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Publications on Genomics


FDA Genomics Group Publications (2002-present) 

 

2014

 
Horenstein RB, Madabushi R, Zineh I, Yerges-Armstrong LM, Peer CJ, Schuck RN, Figg WD, Shuldiner AR, Pacanowski MA. Effectiveness of clopidogrel dose escalation to normalize active metabolite exposure and antiplatelet effects in CYP2C19 poor metabolizers. J Clin Pharmacol. 2014 Apr 7. doi: 10.1002/jcph.293. [PubMed]
 
Pacanowski MA, Leptak C, Zineh I. Next-generation medicines: past regulatory experience and considerations for the future. Clin Pharmacol Ther. 2014 Mar;95(3):247-9. doi: 10.1038/clpt.2013.222. Review. [PubMed]
 
Mummaneni P, Shord SS. Epigenetics and oncology. Pharmacotherapy. 2014 May;34(5):495-505. doi: 10.1002/phar.1408. Epub 2014 Mar 11.[ PubMed]


2013

Zineh I, Pacanowski M, Woodcock J. Pharmacogenetics and coumarin dosing--recalibrating expectations. N Engl J Med. 2013 Dec 12;369(24):2273-5. doi: 10.1056/NEJMp1314529.  [PubMed]

 
Lewis JP, Stephens SH, Horenstein RB, O'Connell JR, Ryan K, Peer CJ, Figg WD, Spencer SD, Pacanowski MA, Mitchell BD, Shuldiner AR. The CYP2C19*17 variant is not independently associated with clopidogrel response. J Thromb Haemost. 2013 Sep;11(9):1640-6. doi: 10.1111/jth.12342 [PubMed]
 
Charlab R, Zhang L. Pharmacogenomics: historical perspective and current status. Methods Mol Biol. 2013;1015:3-22. doi: 10.1007/978-1-62703-435-7_1. [PubMed]
 
Racoosin JA, Roberson DW, Pacanowski MA, Nielsen DR.New evidence about an old drug--risk with codeine after adenotonsillectomy. N Engl J Med. 2013 Jun 6;368(23):2155-7. doi: 10.1056/NEJMp1302454. Epub 2013 Apr 24. [PubMed ]

Lewis JP, Horenstein RB, Ryan K, O'Connell JR, Gibson Q, Mitchell BD, Tanner K, Chai S, Bliden KP, Tantry US, Peer CJ, Figg WD, Spencer SD, Pacanowski MA, Gurbel PA, Shuldiner AR.
The functional G143E variant of carboxylesterase 1 is associated with increased clopidogrel active metabolite levels and greater clopidogrel response. Pharmacogenet Genomics. 2013 Jan;23(1):1-8. doi: 10.1097/FPC.0b013e32835aa8a2. [PubMed]  

Conrado DJ, Rogers HL, Zineh I, Pacanowski MA.
Consistency of drug-drug and gene-drug interaction information in US FDA-approved drug labels. Pharmacogenomics. 2013 Jan;14(2):215-23. doi: 10.2217/pgs.12.203. [PubMed]

Maliepaard M, Nofziger C, Papaluca M, Zineh I, Uyama Y, Prasad K, Grimstein C, Pacanowski M, Ehmann F, Dossena S, Paulmichl M Pharmacogenetics in the evaluation of new drugs: a multiregional regulatory perspective. Nat Rev Drug Discov. 2013 Feb 1;12(2):103-15. [PubMed]


2012

Pacanowski MA, Zineh I.
Pharmacogenomic strategies in drug safety. Drug Discovery Today: Ther Strategies. 2012. 

Rogers HL, Bhattaram A, Zineh I, Gobburu J, Mathis M, Laughren TP, Pacanowski M.
CYP2D6 genotype information to guide pimozide treatment in adult and pediatric patients: basis for the US Food and Drug Administration's new dosing recommendations. Clin Psychiatry. 2012 Sep;73(9):1187-90. doi: 10.4088/JCP.11m07572. [PubMed]

Pacanowski M, Amur S, Zineh I.
New genetic discoveries and treatment for hepatitis C. JAMA. 2012 May 9;307(18):1921-2. [PubMed]

Liu J, Jadhav PR, Amur S, Fleischer R, Hammerstrom T, Lewis L, Naeger L, O'Rear J, Pacanowski M, Robertson S, Seo S, Soon G, Birnkrant D.
Response guided telaprevir therapy in prior relapsers?: the role of bridging data from treatment-naïve and experienced subjects. Hepatology. 2012 Apr 6. doi: 10.1002/hep.25764. [PubMed]

