• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

Division of Applied Pharmacology Research Recent Publications

Federal Research Center
Life Sciences Building 64, HFD-910
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone: (301) 796-0078 Fax: (301) 796-9818

Thomas J. Colatsky, Ph. D., Director



 Guidance Documents and Reports

Guidance for Industry S8 Immunotoxicity Studies for Human Pharmaceuticals (2006) http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0022-gdl0002.pdf [PDF]{J. L. Weaver}

 Journal Articles

2008

Terry J. Miller, Parvaneh Espandiari, Ron Honchel, Alan Knapton, Jun Zhang, Frank D. Sistare, Joseph P. Hanig. The utility of K6/ODC transgenic mouse as an alternative short term dermal model for carcinogenicity testing. Regulatory Toxicology and Pharmacology, Online 11/2007. 50(1): 87-97, 2/2008

2007

Espandiari P, Zhang J, Rosenzweig B, Vaidya VS, Sun J, Schnackenberg L, Herman EH, Knapton A, Beger D, Thompson K and Hanig JP.  The utility of a rodent model in detecting pediatric drug-induced nephrotoxicity.  Toxicological Sciences, Online 2007

Espandiari P, Zhang J, Schnackenberg LK, Miller TJ, Knapton A, Herman EH, Beger RD and Hanig JP.  Age-related differences in susceptibility to toxic effects of valproic acid in Rats, Journal of Applied. Toxicology.  Online 11/2007

Hasinoff B and Herman E. Dexrazoxane: how it works in cardiac and tumor cells. Is it a drug or is it a prodrug. Cardiovasc Toxicol 7:140-144, 2007.

Slikker W Jr, Zou X, Hotchkiss CE, Divine RL, Sadovova N, Twaddle NC, Doerge DR, Scallet AC, TA Patterson, J Hanig.  Ketamine-induced neuronal cell death in the perinatal rhesus monkey.  Toxicological  Sciences, Online 2007

Thompson K, Pine S, Rosenzweig B, Turpaz Y and Retief RCharacterization of the effect of sample quality on high density oligonucleotide microarray data using progressively degraded rat liver RNA. BMC Biotechnology 7:57, 2007

Zhou Y, Vaidya VS, Brown RP, Rosenzweig BA, Johnson A, Thompson KL, Zhang J,  Vakili Z, Miller T, Bonventre JV and Goering PI. Comparison of kidney injury molecule-1 and other nephrotoxicity biomarkers in urine and kidney following acute exposure to gentamicin, mercury, and chromium.  Toxicological Sciences, 101(1):159-170, 2007

2006

Guo L, Guo X, Hager J, Haje PK, Han J, Han T, Harbottle HC, Harris SC, Hatchwell C, Hauser CA, Hester S, Hong H, Hurban P, Jackson SA, Ji H, Knight CR, Kuo WP, Leclerc JE, Levy S, Li QZ, Liu C, Lui Y, Lombardi MJ, Ma Y, Magnuson SR, Maqsodi B, McDaniel T, Mei N, Myklebost O, Ning B, Novoradovskaya N, Orr MS, Osborn TW, Papallo A, Patterson TA, Perkins RG, Peters EH, Peterson R, Phillips KL, Pine PS, Zhang J, Herman EH, Robertson DG, Reily MD, Knapton A, Ratajczak HV, Rifai N, Honchel R, Blanchard KT, Stoll RE, Sistare FD.: (2006) Mechanisms and biomarkers of cardiovascular injury induced by phosphodiesterase inhibitor III SK&F 95654 in the spontaneously hypertensive rat. Toxicol Pathol. 34 152-63. http://taylorandfrancis.metapress.com/openurl.asp?genre=article&id=doi:10.1080/01926230600588562

Han T, Melvin CD, Shi L, Branham WS, Moland CL, Pine PS, Thompson KL and Fuscoe JC.  Improvement in the reproducibility and accuracy of DNA microarray quantification by optimizing hybridization conditions. BMC Bioinformatics, 7 (Suppl 2): S17, 2006

