Mei Ling Chen

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. doi request reprint Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report
    Mei Ling Chen
    Office of Pharmaceutical Science, Center forDrug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993 0002, USA
    Eur J Pharm Sci 44:506-13. 2011
  2. ncbi request reprint Lipid excipients and delivery systems for pharmaceutical development: a regulatory perspective
    Mei Ling Chen
    Office of Pharmaceutical Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993 0002, USA
    Adv Drug Deliv Rev 60:768-77. 2008
  3. ncbi request reprint A modern view of excipient effects on bioequivalence: case study of sorbitol
    M L Chen
    Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue Building 21, Rm 3644, Silver Spring, Maryland 20993 0002, USA
    Pharm Res 24:73-80. 2007
  4. ncbi request reprint Ethnic or racial differences revisited: impact of dosage regimen and dosage form on pharmacokinetics and pharmacodynamics
    Mei Ling Chen
    Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20993 0002, USA
    Clin Pharmacokinet 45:957-64. 2006
  5. doi request reprint Equivalence-by-design: targeting in vivo drug delivery profile
    Mei Ling Chen
    Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993 0002, USA
    Pharm Res 25:2723-30. 2008
  6. doi request reprint The use of drug metabolism for prediction of intestinal permeability (dagger)
    Mei Ling Chen
    Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA
    Mol Pharm 6:74-81. 2009
  7. doi request reprint Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified-release products: workshop summary report
    Mei Ling Chen
    U S Food and Drug Administration, USA
    Eur J Pharm Sci 40:148-53. 2010
  8. pmc Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified release products: workshop summary report
    Mei Ling Chen
    U S Food and Drug Administration, Silver Spring, Maryland, USA
    AAPS J 12:371-7. 2010
  9. doi request reprint Using partial area for evaluation of bioavailability and bioequivalence
    Mei Ling Chen
    Office of Pharmaceutical Science Center for Drug Evaluation and Research Food and Drug Administration, 10903 New Hampshire Avenue, Building 51, Rm 4108, Silver Spring, Maryland 20993 0002, USA
    Pharm Res 28:1939-47. 2011
  10. pmc Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report
    Mei Ling Chen
    U S Food and Drug Administration, Silver Spring, Maryland, USA
    AAPS J 13:556-64. 2011

