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Items: 27

1.

FDA Approval: Uridine Triacetate for the Treatment of Patients Following Fluorouracil or Capecitabine Overdose or Exhibiting Early-Onset Severe Toxicities Following Administration of These Drugs.

Ison G, Beaver JA, McGuinn WD Jr, Palmby TR, Dinin J, Charlab R, Marathe A, Jin R, Liu Q, Chen XH, Ysern X, Stephens O, Bai G, Wang Y, Dorff SE, Cheng J, Tang S, Sridhara R, Pierce W, McKee AE, Ibrahim A, Kim G, Pazdur R.

Clin Cancer Res. 2016 Sep 15;22(18):4545-9. doi: 10.1158/1078-0432.CCR-16-0638. Epub 2016 Jul 11. Review.

2.

FDA approval summary: vemurafenib for treatment of unresectable or metastatic melanoma with the BRAFV600E mutation.

Kim G, McKee AE, Ning YM, Hazarika M, Theoret M, Johnson JR, Xu QC, Tang S, Sridhara R, Jiang X, He K, Roscoe D, McGuinn WD, Helms WS, Russell AM, Miksinski SP, Zirkelbach JF, Earp J, Liu Q, Ibrahim A, Justice R, Pazdur R.

Clin Cancer Res. 2014 Oct 1;20(19):4994-5000. doi: 10.1158/1078-0432.CCR-14-0776. Epub 2014 Aug 5. Review.

3.

FDA approval: ado-trastuzumab emtansine for the treatment of patients with HER2-positive metastatic breast cancer.

Amiri-Kordestani L, Blumenthal GM, Xu QC, Zhang L, Tang SW, Ha L, Weinberg WC, Chi B, Candau-Chacon R, Hughes P, Russell AM, Miksinski SP, Chen XH, McGuinn WD, Palmby T, Schrieber SJ, Liu Q, Wang J, Song P, Mehrotra N, Skarupa L, Clouse K, Al-Hakim A, Sridhara R, Ibrahim A, Justice R, Pazdur R, Cortazar P.

Clin Cancer Res. 2014 Sep 1;20(17):4436-41. doi: 10.1158/1078-0432.CCR-14-0012. Epub 2014 May 30.

4.

Effects of perfluorooctane sulfonate (PFOS) exposure on markers of inflammation in female B6C3F1 mice.

Mollenhauer MA, Bradshaw SG, Fair PA, McGuinn WD, Peden-Adams MM.

J Environ Sci Health A Tox Hazard Subst Environ Eng. 2011;46(2):97-108. doi: 10.1080/10934529.2011.532418.

PMID:
21170772
5.

ICH guidelines: inception, revision, and implications for drug development.

Wang T, Jacobson-Kram D, Pilaro AM, Lapadula D, Jacobs A, Brown P, Lipscomb J, McGuinn WD.

Toxicol Sci. 2010 Dec;118(2):356-67. doi: 10.1093/toxsci/kfq286. Epub 2010 Sep 22. No abstract available.

PMID:
20861066
6.

Folotyn (pralatrexate injection) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma: U.S. Food and Drug Administration drug approval summary.

Malik SM, Liu K, Qiang X, Sridhara R, Tang S, McGuinn WD Jr, Verbois SL, Marathe A, Williams GM, Bullock J, Tornoe C, Lin SC, Ocheltree T, Vialpando M, Kacuba A, Justice R, Pazdur R.

Clin Cancer Res. 2010 Oct 15;16(20):4921-7. doi: 10.1158/1078-0432.CCR-10-1214. Epub 2010 Aug 25. Review.

7.

Regulatory aspects of oncology drug safety evaluation: past practice, current issues, and the challenge of new drugs.

Rosenfeldt H, Kropp T, Benson K, Ricci MS, McGuinn WD, Verbois SL.

Toxicol Appl Pharmacol. 2010 Mar 1;243(2):125-33. doi: 10.1016/j.taap.2009.12.020. Epub 2010 Jan 4. Review.

PMID:
20045015
8.

N,N,-diethyl-m-toluamide (DEET) suppresses humoral immunological function in B6C3F1 mice.

Keil DE, McGuinn WD, Dudley AC, EuDaly JG, Gilkeson GS, Peden-Adams MM.

Toxicol Sci. 2009 Mar;108(1):110-23. doi: 10.1093/toxsci/kfp001. Epub 2009 Jan 13.

PMID:
19141786
9.

Developmental toxicity in white leghorn chickens following in ovo exposure to perfluorooctane sulfonate (PFOS).

Peden-Adams MM, Stuckey JE, Gaworecki KM, Berger-Ritchie J, Bryant K, Jodice PG, Scott TR, Ferrario JB, Guan B, Vigo C, Boone JS, McGuinn WD, DeWitt JC, Keil DE.

Reprod Toxicol. 2009 Jun;27(3-4):307-18. doi: 10.1016/j.reprotox.2008.10.009. Epub 2008 Nov 21.

PMID:
19071210
10.

Dexrazoxane (Totect): FDA review and approval for the treatment of accidental extravasation following intravenous anthracycline chemotherapy.

Kane RC, McGuinn WD Jr, Dagher R, Justice R, Pazdur R.

Oncologist. 2008 Apr;13(4):445-50. doi: 10.1634/theoncologist.2007-0247.

11.

Approval summary: nelarabine for the treatment of T-cell lymphoblastic leukemia/lymphoma.