Amur S, Parekh A, Mummaneni P.
Sex differences and genomics in autoimmune diseases. J Autoimmun. 2012 May;38(2-3):J254-65. Epub 2011 Dec 27. Review. [PubMed]
 

2011

Zineh I, Mummaneni P, Lyndly J, Amur S, La Grenade LA, Chang SH, Rogers H, Pacanowski MA.
Allopurinol pharmacogenetics: assessment of potential clinical usefulness. Pharmacogenomics. 2011 Dec;12(12):1741-9. [PubMed]

Zineh I, Huang SM.
Biomarkers in drug development and regulation: a paradigm for clinical implementation of personalized medicine.
Biomark Med. 2011 Dec;5(6):705-13. [PubMed]

Bashaw ED, Huang SM, Coté TR, Pariser AR, Garnett CE, Burckart G, Zhang L, Men AY, Le CD, Charlab R, Gobburu JV, Lesko LJ.
Clinical pharmacology as a cornerstone of orphan drug development. Nat Rev Drug Discov. 2011 Oct 31;10(11):795-6. doi: 10.1038/nrd3595. [PubMed]

Laughren TP, Gobburu J, Temple RJ, Unger EF, Bhattaram A, Dinh PV, Fossom L, Hung HM, Klimek V, Lee JE, Levin RL, Lindberg CY, Mathis M, Rosloff BN, Wang SJ, Wang Y, Yang P, Yu B, Zhang H, Zhang L, Zineh I.
Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant. J Clin Psychiatry. 2011 Sep;72(9):1166-73. [PubMed]

Haas DW, Kuritzkes D, Ritchie MD, Amur S, Gage BF, Maartens G, Masys D, Fellay J, Phillips E, Ribaudo HJ, Freedberg KA, Petropoulos C, Manolio TA, Gulick RM, Haubrich R, Kim P, Dehlinger M, Abebe R, Telenti A; Workshop, Pharmacogenomics - A Path Towards Personalized HIV Care.
Pharmacogenomics of HIV therapy: summary of a workshop sponsored by the National Institute of Allergy and Infectious Diseases. HIV Clin Trials. 2011 Sep-Oct;12(5):277-85. [PubMed]

Woodcock J, Buckman S, Goodsaid F, Walton, MK, Zineh I.
Qualifying biomarkers for use in drug development: a US Food and Drug Administration overview.
Expert Opin Med Diagn. 2011 Sep;5(5):369-74.

Zineh I, Pacanowski MA.
Pharmacogenomics in the assessment of therapeutic risks versus benefits: inside the United States Food and Drug Administration
. Pharmacotherapy. 2011 Aug;31(8):729-35. [PubMed]

Arasappan D, Tong W, Mummaneni P, Fang H, Amur S.
Meta-analysis of lupus microarray data using a novel pathway-based approach
. BMC Medicine. 2011 May 30;9:65-74. [PubMed

Grimstein C, Bai JPF.
Individualizing therapy of monoclonal antibodies and fusion proteins: emerging potential in the age of personalized medicine. Therapeutic Delivery. 2011 Mar;2(3):369-81. [PubMed]

Afdhal NH, McHutchison JG, Zeuzem S, Mangia A, Pawlotsky JM, Murray JS, Shianna KV, Tanaka Y, Thomas DL, Booth DR, Goldstein DB; Pharmacogenetics and Hepatitis C Meeting Participants.
Hepatitis C pharmacogenetics: state of the art in 2010.
Hepatology. 2011 Jan;53(1):336-45. doi: 10.1002/hep.24052. [PubMed]


2010

Sapsford KE, Tezak Z, Kondratovich M, Pacanowski MA, Zineh I, Mansfield E.
Biomarkers to improve the benefit/risk balance for approved therapeutics: a US FDA perspective on personalized medicine.
Ther Deliv. 2010;1:631–41. [PubMed]

Surh LC, Pacanowski MA, Haga SB, Hobbs S, Lesko LJ, Gottlieb S, Papaluca-Amati M, Patterson SD, Hughes AR, Kim MJ, Close SL, Mosteller M, Zineh I, Dechairo B, Cohen NA.
Learning from product labels and label changes: how to build pharmacogenomics into drug-development programs
. Pharmacogenomics. 2010 Dec;11(12):1637-47. [PubMed

Shaw PM, Zineh I.
Generating and weighing evidence in drug development and regulatory decision making: 5th US FDA-DIA workshop on pharmacogenomics
. Pharmacogenomics. 2010 Dec;11(12):1629-35. [PubMed]