Herman E, Zhang J, Knapton A, Lipshultz SE, Rifai N, Sistare F.  Serum cardiac troponin T as a biomarker for acute myocardial injury induced by low doses of isoproterenol in rats.  Cardiac Toxicol 6:211-221, 2006

Leighton JK, Brown P, Ellis A, Harlow P, Harrouk W, Pine PS, Robison T, Rosario L and Thompson, K.  (2006) Workgroup Report: Review of genomic data based on experience with mock submissions: View of the CDER Pharmacology Toxicology Nonclinical Pharmacogenomics Subcommittee.  Environ. Health Perspect. 114: 573-578. 

Pusztai L, Qian F, Ren H, Rosen M, Rosenzweig BA, Samaha RR, Schena M,  Schroth GP, Shchegrova S, Smith DD, Staedtler F, Su Z, Sun H, Szallasi Z, tezak Z, Thierry-Mieg D, Thompson KL, Tikhonova I, Turpaz Y, Vallanat B, Van C, Walker SJ, Wang SJ, Wang Y, Wolfinger R, Wong A, Wu J, Xiaco, Slikker W Jr.  The microarray Quality Control (MAQC) project shows inter- and intraplatform reproducibility of gene expression measurements.  Nat. Biotechol. 2006 Sep 8;24(9): 1151-1161

Sadrieh N and Espandiari P. Nanotechnology and the FDA: What are the scientific and regulatory considerations for products containing nanomaterials?  Nanotechnology Law & Business, 3(Issue 3), 2006

Shi L, Reid LH, Jones WD, Shippy R, Warrington JA,  Baker SC, Collins PJ, deLongueville F, Kawasaki ES, Lee KY, Luo Y, Sun YA, Willey JC, Setterquist RA, Fischer GM, Tong W, Dragon YP, Dix DJ, Frueh Fw, Goodsaid FM, Herman D, Jensen RV, Johnson CD, Lobenhofer EK, Puri RK, Scherf U, Thierry-Mieg J, Wang C, Wilson M, Wolber PK, Zhang L, Amur S, Bao W,Barbacioru CC, Lucas AB, Bertholet V, Boysen C, Bromley B, Brown D, Brunner A, Canales R, Cao XM, Cebula TA, Chen JJ, Cheng J, Chu TM, Chudin E, Corson J, Corton JC, Croner LJ, Davies C, Deng X, Dorris D, Eklund AC, Fan XH, Fang H, Fulmer-Smentek S, Fuscoe JC, Gallagher K, Ge W, Guo L, Guo X, Hager J, Haje PK, Han J, Han T, Harbottle HC, Harris SC, Hatchwell C, Hauser CA, Hester S, Hong H, Hurban P, Jackson SA, Ji H, Knight CR, Kuo WP, Leclerc JE, Levy S, Li QZ, Liu C, Lui Y, Lombardi MJ, Ma Y, Magnuson SR, Maqsodi B, McDaniel T, Mei N, Myklebost O, Ning B, Novoradovskaya N, Orr MS, Osborn TW, Papallo A, Patterson TA, Perkins RG, Peters EH, Peterson R, Phillips KL, Pine PS, Pusztai L, Qian F, Ren H, Rosen M, Rosenzweig BA, Samaha RR, Schena M,  Schroth GP, Shchegrova S, Smith DD, Staedtler F, Su Z, Sun H, Szallasi Z, tezak Z, Thierry-Mieg D, Thompson KL, Tikhonova I, Turpaz Y, Vallanat B, Van C, Walker SJ, Wang SJ, Wang Y, Wolfinger R, Wong A, Wu J, Xiaco, Slikker W Jr.  The microarray Quality Control (MAQC) project shows inter- and intraplatform reproducibility of gene expression measurements.  Nat. Biotechol. 2006 Sep 8;24(9): 1151-1161

