s12185-013-1453-2. Epub 2013 Oct 19.

PMID:
24142766
4.

Intermittent oral coadministration of a gamma secretase inhibitor with dexamethasone mitigates intestinal goblet cell hyperplasia in rats.

Aguirre SA, Liu L, Hosea NA, Scott W, May JR, Burns-Naas LA, Randolph S, Denlinger RH, Han B.

Toxicol Pathol. 2014;42(2):422-34. doi: 10.1177/0192623313486315. Epub 2013 May 7.

PMID:
23651588
5.

Immunotoxicology: fifty years of global scientific progress.

McKarns SC, Kerkvliet NI, Dean JH, Bonn MB, Cohen MD, Franko J, Laiosa MD, Lawrence BP, Luebke RW, Luster MI, Miller PG, Palmer RK, Pfau JC, Raman P, Regal JF, Rodgers KE, Schondelmeyer RS, Zhang X, Burns-Naas LA.

J Immunotoxicol. 2012 Oct-Dec;9(4):339-40. doi: 10.3109/1547691X.2012.658530. Epub 2012 Oct 19.

PMID:
23078377
6.

Epithelial tissue hyperplasia induced by the RAF inhibitor PF-04880594 is attenuated by a clinically well-tolerated dose of the MEK inhibitor PD-0325901.

Torti VR, Wojciechowicz D, Hu W, John-Baptiste A, Evering W, Troche G, Marroquin LD, Smeal T, Yamazaki S, Palmer CL, Burns-Naas LA, Bagrodia S.

Mol Cancer Ther. 2012 Oct;11(10):2274-83. doi: 10.1158/1535-7163.MCT-11-0984. Epub 2012 Jul 2.

7.

Developmental immunotoxicity (DIT) testing of pharmaceuticals: current practices, state of the science, knowledge gaps, and recommendations.

Collinge M, Burns-Naas LA, Chellman GJ, Kawabata TT, Komocsar WJ, Piccotti JR, Shenton J, Wierda D.

J Immunotoxicol. 2012 Apr-Jun;9(2):210-30. doi: 10.3109/1547691X.2012.661486. Epub 2012 Mar 19. Review.

PMID:
22428536
8.

Identification and elucidation of the biology of adverse events: the challenges of safety assessment and translational medicine.

Turteltaub KW, Davis MA, Burns-Naas LA, Lawton MP, Clark AM, Reynolds JA.

Clin Cancer Res. 2011 Nov 1;17(21):6641-5. doi: 10.1158/1078-0432.CCR-11-1106.

9.

Considerations regarding nonhuman primate use in safety assessment of biopharmaceuticals.

Buckley LA, Chapman K, Burns-Naas LA, Todd MD, Martin PL, Lansita JA.

Int J Toxicol. 2011 Oct;30(5):583-90. doi: 10.1177/1091581811415875. Review.

PMID:
22013138
10.

Appropriate use of recovery groups in nonclinical toxicity studies: value in a science-driven case-by-case approach.

Pandher K, Leach MW, Burns-Naas LA.

Vet Pathol. 2012 Mar;49(2):357-61. doi: 10.1177/0300985811415701. Epub 2011 Aug 1.

PMID:
21810619
11.

Impaired reproduction in adult male, but not female, rats following juvenile treatment with the aromatase inhibitor, exemestane.

Cappon GD, Chapin RE, Hurtt ME, Wajnrajch MP, Burns-Naas LA.

Birth Defects Res B Dev Reprod Toxicol. 2011 Aug;92(4):304-13. doi: 10.1002/bdrb.20307. Epub 2011 Jun 15.

PMID:
21678547
12.

Summary of a workshop on nonclinical and clinical immunotoxicity assessment of immunomodulatory drugs.

Piccotti JR, Lebrec HN, Evans E, Herzyk DJ, Hastings KL, Burns-Naas LA, Gourley IS, Wierda D, Kawabata TT.

J Immunotoxicol. 2009 Mar;6(1):1-10. doi: 10.1080/15476910802656440.

PMID:
19519157
13.

Lack of respiratory and contact sensitizing potential of the intranasal antiviral drug candidate rupintrivir (AG7088): a weight-of-the-evidence evaluation.

Burns-Naas LA, Lee C, Evering W, Ahern L, Webber S, Zorbas M.

J Immunotoxicol. 2005 Jul 1;2(3):123-39. doi: 10.1080/15476910500203925.

PMID:
18958666
14.

What's so special about the developing immune system?

Burns-Naas LA, Hastings KL, Ladics GS, Makris SL, Parker GA, Holsapple MP.

Int J Toxicol. 2008 Mar-Apr;27(2):223-54. doi: 10.1080/10915810801978110. Review.

PMID:
18404545
15.

Increase in thyroid follicular cell tumors in nelfinavir-treated rats observed in a 2-year carcinogenicity study is consistent with a rat-specific mechanism of thyroid neoplasia.

