Kuei Meng Wu

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi request reprint Regulatory science: a special update from the United States Food and Drug Administration: Preclinical issues and status of investigation of botanical drug products in the United States
    K M Wu
    Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA
    Toxicol Lett 111:199-202. 2000
  2. ncbi request reprint Regulatory perspectives of Type II prodrug development and time-dependent toxicity management: nonclinical Pharm/Tox analysis and the role of comparative toxicology
    Kuei Meng Wu
    Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States
    Toxicology 236:1-6. 2007
  3. doi request reprint Timing of carcinogenicity studies and predictability of genotoxicity for tumorigenicity in anti-HIV drug development
    Kuei Meng Wu
    Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
    Int J Toxicol 31:211-21. 2012
  4. ncbi request reprint Complexities of the herbal nomenclature system in traditional Chinese medicine (TCM): lessons learned from the misuse of Aristolochia-related species and the importance of the pharmaceutical name during botanical drug product development
    K M Wu
    Center for Drug Evaluation and Research, FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    Phytomedicine 14:273-9. 2007
  5. doi request reprint Current regulatory toxicology perspectives on the development of herbal medicines to prescription drug products in the United States
    Kuei Meng Wu
    Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States
    Food Chem Toxicol 46:2606-10. 2008
  6. doi request reprint Current regulatory perspectives on genotoxicity testing for botanical drug product development in the U.S.A
    Kuei Meng Wu
    Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    Regul Toxicol Pharmacol 56:1-3. 2010
  7. doi request reprint Green tea extract-induced lethal toxicity in fasted but not in nonfasted dogs
    Kuei Meng Wu
    Division of Antiviral Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA
    Int J Toxicol 30:19-20. 2011
  8. ncbi request reprint Preclinical development of new drugs that enhance thyroid hormone metabolism and clearance: inadequacy of using rats as an animal model for predicting human risks in an IND and NDA
    Kuei Meng Wu
    HFD 530, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA
    Am J Ther 13:141-4. 2006
  9. ncbi request reprint Regulatory toxicology perspectives on the development of botanical drug products in the United States
    Kuei Meng Wu
    The Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20852, USA
    Am J Ther 11:213-7. 2004

Collaborators

Detail Information

Publications9

  1. ncbi request reprint Regulatory science: a special update from the United States Food and Drug Administration: Preclinical issues and status of investigation of botanical drug products in the United States
    K M Wu
    Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA
    Toxicol Lett 111:199-202. 2000
    ..In conclusion, this survey indicates that the growing public interest in botanical supplements has prompted more formal evaluation of the efficacy/safety claims of these products...
  2. ncbi request reprint Regulatory perspectives of Type II prodrug development and time-dependent toxicity management: nonclinical Pharm/Tox analysis and the role of comparative toxicology
    Kuei Meng Wu
    Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States
    Toxicology 236:1-6. 2007
    ..Both approaches could significantly facilitate secondary and tertiary review processes during IND development of a prodrug or NME...
  3. doi request reprint Timing of carcinogenicity studies and predictability of genotoxicity for tumorigenicity in anti-HIV drug development
    Kuei Meng Wu
    Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
    Int J Toxicol 31:211-21. 2012
    ..Additionally, both carcinogenicity and genotoxicity data show significant correlations, which provide useful insights into issues involving these 2 important areas of toxicological investigations...
  4. ncbi request reprint Complexities of the herbal nomenclature system in traditional Chinese medicine (TCM): lessons learned from the misuse of Aristolochia-related species and the importance of the pharmaceutical name during botanical drug product development
    K M Wu
    Center for Drug Evaluation and Research, FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    Phytomedicine 14:273-9. 2007
    ..It is hoped that by following the pharmaceutical name, toxic herbs can be effectively identified and substitution or adulteration avoided...
  5. doi request reprint Current regulatory toxicology perspectives on the development of herbal medicines to prescription drug products in the United States
    Kuei Meng Wu
    Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States
    Food Chem Toxicol 46:2606-10. 2008
    ..It is anticipated that through a proactive two-way communication between the Agency and the sponsor, toxicological development of botanical drug product can be significantly facilitated...
  6. doi request reprint Current regulatory perspectives on genotoxicity testing for botanical drug product development in the U.S.A
    Kuei Meng Wu
    Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    Regul Toxicol Pharmacol 56:1-3. 2010
    ..The information presented indicates that the sponsors of botanical INDs have increasingly recognized the importance of genotoxicity information and may have prioritized its acquisition in their strategic drug development programs...
  7. doi request reprint Green tea extract-induced lethal toxicity in fasted but not in nonfasted dogs
    Kuei Meng Wu
    Division of Antiviral Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA
    Int J Toxicol 30:19-20. 2011
    ....
  8. ncbi request reprint Preclinical development of new drugs that enhance thyroid hormone metabolism and clearance: inadequacy of using rats as an animal model for predicting human risks in an IND and NDA
    Kuei Meng Wu
    HFD 530, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA
    Am J Ther 13:141-4. 2006
    ..Under such conditions, IND and NDA sponsors of drugs exhibiting this activity profile should be encouraged to use alternative animal species for toxicity exploration to provide a more meaningful human risk prediction...
  9. ncbi request reprint Regulatory toxicology perspectives on the development of botanical drug products in the United States
    Kuei Meng Wu
    The Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20852, USA
    Am J Ther 11:213-7. 2004
    ..It is anticipated that through a proactive 2-way communication between the Agency and the sponsor, toxicological development of botanical drug product can be significantly facilitated...