Lesko LJ, Zineh I, Huang SM.
What is clinical utility and why should we care?
Clin Pharmacol Ther. 2010 Dec; 88(6):729-33. [PubMed]  

Freedman AN, Sansbury LB, Figg WD, Potosky AL, Weiss Smith SR, Khoury MJ, Nelson SA, Weinshilboum RM, Ratain MJ, McLeod HL, Epstein RS, Ginsburg GS, Schilsky RL, Liu G, Flockhart DA, Ulrich CM, Davis RL, Lesko LJ, Zineh I, Randhawa G, Ambrosone CB, Relling MV, Rothman N, Xie H, Spitz MR, Ballard-Barbash R, Doroshow JH, Minasian LM.
Cancer pharmacogenomics and pharmacoepidemiology: setting a research agenda to accelerate translation. J Natl Cancer Inst. 2010 Nov 17;102(22):1698-705. Epub 2010 Oct 13. [PubMed]

Amur S, Zineh I, Abernethy DR, Huang SM, Lesko LJ.
Pharmacogenomics and adverse drug reactions (ADRs). Personalized Medicine. 2010;7(6):633-42 

Tesch G, Amur S, Schousboe JT, Siegel, JN, Lesko LJ, Bai JPF.
Success achieved and challenges ahead in translating biomarkers into clinical applications
. AAPS J. 2010 Sep;12(3):243-53. [PubMed

Hinman LM, Carl KM, Spear BB, Salerno RA, Becker RL, Abbott BM, Kelly JF, Mansfield E, Katz RG, Harper C, Day SP, Pacanowski MA, Pignato W.
Development and regulatory strategies for drug and diagnostic co-development. Pharmacogenomics. 2010 Dec;11(12):1669-75. [PubMed

Shi L, Campbell G, Jones WD, et al.
The MicroArray
Quality Control (MAQC)-II study of common practices for the development and validation of microarray-based predictive models. Nat Biotechnol. 2010 Aug;28(8):827-38. Epub 2010 Jul 30. [PubMed]

Goodsaid FM, Amur S, Aubrecht J, Burczynski ME, Carl K, Catalano J, Charlab R, Close S, Cornu-Artis C, Essioux L, Fornace AJ Jr, Hinman L, Hong H, Hunt I, Jacobson-Kram D, Jawaid A, Laurie D, Lesko L, Li HH, Lindpaintner K, Mayne J, Morrow P, Papaluca-Amati M, Robison TW, Roth J, Schuppe-Koistinen I, Shi L, Spleiss O, Tong W, Truter SL, Vonderscher J, Westelinck A, Zhang L, Zineh I.
Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact. Nat Rev Drug Discov. 2010 Jun;9(6):435-45. [PubMed]  

Dieterle F, Sistare F, Goodsaid F, Papaluca M, Ozer JS, Webb CP, Baer W, Senagore A, Schipper MJ, Vonderscher J, Sultana S, Gerhold DL, Phillips JA, Maurer G, Carl K, Laurie D, Harpur E, Sonee M, Ennulat D, Holder D, Andrews-Cleavenger D, Gu YZ, Thompson KL, Goering PL, Vidal JM, Abadie E, Maciulaitis R, Jacobson-Kram D, Defelice AF, Hausner EA, Blank M, Thompson A, Harlow P, Throckmorton D, Xiao S, Xu N, Taylor W, Vamvakas S, Flamion B, Lima BS, Kasper P, Pasanen M, Prasad K, Troth S, Bounous D, Robinson-Gravatt D, Betton G, Davis MA, Akunda J, McDuffie JE, Suter L, Obert L, Guffroy M, Pinches M, Jayadev S, Blomme EA, Beushausen SA, Barlow VG, Collins N, Waring J, Honor D, Snook S, Lee J, Rossi P, Walker E, Mattes W.
Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium. 
Nat Biotechnol. 2010 May;28(5):455-62. [PubMed

Sistare FD, Dieterle F, Troth S, Holder DJ, Gerhold D, Andrews-Cleavenger D, Baer W, Betton G, Bounous D, Carl K, Collins N, Goering P, Goodsaid F, Gu YZ, Guilpin V, Harpur E, Hassan A, Jacobson-Kram D, Kasper P, Laurie D, Lima BS, Maciulaitis R, Mattes W, Maurer G, Obert LA, Ozer J, Papaluca-Amati M, Phillips JA, Pinches M, Schipper MJ, Thompson KL, Vamvakas S, Vidal JM, Vonderscher J, Walker E, Webb C, Yu Y.
Towards consensus practices to qualify safety biomarkers for use in early drug development.
Nat Biotechnol. 2010 May;28(5):446-54. [PubMed]