Shippey R, Fulmer-Smentek S, Jensen RV, Jones WD, Wolber PK, Johnson CD, Pine PS, Boysen C, Guo X, Chudin E, Sun YA, Willey JC, Thierry-Mieg J, Thierry-Mieg D, Setterquist RA, Wilson M, Lucas AB, Novoradovskaya N, Papallo A, Turpaz Y, Baker SC, Warrington JA, Shi L, and Herman D.  Using RNA sample titrations to assess microarray platform performance and normalization techniques.  National Biotechnology. 24(9): 1123-1131 (2006)

Shippey R, Fulmer-Smentek S, Jensen RV, Jones WD, Wolber PK, Johnson CD, Pine PS, Boysen C, Guo X, Chudin E, Sun YA, Willey JC, Thierry-Mieg J, Thierry-Mieg D, Setterquist RA, Wilson M, Lucas AB, Novoradovskaya N, Papallo A, Turpaz Y, Baker SC, Shi L, Reid LH, Jones WD, Shippy R, Warrington JA,  Collins PJ, deLongueville F, Kawasaki ES, Lee KY, Luo Y, Sun YA, Willey JC, Setterquist RA, Fischer GM, Tong W, Dragon YP, Dix DJ, Frueh Fw, Goodsaid FM, Herman D, Jensen RV, Johnson CD, Lobenhofer EK, Puri RK, Scherf U, Thierry-Mieg J, Wang C, Wilson M, Wolber PK, Zhang L, Amur S, Bao W,Barbacioru CC, Lucas AB, Bertholet V, Boysen C, Bromley B, Brown D, Brunner A, Canales R, Cao XM, Cebula TA, Chen JJ, Cheng J, Chu TM, Chudin E, Corson J, Corton JC, Croner LJ, Davies C, Deng X, Dorris D, Eklund AC, Fan XH, Fang H, Fulmer-Smentek S, Fuscoe JC, Gallagher K, Ge W, Thomas T, Thomas K, Sadrieh N, Savage N, Adair P, and Bronaugh R.  Research strategies for safety evaluation of nanomaterials, Part VII: Evaluating consumer exposures to nanoscale materials, Toxicological Sciences 91: 14-19, 2006  http://dx.doi.org/doi:10.1093/toxsci/kfj129

Treye Thomas, Karluss Thomas, Nakissa Sadrieh, Nora Savage, Patricia Adair, and Robert Bronaugh.  Research Strategies for Safety Evaluation of Nanomaterials, Part VII: Evaluating Consumer Exposures to Nanoscale Materials, Toxicological Sciences Vol 91: 14-19 (2006).  http://dx.doi.org/doi:10.1093/toxsci/kfj129

Wang C, Sadovova N, Hotchkiss C, Fu X,  Scallet AC, Patterson TA, Hanig J, Paule MG And Slikker W, Jr. Blockade of N-methyl-d-aspartate (Nmda) Receptors by Ketamine Produces Loss of Postnatal Day 3 (Pnd-3) Monkey Frontalcortical Neurons in Culture. Toxicological Sciences 91: 192-201, 2006 http://dx.doi.org/doi:10.1093/toxsci/kfj144

Zhang J, Herman EH, Robertson DG, Reily MD, Knapton A, Ratajczak HV, Rifai N, Honchel R, Blanchard KT, Stoll RE, Sistare FD.: (2006) Mechanisms and biomarkers of cardiovascular injury induced by phosphodiesterase inhibitor III SK&F 95654 in the spontaneously hypertensive rat. Toxicol Pathol. 34 152-63. http://taylorandfrancis.metapress.com/openurl.asp?genre=article&id=doi:10.1080/01926230600588562

2005

Akerman GS, Rosenzweig BA, Domon OE, Tsai CA, Bishop ME, McGarrity LJ, Macgregor JT, Sistare FD, Chen JJ, and Morris SM. Alterations in gene expression profiles and the DNA-damage response in ionizing radiation-exposed TK6 cells. Environ Mol Mutagen 45(2-3): 188-205 (2005)

