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About FDA

Laboratory of Clinical Pharmacology Publications: 2003-2007

U.S. Mail Only:
Life Sciences Building #64
10903 New Hampshire Ave, 
Room 2072
Silver Spring, MD 20993
Courier Delivery Only:
Life Sciences Bldg. #64
Room 2072, HFD-910
10903 New Hampshire Ave.
Silver Spring, MD  20993

Phone:  (301) 796-0078

Thomas J. Colatsky, Ph.D., Acting Director

Fax:  (301) 796-9814


Journal Articles


Asafu-Adjaye EB, Faustino PJ, Tawakkul MA, Anderson LW, Yu LX, Kwon H, Volpe DA. Validation and application of a stability-indicating HPLC method for the in vitro determination of gastric and intestinal stability of venlafaxine. J Pharm Biomed Anal, 2007, 43(5):1854-9.

Uppoor RS, Mummaneni P, Cooper E, Pien HH, Sorensen AG, Collins J, Mehta MU, and Yasuda SU. The use of imaging in the early development of neuropharmacological drugs:  A survey of approved NDAs.  Clin Pharm & Therap, 2007 advance online publication.


Cherstniakova SA, Garcia GE, Strong J, Bi D, Weitz J, Roy MJ, Cantilena LR.  Rapid determination of N,N-diethyl-m-toluamide and permethrin in human plasma by gas chromatography-mass spectrometry and pyridostigmine bromide by high-performance liquid chromatography.  J Anal Toxicol, 2006 30:21-6

Collins JM. The NCI Developmental Therapeutics. Clin Adv Hematol Oncol, 2006 4:271-73

Sun H, Collins JM, Managner TJ, Muzik O, Shields AP.  Imaging the pharmacokinetics of [F-18]FAU in patients with tumors: PET studies.  Cancer Chemother and Pharmacol, 2006 57:343-8.

Cysyk RL, Parker RJ, Barchi JJ Jr, Steeg PS, Hartman NR, Strong JM.  Reaction of geldanamycin and C17-substituted analogues with glutathione: product identifications and pharmacological implications.  Chem Res Toxicol, 2006 19:376-81.

Klecker RW, Cysyk RL, Collins JM. Zebularine metabolism by aldehyde oxidase in hepatic cytosol from humans, monkeys, dogs, rats, and mice: influence of sex and inhibitors. Bioorg Med Chem, 2006 14:62-6.

Zhang L, Strong JM, Wei Q, Lesko LJ, Huang SM. Scientific perspectives on drug transporters and their role in drug interactions. Mol Pharm, 2006 3:62-9.


Anderson LW, Collins JM, Klecker RW, Katki AG, Parchment RE, Boinpally RR, LoRusso P, and Ivy SP. Metabolic profile of XK469 (2 (R) –[4-(7-chloro-2-quinoxalinyl) oxyphenyoxy]-propionic acid; NSC698215) in patients and in vitro: low potential for active or toxic metabolites or for drug-drug interactions. Cancer Chemother Pharmacol, 2005 56:351-7.

Collins JM. Imaging and other biomarkers in early clinical trials: one step at a time or re-engineering drug development? J Clin Oncol, 2005 23:5417-9.

Nimmagadda S, Mangner TJ, Sun H, Klecker RW Jr, Muzik O, Lawhorn- Crews JM,  Douglas KA, Collins JM, and Shields AF. Biodistribution and radiation dosimetry estimates of 1-(2’-deoxy-2’- (18)F-fluoro-1-beta-D-arabinofuranosyl)-5-bromouracil): PET imaging studies in dogs. J Nucl Med, 2005 46:1916-22.

Parker RJ, Hartman NR, Roecklein BA, Mortko H, Kupferberg HJ, Stables J, Strong JM. Stability and comparative metabolism of selected felbamate metabolites and postulated fluorofelbamate metabolites by postmitochondrial suspensions. Chem Res Toxicol, 2005 18:1842 – 8.

Shields F, Briston DA, Chandaupatla S, Douglas KA, Lawhorn-Crews J, Collins JM, Mangner TJ, Heilbrun LK, Muzik O. A simplified analysis of [18F]3'-deoxy-3'-fluorothymidine metabolism and retention. Eur J Nucl Med and Mol Imaging, 2005 32:1269-75.

Sun H, Mangner TJ, Collins JM, Muzik O, Douglas K, and Shields AF. Imaging DNA synthesis in vivo with 18F-FMAU and PET. J Nucl Med, 2005 46:292-6.

Sun H, Sloan A, Mangner TJ, Vaishampayan U, Muzik O, Collins JM, Douglas K, and Shields AF. Imaging DNA synthesis with [18F]FMAU and positron emission tomography in patients with cancers. Eur J Nucl Med Mol Imaging, 2005 32:15-22.


Cantilena LR, Katki AG, Klecker RW, and Collins JM. Metabolism by N acetyltransferase 1 in vitro and in healthy volunteers: A prototype for targeted inhibition. J Clin Pharmacol, 44:1405-11.

Eiseman JL, Brown-Proctor C, Kinahan PE, Collins JM, Anderson LW, Joseph E, Hamburger DR, Pan SS, Mathis CA, Egorin MJ, and Klecker RW. Distribution of 1-(2-deoxy-2-fluoro-beta-D-arabinofuranosyl) uracil in mice bearing colorectal cancer xenografts: rationale for therapeutic use as a positron emission tomography probe for thymidylate synthase. Clin Cancer Res, 2004 10:6669-76.


Sun H, Collins JM, Mangner TJ, Muzik O, Shields AF. Imaging [F-18]FAU [1-(2'-deoxy-2'-fluoro-beta-D-arabinofuranosyl) uracil] in dogs. Nucl Med and Biol,  2003 30:25-30.

Collins JM. Functional imaging in phase I studies: decorations or decision making? J Clin Oncol, 2003 23:2807-9.

Book Chapters


Strong JM and Huang SM, US Regulatory Perspective: Drug-drug Interactions in Drug-drug Interactions in Drug Development, Ed. Li AP 2007, John Wiley and Son.

Nallani SC, Strong JM and Huang SM.  Use of hepatocytes for characterizing a candidate drug’s metabolism and drug interaction potential in Hepatotoxicity: From Genomics to in vivo Models, Ed. Saura C, 2007 Sahu. Wiley Co.

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