Goodsaid F, Papaluca M.
Evolution of biomarker qualification at the health authorities.
Nat Biotechnol. 2010 May;28(5):441-3. [PubMed]

Woosley RL, Myers RT, Goodsaid F.
The Critical Path Institute's approach to precompetitive sharing and advancing regulatory science.
Clin Pharmacol Ther. 2010 May;87(5):530-3. [PubMed]

Zineh I, Woodcock J.
The clinical pharmacogeneticist: an emerging regulatory scientist at the US Food and Drug Administration.
Hum Genomics. 2010 Apr;4(4):221-5. [PubMed

Hong H, Goodsaid F, Shi L, Tong W.
Molecular biomarkers: a US FDA effort.
Biomark Med. 2010 Apr;4(2):215-25. [PubMed]

Hong H, Shi L, Su Z, Ge W, Jones WD, Czika W, Miclaus K, Lambert CG, Vega SC, Zhang J, Ning B, Liu J, Green B, Xu L, Fang H, Perkins R, Lin SM, Jafari N, Park K, Ahn T, Chierici M, Furlanello C, Zhang L, Wolfinger RD, Goodsaid F, Tong W.
Assessing sources of inconsistencies in genotypes and their effects on genome-wide association studies with HapMap samples.
Pharmacogenomics J. 2010 Apr 6. [PubMed]

Lesko LJ, Zineh I.
DNA, drugs and chariots: on a decade of pharmacogenomics at the US FDA.
Pharmacogenomics. 2010 Apr;11(4):507-12. [PubMed]

Burckart GJ, Amur S.
Update on the clinical pharmacogenomics of organ transplantation.
Pharmacogenomics. 2010 Feb;11(2):227-36. [PubMed]

     

2009 

O'Brien TJ, Goodsaid F, Plack M, Harralson A, Harrouk W, Hales TG, Mandel HG, Perry DC, Kennedy K, Sarvazyan N, Chiappinelli VA.
Development of an undergraduate pharmacogenomics curriculum.
Pharmacogenomics. 2009 Dec;10(12):1979-86. [PubMed]

Goodsaid FM, Blank M, Dieterle F, Harlow P, Hausner E, Sistare F, Thompson A, Vonderscher J.
Novel biomarkers of acute kidney toxicity.
Clin Pharmacol Ther. 2009 Nov;86(5):490-6. Epub 2009 Aug 26. [PubMed]

Huang SM, Zhao H, Lee JI, Reynolds K, Zhang L, Temple R, Lesko LJ.
Therapeutic protein-drug interactions and implications for drug development.
Clin Pharmacol Ther. 2010 Apr;87(4):497-503. Epub 2010 Mar 3. [PubMed]

Thompson KL and Pine PS.
Comparison of the diagnostic performance of human whole genome microarrays using mixed-tissue RNA reference samples.
Toxicol Lett. 2009 Apr 10;186(1):58-61. [PubMed]

Bai JP, Lesko LJ, Burckart GJ.
Understanding the genetic basis for adverse drug effects: the calcineurin inhibitors.
Pharmacotherapy. 2010 Feb;30(2):195-209. [PubMed]

Kim MJ, Huang SM, Meyer UA, Rahman A, Lesko LJ.
A regulatory science perspective on warfarin therapy: a pharmacogenetic opportunity.
J Clin Pharmacol. 2009 Feb;49(2):138-46. Review. [PubMed]

Hinman L, Spear B, Tsuchihashi Z, Kelly J, Bross P, Goodsaid F, Kalush F.
Drug-diagnostic codevelopment strategies: FDA and industry dialog at the 4th FDA/DIA/PhRMA/PWG/BIO Pharmacogenomics Workshop.
Pharmacogenomics. 2009 Jan;10(1):127-136. [PubMed]

Surh LC, Lesko LJ, Hobbs S, Gutman S, Minasian LM, Della Pasqua OE, Austin MJ, Lu K.
Fit-for-purpose pharmacogenomic biomarkers in drug development: a project team case study with 'what-ifs'.
Pharmacogenomics. 2009 Jan;10(1):137-47. [PubMed]