Ferguson, SA, Cisneros FJ, Gough B, Hanig JP and Berry KJ. Chronic oral treatment with 13-cis-retinoic acid(isotretinoin) or all-trans-retinoic acid does not alter depression-like behaviors in rats. Toxicological Sciences, 87:451-459 (2005) http://dx.doi.org/doi:10.1093/toxsci/kfi262

Kerns W, Schwartz L, Blanchard K, Burchiel S, Essayan D, Fung E, Johnson R, Lawton M, Louden C, MacGregor J, Miller F, Nagarkatti P, Robertson D, Snyder P, Thomas H, Wagner B, Ward A, Zhang J; Expert Working Group on Drug-Induced Vascular Injury. Drug-induced vascular injury: A quest for biomarkers. Toxicol Appl Pharmacol 203:62-87 (2005). http://dx.doi.org/10.1016/j.taap.2004.08.001

Sadrieh N and Brown S.  Therapies require teamwork among FDA and developers. Small Time 5(8):22-23 (2005).

Sadrieh N, Brower B, Yu L, Doub W, Straughn A, Machado S, Pelsor F, Saint Martin E, Moore T, Reepmeyer J, Toler D, Nguyenpho A, Roberts R, Schuirmann DJ, Nasr M, and Buhse L.  Stability, dose uniformity, and palatability of three counterterrorism drugs- human subject and electronic tongue studies.  Pharm. Res. 22(10):1747-1756 (2005)

Thompson KL, Rosenzweig BA, Pine PS, Retief J, Turpaz Y, Afshari CA, Hamadeh HK, Damore MA, Boedigheimer M, Blomme E, Ciurlionis R, Waring JF, Fuscoe JC, Paules R, Tucker CJ,  Fare T, Coffey EM, He Y, Collins PJ, Jarnagin K, Fujimoto S, Ganter B, Kiser G, Kaysser-Kranich T, Sina J and Sistare FD.  (2005) Use of a mixed tissue RNA design for performance assessments on multiple microarray formats.  Nucleic Acids Res. 33:e187 (http://nar.oxfordjournals.org/cgi/reprint/33/22/e187?ijkey=rXZSZ7eyRqlHP8T&keytype=ref

Wang C, Sandocovan, Fu X, Schmued L, Scallet A, Hanig J and Slikker W. The Role of N-methyl-d-aspartate receptor in ketamine-induced apoptosis in rat forebrain culture, Neuroscience 132: 967-977 (2005). http://dx.doi.org/10.1016/j.neuroscience.2005.01.053

Weaver JL, Chapdelaine JM,  Descotes J, Germolec D, Holsapple M, House R,  Lebrec H,  Meade J, Pieters R, Hastings KL, and Dean JH. Evaluation of a lymph node proliferation assay for its ability to detect pharmaceuticals with potential to cause immune-mediated drug reactions.  J. Immunotoxicol. 2:11-20 (2005).

Weaver JL, Hastings KL.  Clinical relevance of preclinical testing for allergic side effects. Bala, S.,  Toxicology 209:195-200 (2005). http://dx.doi.org/10.1016/j.tox.2004.12.030

Weaver JL, Tsutsui N, Hisada S, Vidal JM, Spanhaak S, Sawada J, Hastings KL, Laan V, van Loveren H, Kawabata TT, Sims J, Durham SK, Fueki O, Matula TI, Kusunoki H,  Ulrich P, Nakamura K. A survey of industry practices on the immunotoxicology evaluation of pharmaceuticals.   J. Immunotoxicol. 2:171-180 (2005).

Wouters KA, Kremer LCM, Miller TL, Herman EH, Lipshultz SE. (2005) Protecting against anthracycline-induced myocardial damage: A review of the most promising strategies. Br J Haematol. 131:561-78.

Yang Y, Pine S,  Davis H, Grunberg N, Phillips P, Faustino P, Lyon R, and Yu L, and Hanig J.   Determination of plasma and brain levels of isotretinoin in mice by high-performance liquid chromatography.   J Pharm Biomed Anal