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Items: 26

1.

First FDA approval of dual anti-HER2 regimen: pertuzumab in combination with trastuzumab and docetaxel for HER2-positive metastatic breast cancer.

Blumenthal GM, Scher NS, Cortazar P, Chattopadhyay S, Tang S, Song P, Liu Q, Ringgold K, Pilaro AM, Tilley A, King KE, Graham L, Rellahan BL, Weinberg WC, Chi B, Thomas C, Hughes P, Ibrahim A, Justice R, Pazdur R.

Clin Cancer Res. 2013 Sep 15;19(18):4911-6. doi: 10.1158/1078-0432.CCR-13-1212. Epub 2013 Jun 25.

2.

Eribulin mesylate for the treatment of patients with refractory metastatic breast cancer: use of a "physician's choice" control arm in a randomized approval trial.

Donoghue M, Lemery SJ, Yuan W, He K, Sridhara R, Shord S, Zhao H, Marathe A, Kotch L, Jee J, Wang Y, Zhou L, Adams WM, Jarral V, Pilaro A, Lostritto R, Gootenberg JE, Keegan P, Pazdur R.

Clin Cancer Res. 2012 Mar 15;18(6):1496-505. doi: 10.1158/1078-0432.CCR-11-2149. Epub 2012 Jan 26.

3.

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
4.

U.S. Food and Drug Administration approval: ofatumumab for the treatment of patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab.

Lemery SJ, Zhang J, Rothmann MD, Yang J, Earp J, Zhao H, McDougal A, Pilaro A, Chiang R, Gootenberg JE, Keegan P, Pazdur R.

Clin Cancer Res. 2010 Sep 1;16(17):4331-8. doi: 10.1158/1078-0432.CCR-10-0570. Epub 2010 Jul 2.

5.

U.S. Food and Drug Administration approval: panitumumab for epidermal growth factor receptor-expressing metastatic colorectal carcinoma with progression following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

Giusti RM, Shastri K, Pilaro AM, Fuchs C, Cordoba-Rodriguez R, Koti K, Rothmann M, Men AY, Zhao H, Hughes M, Keegan P, Weiss KD, Pazdur R.

Clin Cancer Res. 2008 Mar 1;14(5):1296-302. doi: 10.1158/1078-0432.CCR-07-1354.

6.

Nonclinical toxicology in support of licensure of gene therapies. Arlington, VA, USA, March 13-14, 2003.

Frederickson RM, Carter BJ, Pilaro AM.

Mol Ther. 2003 Jul;8(1):8-10. No abstract available.

7.

Clinical infection control in gene therapy: a multidisciplinary conference.

Evans ME, Jordan CT, Chang SM, Conrad C, Gerberding JL, Kaufman HL, Mayhall CG, Nolta JA, Pilaro AM, Sullivan S, Weber DJ, Wivel NA.

Infect Control Hosp Epidemiol. 2000 Oct;21(10):659-73. Review.

PMID:
11083185
8.

FDA comments on phase I clinical trials without vector biodistribution data.

Epstein S, Bauer S, Miller A, Pilaro A, Noguchi P.

Nat Genet. 1999 Aug;22(4):326. No abstract available.

PMID:
10431234
9.

Safety assessment of biotechnology-derived pharmaceuticals: ICH and beyond.

Serabian MA, Pilaro AM.

Toxicol Pathol. 1999 Jan-Feb;27(1):27-31. Review.

PMID:
10367669
10.

Preclinical development strategies for novel gene therapeutic products.

Pilaro AM, Serabian MA.

Toxicol Pathol. 1999 Jan-Feb;27(1):4-7. Review.

PMID:
10367665
11.
12.

TNF-alpha is a principal cytokine involved in the recruitment of NK cells to liver parenchyma.

Pilaro AM, Taub DD, McCormick KL, Williams HM, Sayers TJ, Fogler WE, Wiltrout RH.

J Immunol. 1994 Jul 1;153(1):333-42.

PMID:
8207246
13.

Quantitative analysis of rod-cored vesicles and dense granules of large granular lymphocytes in the liver, spleen, and peripheral blood of rats.

Kaneda K, Pilaro AM, Sayers TJ, Nagashima K, Gonda MA, Ortaldo JR, Wiltrout RH.

Cell Tissue Res. 1994 Apr;276(1):187-95.

PMID:
8187160
14.

A method for obtaining and culturing large numbers of purified organ-derived murine endothelial cells.

MacPhee MJ, Wiltrout RH, McCormick KL, Sayers TJ, Pilaro AM.

J Leukoc Biol. 1994 Apr;55(4):467-75.

PMID:
8145017
15.

Purification and cloning of a novel serine protease, RNK-Tryp-2, from the granules of a rat NK cell leukemia.

Sayers TJ, Wiltrout TA, Smyth MJ, Ottaway KS, Pilaro AM, Sowder R, Henderson LE, Sprenger H, Lloyd AR.

J Immunol. 1994 Mar 1;152(5):2289-97.

PMID:
8133042
16.

Substrate-specific proteases (BLT-esterase) are localized predominantly in the natural killer cells of unprimed mice.

Sayers TJ, Mason LH, Pilaro A, Wiltrout TA, Komschlies K, Munger WL, Wiltrout RH.

J Leukoc Biol. 1993 Apr;53(4):454-61.

PMID:
8482926
17.

c-Ets-1 protein is hyperphosphorylated during mitosis.

Fleischman LF, Pilaro AM, Murakami K, Kondoh A, Fisher RJ, Papas TS.

Oncogene. 1993 Mar;8(3):771-80.

PMID:
8437861
18.

In vivo distribution and cytokine gene expression by enriched mouse LAK effector cells.

Futami H, Pilaro AM, Gruys ME, Back TC, Young HA, Wiltrout RH.

Biotherapy. 1991;3(3):219-32.

PMID:
1906724
19.

An improved in vitro assay to quantitate chemotaxis of rat peripheral blood large granular lymphocytes (LGL).

Pilaro AM, Sayers TJ, McCormick KL, Reynolds CW, Wiltrout RH.

J Immunol Methods. 1990 Dec 31;135(1-2):213-23.

PMID:
2177075
20.
21.
22.

Activation of liver macrophages following phenobarbital treatment of rats.

Laskin DL, Robertson FM, Pilaro AM, Laskin JD.

Hepatology. 1988 Sep-Oct;8(5):1051-5.

PMID:
2971014
23.

Functional and biochemical properties of rat Kupffer cells and peritoneal macrophages.

Laskin DL, Sirak AA, Pilaro AM, Laskin JD.

J Leukoc Biol. 1988 Aug;44(2):71-8.

PMID:
2841398
24.
26.

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