Burns-Naas LA, Zorbas M, Jessen B, Evering W, Stevens G, Ivett JL, Ryan TE, Cook JC, Capen CC, Chen M, Furman G, Theiss JC, Webber S, Wu E, Shetty B, Gasser R, McClain RM.

Hum Exp Toxicol. 2005 Dec;24(12):643-54.

PMID:
16408618
16.

"Omics" Technologies and the Immune System (a) , (b).

Burns-Naas LA, Dearman RJ, Germolec DR, Kaminski NE, Kimber I, Ladics GS, Luebke RW, Pfau JC, Pruett SB.

Toxicol Mech Methods. 2006;16(2-3):101-19. doi: 10.1080/15376520600558424.

PMID:
20021002
17.

Developmental toxicology evaluations--issues with including neurotoxicology and immunotoxicology assessments in reproductive toxicology studies.

Ladics GS, Chapin RE, Hastings KL, Holsapple MP, Makris SL, Sheets LP, Woolhiser MR, Burns-Naas LA.

Toxicol Sci. 2005 Nov;88(1):24-9. Epub 2005 Aug 24.

PMID:
16120748
18.

In vitro antiviral activity and single-dose pharmacokinetics in humans of a novel, orally bioavailable inhibitor of human rhinovirus 3C protease.

Patick AK, Brothers MA, Maldonado F, Binford S, Maldonado O, Fuhrman S, Petersen A, Smith GJ 3rd, Zalman LS, Burns-Naas LA, Tran JQ.

Antimicrob Agents Chemother. 2005 Jun;49(6):2267-75.

19.

Immunotoxicity evaluation of nelfinavir in rats.

Burns-Naas LA, White KL Jr, McCay JA, Ivett J, Webber S, Zorbas M.

Hum Exp Toxicol. 2005 Feb;24(2):67-78.

PMID:
15850281
20.

A proposed testing framework for developmental immunotoxicology (DIT).

Holsapple MP, Burns-Naas LA, Hastings KL, Ladics GS, Lavin AL, Makris SL, Yang Y, Luster MI.

Toxicol Sci. 2005 Jan;83(1):18-24. Epub 2004 Sep 29.

PMID:
15456913
21.

Symposium summary: children's health risk--what's so special about the developing immune system?

Holsapple MP, Paustenbach DJ, Charnley G, West LJ, Luster MI, Dietert RR, Burns-Naas LA.

Toxicol Appl Pharmacol. 2004 Aug 15;199(1):61-70. Review.

PMID:
15289091
22.

Absence of reproductive and developmental toxicity in rats following oral dosing with nelfinavir.

Burns-Naas LA, Stump DG, Webber S, Holson JF, Masarjian L, Furman G, Zorbas M.

Regul Toxicol Pharmacol. 2003 Dec;38(3):304-16.

PMID:
14623481
23.

Absence of embryo-fetal toxicity in rats or rabbits following oral dosing with nelfinavir.

Burns-Naas LA, Webber S, Stump DG, Holson JF, Masarjian L, Zorbas M.

Regul Toxicol Pharmacol. 2003 Dec;38(3):291-303.

PMID:
14623480
24.

Inhalation toxicology of octamethylcyclotetrasiloxane (D4) following a 3-month nose-only exposure in Fischer 344 rats.

Burns-Naas LA, Meeks RG, Kolesar GB, Mast RW, Elwell MR, Hardisty JF, Thevenaz P.

Int J Toxicol. 2002 Jan-Feb;21(1):39-53.

PMID:
11936898
25.

Toxicology and humoral immunity assessment of octamethylcyclotetrasiloxane (D4) following a 28-day whole body vapor inhalation exposure in Fischer 344 rats.

Klykken PC, Galbraith TW, Kolesar GB, Jean PA, Woolhiser MR, Elwell MR, Burns-Naas LA, Mast RW, McCay JA, White KL Jr, Munson AE.

Drug Chem Toxicol. 1999 Nov;22(4):655-77.

PMID:
10536755
26.

Induction of hepatic xenobiotic metabolizing enzymes in female Fischer-344 rats following repeated inhalation exposure to decamethylcyclopentasiloxane (D5).

McKim JM Jr, Choudhuri S, Wilga PC, Madan A, Burns-Naas LA, Gallavan RH, Mast RW, Naas DJ, Parkinson A, Meeks RG.

Toxicol Sci. 1999 Jul;50(1):10-9.

PMID:
10445748
27.

Inhalation toxicology of decamethylcyclopentasiloxane (D5) following a 3-month nose-only exposure in Fischer 344 rats.

Burns-Naas LA, Mast RW, Meeks RG, Mann PC, Thevenaz P.

Toxicol Sci. 1998 Jun;43(2):230-40.

PMID:
9710964
28.

Toxicology and humoral immunity assessment of decamethylcyclopentasiloxane (D5) following a 1-month whole body inhalation exposure in Fischer 344 rats.

Burns-Naas LA, Mast RW, Klykken PC, McCay JA, White KL Jr, Mann PC, Naas DJ.

Toxicol Sci. 1998 May;43(1):28-38.

PMID:
9629617

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