Cohen MH, Johnson JR, Massie T, Sridhara R, McGuinn WD Jr, Abraham S, Booth BP, Goheer MA, Morse D, Chen XH, Chidambaram N, Kenna L, Gobburu JV, Justice R, Pazdur R.

Clin Cancer Res. 2006 Sep 15;12(18):5329-35.

12.

The effects of pregnancy on ethanol clearance.

Badger TM, Hidestrand M, Shankar K, McGuinn WD, Ronis MJ.

Life Sci. 2005 Sep 9;77(17):2111-26.

PMID:
15925387
13.

Approval summary for bortezomib for injection in the treatment of multiple myeloma.

Bross PF, Kane R, Farrell AT, Abraham S, Benson K, Brower ME, Bradley S, Gobburu JV, Goheer A, Lee SL, Leighton J, Liang CY, Lostritto RT, McGuinn WD, Morse DE, Rahman A, Rosario LA, Verbois SL, Williams G, Wang YC, Pazdur R.

Clin Cancer Res. 2004 Jun 15;10(12 Pt 1):3954-64. No abstract available.

14.

United States Food and Drug Administration Drug Approval summary: Gefitinib (ZD1839; Iressa) tablets.

Cohen MH, Williams GA, Sridhara R, Chen G, McGuinn WD Jr, Morse D, Abraham S, Rahman A, Liang C, Lostritto R, Baird A, Pazdur R.

Clin Cancer Res. 2004 Feb 15;10(4):1212-8.

15.

Comparing therapeutic and prophylactic protection against the lethal effect of paraoxon.

Petrikovics I, Papahadjopoulos D, Hong K, Cheng TC, Baskin SI, Jiang J, Jaszberenyi JC, Logue BA, Szilasi M, McGuinn WD, Way JL.

Toxicol Sci. 2004 Feb;77(2):258-62. Epub 2003 Jul 11.

PMID:
12857941
16.

The FDA and The Lancet: an exchange.

Hirschfeld S, Kieffer L, McGuinn WD, Rothmann M, Timmer WC.

Lancet. 2001 Aug 4;358(9279):415-6; author reply 417-8. No abstract available.

PMID:
11503618
17.

Long circulating liposomes encapsulating organophosphorus acid anhydrolase in diisopropylfluorophosphate antagonism.

Petrikovics I, Cheng TC, Papahadjopoulos D, Hong K, Yin R, DeFrank JJ, Jaing J, Song ZH, McGuinn WD, Sylvester D, Pei L, Madec J, Tamulinas C, Jaszberenyi JC, Barcza T, Way JL.

Toxicol Sci. 2000 Sep;57(1):16-21.

PMID:
10966507
18.

In vitro studies on sterically stabilized liposomes (SL) as enzyme carriers in organophosphorus (OP) antagonism.

Petrikovics I, McGuinn WD, Sylvester D, Yuzapavik P, Jiang J, Way JL, Papahadjopoulos D, Hong K, Yin R, Cheng TC, DeFrank JJ.

Drug Deliv. 2000 Apr-Jun;7(2):83-9.

PMID:
10892408
19.

Antagonism of paraoxon intoxication by recombinant phosphotriesterase encapsulated within sterically stabilized liposomes.

Petrikovics I, Hong K, Omburo G, Hu QZ, Pei L, McGuinn WD, Sylvester D, Tamulinas C, Papahadjopoulos D, Jaszberenyi JC, Way JL.

Toxicol Appl Pharmacol. 1999 Apr 1;156(1):56-63.

PMID:
10101099
20.

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
21.

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
22.

Cyanide antagonism with carrier erythrocytes and organic thiosulfonates.

Petrikovics I, Cannon EP, McGuinn WD, Pei L, Pu L, Lindner LE, Way JL.

Fundam Appl Toxicol. 1995 Jan;24(1):86-93.

PMID:
7713346
23.

Spectrophotometric determination of paraoxonase within mouse carrier red blood cells.

Pei L, McGuinn WD, Omburo G, Zitzer AH, Petrikovics I, Way JL.

Biotechnol Appl Biochem. 1994 Aug;20 ( Pt 1):35-41.

PMID:
7917064
24.

Antagonism of the lethal effects of cyanide by a synthetic water-soluble cobalt(III) porphyrin compound.

McGuinn WD, Baxter L, Pei L, Petrikovics I, Cannon EP, Way JL.

Fundam Appl Toxicol. 1994 Jul;23(1):76-80.

PMID:
7958566
25.

Encapsulation of rhodanese and organic thiosulfonates by mouse erythrocytes.

Petrikovics I, Pei L, McGuinn WD, Cannon EP, Way JL.

Fundam Appl Toxicol. 1994 Jul;23(1):70-5.

PMID:
7958565
26.

Encapsulation of phosphotriesterase within murine erythrocytes.

Pei L, Omburo G, McGuinn WD, Petrikovics I, Dave K, Raushel FM, Wild JR, DeLoach JR, Way JL.

Toxicol Appl Pharmacol. 1994 Feb;124(2):296-301.

PMID:
8122276
27.

The encapsulation of squid diisopropylphosphorofluoridate-hydrolyzing enzyme within mouse erythrocytes.

McGuinn WD, Cannon EP, Chui CT, Pei L, Petrikovics I, Way JL.

Fundam Appl Toxicol. 1993 Jul;21(1):38-43.

PMID:
8365583

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