Federico M Goodsaid

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi The Predictive Safety Testing Consortium: A synthesis of the goals, challenges and accomplishments of the Critical Path
    Federico M Goodsaid
    Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA Electronic
    Drug Discov Today Technol 4:47-50. 2007
  2. ncbi Questions and answers about the Pilot Process for Biomarker Qualification at the FDA
    Federico M Goodsaid
    Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA Electronic
    Drug Discov Today Technol 4:9-11. 2007
  3. pmc The balance of reproducibility, sensitivity, and specificity of lists of differentially expressed genes in microarray studies
    Leming Shi
    National Center for Toxicological Research, US Food and Drug Administration, 3900 NCTR Road, Jefferson, AR 72079, USA
    BMC Bioinformatics 9:S10. 2008
  4. pmc Cross-platform comparability of microarray technology: intra-platform consistency and appropriate data analysis procedures are essential
    Leming Shi
    National Center for Toxicological Research, U S Food and Drug Administration, 3900 NCTR Road, Jefferson, Arkansas 72079, USA
    BMC Bioinformatics 6:S12. 2005
  5. pmc Microarray scanner calibration curves: characteristics and implications
    Leming Shi
    National Center for Toxicological Research, U S Food and Drug Administration, 3900 NCTR Road, Jefferson, Arkansas 72079, USA
    BMC Bioinformatics 6:S11. 2005
  6. ncbi Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact
    Federico M Goodsaid
    Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US FDA, Building 51, 10903 New Hampshire Avenue, Silver Spring, Maryland 20903 002, USA
    Nat Rev Drug Discov 9:435-45. 2010
  7. ncbi Novel biomarkers of acute kidney toxicity
    F M Goodsaid
    Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 86:490-6. 2009
  8. doi Translational medicine and the value of biomarker qualification
    Federico M Goodsaid
    Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U S Food and Drug Administration FDA, Silver Spring, MD 20903, USA
    Sci Transl Med 2:47ps44. 2010
  9. doi Strategic paths for biomarker qualification
    Federico M Goodsaid
    Genomics Group, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, FDA, MD 20903 0002, United States
    Toxicology 245:219-23. 2008
  10. ncbi Implementing the U.S. FDA guidance on pharmacogenomic data submissions
    Federico Goodsaid
    Genomics Group, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20903 0002, USA
    Environ Mol Mutagen 48:354-8. 2007