Frueh FW, Salerno RA, Lesko LJ, Hockett RD.
4th US FDA-Drug Information Association pharmacogenomics workshop, held 10-12 December, 2007.
Pharmacogenomics. 2009 Jan;10(1):111-5. [PubMed

 

2008  

Goodsaid FM.
Modulation of clopidogrel pharmacodynamic response.
Pharmacotherapy. 2008 Dec; 28(12):1423-4. [PubMed]

Pine PS, Boedigheimer M, Rosenzweig BA, Turpaz Y, He YD, Delenstarr G, Ganter B, Jarnagin K, Jones W D, Reid LH, and Thompson KL. 
Use of diagnostic accuracy as a metric for evaluating laboratory proficiency with microarray assays using mixed tissue RNA reference samples
Pharmacogenomics. 2008 Nov;9(11):1753-63. [PubMed]

Hardy BJ, Séguin B, Goodsaid F, Jimenez-Sanchez G, Singer PA, Daar AS.
The next steps for genomic medicine: challenges and opportunities for the developing world.
Nat Rev Genet. 2008 Oct;9 Suppl 1:S23-7. [PubMed]

S-M Huang and R Temple.
Is this the drug or dose for you? impact and consideration of ethnic factors in global drug development, regulatory review, and clinical practice (PDF - 551KB). 
Clin Pharmacol Ther. 84:287-294 (2008). [PubMed]

To read more articles on pharmacoethnicity from the September 2008 issue of Clinical Pharmacology & Therapeutics, visit http://www.nature.com/clpt.

LJ Lesko.
The critical path of warfarin dosing: finding an optimal dosing strategy using pharmacogenetics (PDF - 142KB). 
Clin Pharmacol Ther. 84:301-303 (2008). [PubMed]

Yasuda S, Zhang L, Huang SM.
The role of ethnicity in variability in response to drugs: focus on clinical pharmacology studies (PDF - 378KB)
Clin Pharmacol Ther. 2008 Sep;84(3):417-23. [PubMed]
Erratum (PDF - 65KB)Clin Pharmacol Ther. 2009 Dec;86(6):683

Zhang J, Snyder RD, Herman EH, Knapton A, Honchel R, Miller T, Espandiari P, Goodsaid FM, Rosenbulum IY, Hanig JP, Sistare FD, Weaver JL.
Histopathology of Vascular Injury in Sprague-Dawley Rats Treated with Phosphodiesterase IV Inhibitor SCH 351591 or SCH 534385.
Toxicol Pathol. 2008 Sep 5. [PubMed]

Weaver JL, Snyder R, Knapton A, Herman EH, Honchel R, Miller T, Espandiari P, Smith R, Gu YZ, Goodsaid FM, Rosenblum IY, Sistare FD, Zhang J, Hanig J.
Biomarkers in peripheral blood associated with vascular injury in Sprague-Dawley rats treated with the phosphodiesterase IV inhibitors SCH 351591 or SCH 534385.
Toxicol Pathol. 2008;36(6):840-9. Epub 2008 Sep 5. [PubMed]

Frueh FW, Amur S, Mummaneni P, Epstein RS, Aubert RE, Deluca TM, Verbrugge RR, Burckart GJ, Lesko LJ.
Pharmacogenomic biomarker information in drug labels approved by the United States food and drug administration: prevalence of related drug use.
Pharmacotherapy. 2008 Aug;28(8):992-8. [PubMed]

Shi L, Jones WD, Jensen RV, Harris SC, Perkins RG, Goodsaid FM, Guo L, Croner LJ, Boysen C, Fang H, Qian F, Amur S, Bao W, Barbacioru CC, Bertholet V, Cao XM, Chu TM, Collins PJ, Fan XH, Frueh FW, Fuscoe JC, Guo X, Han J, Herman D, Hong H, Kawasaki ES, Li QZ, Luo Y, Ma Y, Mei N, Peterson RL, Puri RK, Shippy R, Su Z, Sun YA, Sun H, Thorn B, Turpaz Y, Wang C, Wang SJ, Warrington JA, Willey JC, Wu J, Xie Q, Zhang L, Zhang L, Zhong S, Wolfinger RD, Tong W.
The balance of reproducibility, sensitivity, and specificity of lists of differentially expressed genes in microarray studies.
BMC Bioinformatics. 2008 Aug 12;9 Suppl 9:S10. [PubMed]

Boedigheimer MJ, Wolfinger RD, Bass MB, Bushel PR, Chou JW, Cooper M, Corton JC, Fostel J, Hester S, Lee JS, Liu F, Liu J, Qian H-R, Quackenbush J, Pettit S, and Thompson KL. 
Sources of variation in baseline gene expression levels from toxicogenomics study control animals across multiple laboratories. BMC Genomics. 2008 Jun 12;9:285. [PubMed]

