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Genomics at FDA
Publications by FDA Staff


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[PDF] 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[PDF] Clin Pharmacol Ther 84: 301-303 (2008) [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]

Yasuda S, Zhang L, Huang SM.
The Role of Ethnicity in Variability in Response to Drugs: Focus on Clinical Pharmacology Studies. pdf[PDF], Clin Pharmacol Ther. 2008 Jul 9. [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 [PDF]
Biomarkers in Medicine, June 2008; Vol. 2, No. 3, Pages 305-311 (doi:10.2217/17520363.2.3.305)

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]

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]


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]


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

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


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]
Personalized Medicine. 2005 2(4):325-337.


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]

RuaƱo 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]


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]


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]

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Date created: August 4, 2005, updated September 9, 2008

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