Detail Information

Publications24

  1. ncbi The Predictive Safety Testing Consortium: A synthesis of the goals, challenges and accomplishments of the Critical Path
    Federico M Goodsaid
    Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA Electronic
    Drug Discov Today Technol 4:47-50. 2007
    ....
  2. ncbi Questions and answers about the Pilot Process for Biomarker Qualification at the FDA
    Federico M Goodsaid
    Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA Electronic
    Drug Discov Today Technol 4:9-11. 2007
    ..Several frequently asked questions associated with this process are presented in this paper, as well as answers reflecting the Agency's current thinking about this process.: ..
  3. pmc The balance of reproducibility, sensitivity, and specificity of lists of differentially expressed genes in microarray studies
    Leming Shi
    National Center for Toxicological Research, US Food and Drug Administration, 3900 NCTR Road, Jefferson, AR 72079, USA
    BMC Bioinformatics 9:S10. 2008
    ..The resultant variety of existing and emerging methods exacerbates confusion and continuing debate in the microarray community on the appropriate choice of methods for identifying reliable DEG lists...
  4. pmc Cross-platform comparability of microarray technology: intra-platform consistency and appropriate data analysis procedures are essential
    Leming Shi
    National Center for Toxicological Research, U S Food and Drug Administration, 3900 NCTR Road, Jefferson, Arkansas 72079, USA
    BMC Bioinformatics 6:S12. 2005
    ..Nucleic Acids Res., 31, 5676-5684, 2003), portrays a disturbingly negative picture of the cross-platform comparability, and, hence, the reliability of microarray technology...
  5. pmc Microarray scanner calibration curves: characteristics and implications
    Leming Shi
    National Center for Toxicological Research, U S Food and Drug Administration, 3900 NCTR Road, Jefferson, Arkansas 72079, USA
    BMC Bioinformatics 6:S11. 2005
    ..Microarray-based measurement of mRNA abundance assumes a linear relationship between the fluorescence intensity and the dye concentration. In reality, however, the calibration curve can be nonlinear...
  6. ncbi Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact
    Federico M Goodsaid
    Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US FDA, Building 51, 10903 New Hampshire Avenue, Silver Spring, Maryland 20903 002, USA
    Nat Rev Drug Discov 9:435-45. 2010
    ....
  7. ncbi Novel biomarkers of acute kidney toxicity
    F M Goodsaid
    Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 86:490-6. 2009
    ....
  8. doi Translational medicine and the value of biomarker qualification
    Federico M Goodsaid
    Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U S Food and Drug Administration FDA, Silver Spring, MD 20903, USA
    Sci Transl Med 2:47ps44. 2010
    ..The U.S. Food and Drug Administration has developed a regulatory process for biomarker qualification to accelerate the process by which new biomarkers are integrated in the development of therapies...
  9. doi Strategic paths for biomarker qualification
    Federico M Goodsaid
    Genomics Group, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, FDA, MD 20903 0002, United States
    Toxicology 245:219-23. 2008
    ..Active strategies for qualification include those associated with context-independent as well as context-dependent qualifications...
  10. ncbi Implementing the U.S. FDA guidance on pharmacogenomic data submissions
    Federico Goodsaid
    Genomics Group, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20903 0002, USA
    Environ Mol Mutagen 48:354-8. 2007
    ..These initiatives have contributed to the effective implementation of the Pharmacogenomics Guidance at the FDA...
  11. pmc Biomarker qualification pilot process at the US Food and Drug Administration
    Federico Goodsaid
    Genomics Group, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20903 0002, USA
    AAPS J 9:E105-8. 2007
    ..A pilot process and corresponding Biomarker Qualification Review Team have been developed to test how the FDA can work on biomarker qualification...
  12. doi Histopathology of vascular injury in Sprague-Dawley rats treated with phosphodiesterase IV inhibitor SCH 351591 or SCH 534385
    Jun Zhang
    Division of Applied Pharmacology Research HFD 910, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Toxicol Pathol 36:827-39. 2008
    ..The present study also provides a morphological and cellular basis for evaluating candidate biomarkers of drug-induced vascular injury...
  13. doi Biomarkers in peripheral blood associated with vascular injury in Sprague-Dawley rats treated with the phosphodiesterase IV inhibitors SCH 351591 or SCH 534385
    James L Weaver
    Division of Applied Pharmacology Research, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Toxicol Pathol 36:840-9. 2008
    ..The changes in these parameters showed both a dose- and time-dependent association with histopathologic changes. These biomarkers could provide an additional tool for the nonclinical and clinical evaluation of investigational compounds...
  14. ncbi QA/QC: challenges and pitfalls facing the microarray community and regulatory agencies
    Leming Shi
    US Food and Drug Administration, Center for Toxicoinformatics, Division of Systems Toxicology, National Center for Toxicological Research, HFT 020, 3900 NCTR Road, Jefferson, AR 72079, USA
    Expert Rev Mol Diagn 4:761-77. 2004
    ..These fundamental issues must be adequately addressed before microarray technology can be transformed from a research tool to clinical practices...
  15. doi Molecular biomarkers: a US FDA effort
    Huixiao Hong
    Center for Toxicoinformatics, Division of Systems Toxicology, National Center for Toxicological Research, US FDA 3900 NCTR Road, Jefferson, AR, USA
    Biomark Med 4:215-25. 2010
    ..Specific FDA programs and research projects related to molecular biomarkers are also discussed for supporting regulatory review in the future...
  16. pmc Translational biomarkers: from preclinical to clinical a report of 2009 AAPS/ACCP Biomarker Workshop
    Jane P F Bai
    Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
    AAPS J 13:274-83. 2011
    ....
  17. ncbi Rat toxicogenomic study reveals analytical consistency across microarray platforms
    Lei Guo
    National Center for Toxicological Research, US Food and Drug Administration, Jefferson, Arkansas 72079, USA
    Nat Biotechnol 24:1162-9. 2006
    ....
  18. pmc The MicroArray Quality Control (MAQC)-II study of common practices for the development and validation of microarray-based predictive models
    Leming Shi
    National Center for Toxicological Research, US Food and Drug Administration, Jefferson, Arkansas, USA
    Nat Biotechnol 28:827-38. 2010
    ..The conclusions and recommendations from MAQC-II should be useful for regulatory agencies, study committees and independent investigators that evaluate methods for global gene expression analysis...
  19. ncbi Process map proposal for the validation of genomic biomarkers
    Federico Goodsaid
    US Food and Drug Administration, Genomics Group, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 21, Room 3663, Silver Spring, MD 20903 0002, USA
    Pharmacogenomics 7:773-82. 2006
    ..A discussion on process map proposals for genomic biomarker validation can help with drafting of guidance documents for this process...
  20. ncbi Qualification of biomarkers for drug development in organ transplantation
    Gilbert J Burckart
    School of Pharmacy, University of Southern California, Los Angeles, CA, USA
    Am J Transplant 8:267-70. 2008
    ....
  21. ncbi Evaluation of DNA microarray results with quantitative gene expression platforms
    Roger D Canales
    Applied Biosystems, 850 Lincoln Centre Dr, Foster City, California 94404, USA
    Nat Biotechnol 24:1115-22. 2006
    ....
  22. ncbi Identification and measurement of genomic biomarkers of nephrotoxicity
    Federico M Goodsaid
    Department of Genetic and Molecular Toxicology, Schering Plough Research Institute, 144 Route 94, Lafayette, NJ 07871, USA
    J Pharmacol Toxicol Methods 49:183-6. 2004
    ..Genomic biomarkers can contribute to this process as indicators or predictors of toxicity. Transcript levels for genes such as the kidney injury molecule have been identified and evaluated as genomic biomarkers of nephrotoxicity...
  23. pmc Quantitative PCR deconstruction of discrepancies between results reported by different hybridization platforms
    Federico M Goodsaid
    Division of Drug Safety and Metabolism, Schering Plough Research Institute, 144 Route 94, PO Box 32, Lafayette, NJ 07848, USA
    Environ Health Perspect 112:456-60. 2004
    ..These data demonstrate the importance of using a "gold standard," such as qRT-PCR to confirm key hybridization results as well as to understand the sources of discrepancies resulting from different hybridization platforms...
  24. ncbi Genomic biomarkers of toxicity
    Federico M Goodsaid
    Schering Plough Research Institute, Department of Genetic and Molecular Toxicology, 144 Route 94, Lafayette, NJ 07871, USA
    Curr Opin Drug Discov Devel 6:41-9. 2003
    ..This review will summarize some of the publications that have achieved this transformation, and the steps that are still needed for the implementation of predictive tests derived from these genomic biomarkers of toxicity...