Shashi Amur, Felix Frueh, Lawrence Lesko and Shiew-Mei Huang.
Integration and use of biomarkers in drug development, regulation and clinical practice: a US regulatory perspective (PDF - 570KB).
Biomarkers in Medicine, June 2008; Vol. 2, No. 3, Pages 305-311 (doi:10.2217/17520363.2.3.305). [PubMed]

Huang SM, Strong JM, Zhang L, Reynolds KS, Nallani S, Temple R, Abraham S, Habet SA, Baweja RK, Burckart GJ, Chung S, Colangelo P, Frucht D, Green MD, Hepp P, Karnaukhova E, Ko HS, Lee JI, Marroum PJ, Norden JM, Qiu W, Rahman A, Sobel S, Stifano T, Thummel K, Wei XX, Yasuda S, Zheng JH, Zhao H, Lesko LJ.
New era in drug interaction evaluation: US Food and Drug Administration update on CYP enzymes, transporters, and the guidance process.
J Clin Pharmacol. 2008 Jun;48(6):662-70. Epub 2008 Mar 31. [PubMed]

Sansone SA, Rocca-Serra P, Brandizi M, Brazma A, Field D, Fostel J, Garrow AG, Gilbert J, Goodsaid F, Hardy N, Jones P, Lister A, Miller M, Morrison N, Rayner T, Sklyar N, Taylor C, Tong W, Warner G, Wiemann S; Members of the RSBI Working Group.
The first RSBI (ISA-TAB) workshop: "can a simple format work for complex studies?"
OMICS. 2008 Jun;12(2):143-9. [PubMed

Goodsaid FM, Frueh FW, Mattes W.
Strategic paths for biomarker qualification.
Toxicology. 2008 Mar 20;245(3):219-23. Epub 2008 Jan 6. Review. [PubMed]

Burckart GJ, Amur S, Goodsaid FM, Lesko LJ, Frueh FW, Huang SM, Cavaille-Coll MW.
Qualification of biomarkers for drug development in organ transplantation.
Am J Transplant. 2008 Feb;8(2):267-70. Epub 2007 Dec 18. [PubMed]

Altar CA, Amakye D, Bounos D, Bloom J, Clack G, Dean R, Devanarayan V, Fu D, Furlong S, Hinman L, Girman C, Lathia C, Lesko L, Madani S, Mayne J, Meyer J, Raunig D, Sager P, Williams SA, Wong P, Zerba K.
A prototypical process for creating evidentiary standards for biomarkers and diagnostics.
Clin Pharmacol Ther. 2008 Feb;83(2):368-71. Epub 2007 Dec 19. [PubMed]

Gage BF, Lesko LJ.
Pharmacogenetics of warfarin: regulatory, scientific, and clinical issues.
J Thromb Thrombolysis. 2008 Feb;25(1):45-51. Epub 2007 Oct 1. Review. [PubMed]

 
2007

Thompson KL, Pine PS, Rosenzweig BA, Turpaz Y, and Retief J. 
Characterization of the effect of sample quality on high density oligonucleotide microarray data using progressively degraded rat liver RNA.  
BMC Biotechnology.  2007 Sep 13;7:57. [PubMed

Lacaná E, Amur S, Mummaneni P, Zhao H, Frueh FW.
The emerging role of pharmacogenomics in biologics.
Clin Pharmacol Ther. 2007 Oct;82(4):466-71. Epub 2007 Aug 22. Review. [PubMed]

Lesko LJ.
Personalized medicine: elusive dream or imminent reality?
Clin Pharmacol Ther. 2007 Jun;81(6):807-16. [PubMed]

Goodsaid F, Frueh FW.
Implementing the U.S. FDA guidance on pharmacogenomic data submissions.
Environ Mol Mutagen. 2007 Jun;48(5):354-8. [PubMed]

Goodsaid F, Frueh F.
Biomarker qualification pilot process at the US Food and Drug Administration.
AAPS J. 2007 Mar 23;9(1):E105-8. [PubMed]

Buckman, S, Huang, S-M, Murphy S.
Medical Product Development and Regulatory Science for the 21st Century: The Critical Path Vision and Its Impact on Health Care. 
Clin Pharmacol Ther. 2007 Feb; 81(2): 141-144. [PubMed]

Orr MS, Goodsaid F, Amur S, Rudman A, Frueh FW.
The experience with voluntary genomic data submissions at the FDA and a vision for the future of the voluntary data submission program.  
Clin Pharmacol Ther. 2007 Feb;81(2):294-7. [PubMed]

  

2006

Guo L, Lobenhofer EK, Wang C, Shippy R, Harris SC, Zhang L, Mei N, Chen T, Herman D, Goodsaid FM, Hurban P, Phillips KL, Xu J, Deng X, Sun YA, Tong W, Dragan YP, Shi L.
Rat toxicogenomic study reveals analytical consistency across microarray platforms.
Nat Biotechnol. 2006 Sep;24(9):1162-9. [PubMed]

Shi L, Reid LH, Jones WD, Shippy R, Warrington JA, Baker SC, Collins PJ, de Longueville F, Kawasaki ES, Lee KY, Luo Y, Sun YA, Willey JM, Setterquist RA, Fischer GM, Tong W, Dragan YP, Dix DJ, Frueh FW, Goodsaid FM, Herman D, Jensen RV, Johnson CD, Lobenhofer EK, Puri RK, Schrf U, Thierry-Mieg J, Wang C, Wilson M, Wolber PK, Zhang L, Slikker W Jr, Shi L, Reid LH.
MAQC Consortium. The MicroArray Quality Control (MAQC) project shows inter- and intraplatform reproducibility of gene expression measurements.
Nat Biotechnol. 2006 Sep;24(9):1151-61. [PubMed]

Canales RD, Luo Y, Willey JC, Austermiller B, Barbacioru CC, Boysen C, Hunkapiller K, Jensen RV, Knight CR, Lee KY, Ma Y, Maqsodi B, Papallo A, Peters EH, Poulter K, Ruppel PL, Samaha RR, Shi L, Yang W, Zhang L, Goodsaid FM.
Evaluation of DNA microarray results with quantitative gene expression platforms.
Nat Biotechnol. 2006 Sep;24(9):1115-22. [PubMed]

Goodsaid F, Frueh F.
Process map proposal for the validation of genomic biomarkers
Pharmacogenomics. 2006 Jul;7(5):773-82. [PubMed]

Orr MS.
Toxicogenomics and Cross-Species Biomarker Discovery: Applications in Drug Discovery and Safety Assessment.
Toxicology Mechanisms and Methods. 16:79–87, 2006. [PubMed

Hinman HLM, Huang S-M, Hackett J, Kock WH, Love PY, Pennello G, Torres-Cabassa AT, Webster C.  
The drug diagnostic co-development concept paper: Commentary from the 3rd FDA-DIA-PWG-PhRMA-BIO Pharmacogenomics Workshop. 
The Pharmacogenomics Journal. 2006 (6):375–380. doi:10.1038/sj.tpj.6500392; published online 2 May 2006. [PubMed]  

Huang, S-M, Goodsaid, F, Rahman, A, Frueh, F, and Lesko LJ.
Application of Pharmacogenomics in Clinical Pharmacology
Toxicology Mechanisms and Methods. 16: 89-99, 2006. [PubMed]  

  

2005

Andersson T, Flockhart DA, Goldstein DB, Huang SM, Kroetz DL, Milos PM, Ratain MJ, Thummel K.
Drug-metabolizing enzymes: evidence for clinical utility of pharmacogenomic tests.
Clin Pharmacol Ther. 2005 Dec;78(6):559-81. [PubMed]

Baker SC, Bauer SR, Beyer RP, et. al.
The External RNA Controls Consortium: a progress report.
Nat Methods. 2005 Oct;2(10):731-4. [PubMed]

Frueh FW, Goodsaid F, Rudman A, Huang S-M, Lesko LJ.
The Need for Education in Pharmacogenomics: a regulatory perspective.
Pharmacogenomics Journal. 2005 5(4):218-20. [PubMed]

Harper CC, Philip R, Robinowitz M, Gutman SI.
FDA perspectives on pharmacogenetic testing.
Expert Rev Mol Diagn. 2005 Sep 5(5):643-8. [PubMed]

Thompson, K.L., Rosenzweig, B.A., Pine, P.S., Retief, J., Turpaz, Y., Afshari, C.A., Hamadeh, H.K., Damore, M.A., Boedigheimer, M., Blomme, E., Ciurlionis, R., Waring, J.F., Fuscoe, J.C., Paules, R., Tucker, C.J., Fare, T., Coffe, E.M., He, Y., Collins, P.J., Jarnagin, K., Fujimoto, S., Ganter, B., Kiser, G., Kaysser-Kranich,T., Sina, J. and Sistare, F.D.
Use of a mixed tissue RNA design for performance assessments on multiple microarray formats.
Nucleic Acids Research. 2005 33(22):e187. [PubMed]

Shi L, Tong W, Fang H, Scherf U, Han J, Puri RK, Frueh FW, Goodsaid FM, Guo L, Su Z, Han T, Fuscoe JC, Xu ZA, Patterson TA, Hong H, Xie Q, Perkins RG, Chen JJ, Casciano DA. 
Cross-platform comparability of microarray technology: intra-platform consistency and appropriate data analysis procedures are essential.  
BMC Bioinformatics. 2005 Jul 15;6 Suppl 2:S12. [PubMed]

Shi L, Tong W, Su Z, Han T, Han J, Puri RK, Fang H, Frueh FW, Goodsaid FM, Guo L, Branham WS, Chen JJ, Xu ZA, Harris SC, Hong H, Xie Q, Perkins RG, Fuscoe JC.
Microarray scanner calibration curves: characteristics and implications.  
BMC Bioinformatic. 2005 Jul 15;6 Suppl 2:S11. [PubMed]

Xie, H-G, Frueh, FW.
Pharmacogenomics steps toward personalized medicine (PDF - 1MB).  
Personalized Medicine. 2005 2(4):325-337.  

  

2004

Shi L, Tong W, Goodsaid F, Frueh FW, Fang H, Han T, Fuscoe JC, Casciano DA.
QA/QC: challenges and pitfalls facing the microarray community and regulatory agencies
Expert Rev Mol Diagn. 2004 4(6):761-77. [PubMed]

Frueh FW, Huang SM, Lesko LJ.
Regulatory acceptance of toxicogenomics data
Environ Health Perspect. 2004 112(12):A663-4. [PubMed]

Lesko LJ, Woodcock J.
Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective.
Nature Reviews Drug Discovery. 2004 3(9):763-9. [PubMed]

Leighton JK, DeGeorge J, Jacobson-Kram D, MacGregor J, Mendrick D, Worobec A.
Pharmacogenomic data submissions to the FDA: non-clinical case studies
Pharmacogenomics. 2004 5(5):507-11. [PubMed]

Ruaño G, Collins JM, Dorner AJ, Wang S-J, Guerciolini R, Huang S-M.
Pharmacogenomic data submissions to the FDA: clinical pharmacology case studies
Pharmacogenomics. 2004 5(5):513-7. [PubMed]

Salerno RA, Lesko LJ.
Pharmacogenomic data: FDA voluntary and required submission guidance
Pharmacogenomics. 2004 5(5):503-5. [PubMed]

Salerno RA, Lesko LJ.
Pharmacogenomics in drug development and regulatory decision-making: the Genomic Data Submission (GDS) proposal
Pharmacogenomics. 2004 5(1):25-30. [PubMed]

Trepicchio WL, Williams GA, Essayan D, Hall ST, Harty LC, Shaw PM, Spear BB, Wang SJ, Watson ML.
Pharmacogenomic data submissions to the FDA: clinical case studies
Pharmacogenomics. 2004 5(5):519-24. [PubMed]

Frueh FW, Gurwitz D.
From pharmacogenetics to personalized medicine: a vital need for educating health professionals and the community
Pharmacogenomics. 2004 5(5):571-9. [PubMed]

  

2003

Lesko LJ, Salerno RA, Spear BB, Anderson DC, Anderson T, Brazell C, Collins J, Dorner A, Essayan D, Gomez-Mancilla B, Hackett J, Huang SM, Ide S, Killinger J, Leighton J, Mansfield E, Meyer R, Ryan SG, Schmith V, Shaw P, Sistare F, Watson M, Worobec A.
Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: report of the first FDA-PWG-PhRMA-DruSafe Workshop
J Clinical Pharmacology. 2003 43(4):342-58. [PubMed]

  

2002

Lesko LJ, Woodcock J.
Pharmacogenomic-guided drug development: regulatory perspective
The Pharmacogenomics Journal. 2002 2(1):20-4. [PubMed]

Petricoin EF 3rd, Hackett JL, Lesko LJ, Puri RK, Gutman SI, Chumakov K, Woodcock J, Feigal DW Jr, Zoon KC, Sistare FD.
Medical applications of microarray technologies: a regulatory science perspective
Nature Genetics. 2002 32 Suppl:474-9. [PubMed]