Collaborators

Detail Information

Publications27

  1. doi request reprint Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report
    Mei Ling Chen
    Office of Pharmaceutical Science, Center forDrug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993 0002, USA
    Eur J Pharm Sci 44:506-13. 2011
    ....
  2. ncbi request reprint Lipid excipients and delivery systems for pharmaceutical development: a regulatory perspective
    Mei Ling Chen
    Office of Pharmaceutical Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993 0002, USA
    Adv Drug Deliv Rev 60:768-77. 2008
    ..Implications in the regulatory determination of pharmaceutical equivalence, bioequivalence and therapeutic equivalence are also illustrated...
  3. ncbi request reprint A modern view of excipient effects on bioequivalence: case study of sorbitol
    M L Chen
    Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue Building 21, Rm 3644, Silver Spring, Maryland 20993 0002, USA
    Pharm Res 24:73-80. 2007
    ..To examine the effect of common excipients such as sugars (sorbitol versus sucrose) on bioequivalence between pharmaceutical formulations, using ranitidine and metoprolol as model drugs...
  4. ncbi request reprint Ethnic or racial differences revisited: impact of dosage regimen and dosage form on pharmacokinetics and pharmacodynamics
    Mei Ling Chen
    Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20993 0002, USA
    Clin Pharmacokinet 45:957-64. 2006
    ....
  5. doi request reprint Equivalence-by-design: targeting in vivo drug delivery profile
    Mei Ling Chen
    Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993 0002, USA
    Pharm Res 25:2723-30. 2008
    ..Critical variables can be identified to serve as in vitro markers or biomarkers for mapping the desired drug delivery profile in vivo. A multidisciplinary approach may be necessary to develop these markers for characterization of iDDPs...
  6. doi request reprint The use of drug metabolism for prediction of intestinal permeability (dagger)
    Mei Ling Chen
    Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA
    Mol Pharm 6:74-81. 2009
    ..g., > or =90%). The extent of drug metabolism may be useful in supporting permeability classification under certain circumstances...
  7. doi request reprint Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified-release products: workshop summary report
    Mei Ling Chen
    U S Food and Drug Administration, USA
    Eur J Pharm Sci 40:148-53. 2010
    ....
  8. pmc Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified release products: workshop summary report
    Mei Ling Chen
    U S Food and Drug Administration, Silver Spring, Maryland, USA
    AAPS J 12:371-7. 2010
    ....
  9. doi request reprint Using partial area for evaluation of bioavailability and bioequivalence
    Mei Ling Chen
    Office of Pharmaceutical Science Center for Drug Evaluation and Research Food and Drug Administration, 10903 New Hampshire Avenue, Building 51, Rm 4108, Silver Spring, Maryland 20993 0002, USA
    Pharm Res 28:1939-47. 2011
    ..The partial area metric is useful in PK/PD characterization as well as in the evaluation of bioavailability, bioequivalence and/or comparability...
  10. pmc Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report
    Mei Ling Chen
    U S Food and Drug Administration, Silver Spring, Maryland, USA
    AAPS J 13:556-64. 2011
    ....
  11. doi request reprint Evaluation of substrates for 90 degrees peel adhesion--a collaborative study. I. Medical tapes
    Anna M Wokovich
    Center for Drug Evaluation and Research, Food and Drug Administration, St Louis, Missouri, USA
    J Biomed Mater Res B Appl Biomater 87:105-13. 2008
    ..No substrate mimics cadaver skin for all five tapes. SS had the best ability to distinguish among the medical tapes. Overall, for quality control purposes (yielding good discrimination and precision), SS would be the optimal substrate...
  12. ncbi request reprint Bioequivalence approaches for highly variable drugs and drug products
    Sam H Haidar
    Office of Generic Drugs, Food and Drug Administration, 7500 Standish Place, Rockville, Maryland, 20855, USA
    Pharm Res 25:237-41. 2008
    ..A partial replicated-treatment design with this new data analysis methodology will thus provide a more efficient design for BE studies with highly variable drugs and drug products...
  13. ncbi request reprint Challenges and opportunities in establishing scientific and regulatory standards for determining therapeutic equivalence of modified-release products: Workshop summary report
    Mei Ling Chen
    US Food and Drug Administration, Silver Spring, Maryland
    Clin Ther 32:1704-12. 2010
    ..The metric of partial AUC was proposed for products designed to have a rapid drug action followed by sustained response...
  14. pmc Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration
    Barbara M Davit
    Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 7520 Standish Place, Metro Park North One, Rockville, Maryland 20855, USA
    AAPS J 14:915-24. 2012
    ..The approach has been implemented successfully. To date, the RSABE approach has supported four full approvals and one tentative approval of HV generic drug products...
  15. ncbi request reprint Biopharmaceutics classification system: the scientific basis for biowaiver extensions
    Lawrence X Yu
    Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Rockville, Maryland 20857, USA
    Pharm Res 19:921-5. 2002
    ..3. Use the intrinsic dissolution method for solubility classification. 4. Define an intermediate solubility class for BCS Class II drugs. 5. Include surfactants in in vitro dissolution testing...
  16. ncbi request reprint Confounding factors for sex differences in pharmacokinetics and pharmacodynamics: focus on dosing regimen, dosage form, and formulation
    Mei Ling Chen
    Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20857, USA
    Clin Pharmacol Ther 78:322-9. 2005
  17. doi request reprint Effect of altered temperature storage on the in vitro cellular uptake of liposome drug products
    Donna A Volpe
    Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    J Liposome Res 20:178-82. 2010
    ..A cell-based uptake assay may provide a means to assess changes in the functional activity of liposomes in conjunction with evaluation of their physicochemical properties in order to evaluate the stability and integrity of liposomes...
  18. doi request reprint Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products (OIPs): Workshop Summary Report
    Wallace P Adams
    Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of Generic Drugs, Rockville, Maryland, USA
    J Aerosol Med Pulm Drug Deliv 23:1-29. 2010
    ..A summary of action items for seminars and working groups to address these topics in the future is also presented...
  19. doi request reprint Evaluation of substrates for 90 degrees peel adhesion--a collaborative study. II. Transdermal drug delivery systems
    Anna M Wokovich
    Center for Drug Evaluation and Research, Food and Drug Administration, St Louis, Missouri, USA
    J Biomed Mater Res B Appl Biomater 88:61-5. 2009
    ..Differences among TDDSs were greater for SS than for HDPE, using the F statistic for testing for differences among TDDSs means as a measure of heterogeneity, thereby indicating greater discrimination by SS...
  20. ncbi request reprint Equivalence approaches
    Roger L Williams
    United States Pharmacopeia and Office of Pharmaceutical Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Rockville, MD 20852, USA
    Clin Pharmacol Ther 72:229-37. 2002
  21. ncbi request reprint Assuring quality and performance of sustained and controlled release parenterals: AAPS workshop report, co-sponsored by FDA and USP
    Diane J Burgess
    Department of Pharmaceutics, University of Connecticut, 372 Fairfield Road, Storrs, Connecticut 06269, USA
    Pharm Res 19:1761-8. 2002
    ..Recommendations were made for future workshops, meetings, and working groups in this area...
  22. ncbi request reprint Assuring quality and performance of sustained and controlled released parenterals
    Diane J Burgess
    Department of Pharmaceutics, University of Connecticut, Storrs, 06269, USA
    Eur J Pharm Sci 21:679-90. 2004
  23. ncbi request reprint Assuring quality and performance of sustained and controlled release parenterals: EUFEPS workshop report
    Diane J Burgess
    Department of Pharmaceutics, University of Connecticut, 372 Fairfield Road, Storrs, CT 06269, USA
    AAPS PharmSci 6:E11. 2004
    ..Recommendations were made for future workshops and meetings...
  24. ncbi request reprint Inhibition of autoimmune diabetes by oral administration of anti-CD3 monoclonal antibody
    Hiroki Ishikawa
    Center for Neurologic Diseases, Brigham and Women s Hospital, Harvard Medical School, Boston, Massachusetts 02115, USA
    Diabetes 56:2103-9. 2007
    ..Protection by oral anti-CD3 was transforming growth factor-beta dependent. Our results demonstrate that oral anti-CD3 is effective in the model of STZ-induced diabetes and may be a useful form of therapy for type 1 diabetes in humans...
  25. ncbi request reprint Symptom clusters in cancer patients
    Mei Ling Chen
    Graduate Institute of Nursing, Chang Gung University, 259 Wen Hwa 1st Road, Kwei Shan, Tao Yuan, Taiwan
    Support Care Cancer 14:825-30. 2006
    ..The goals of this study were to understand which cancer-related symptoms cluster together and to test the conceptual meanings of the revealed symptom clusters...
  26. ncbi request reprint Oral CD3-specific antibody suppresses autoimmune encephalomyelitis by inducing CD4+ CD25- LAP+ T cells
    Hirofumi Ochi
    Center for Neurologic Diseases, Brigham and Women s Hospital, Harvard Medical School, 77 Avenue Louis Pasteur, Boston, Massachusetts 02115, USA
    Nat Med 12:627-35. 2006
    ..These findings identify a new immunologic approach that is widely applicable for the treatment of human autoimmune conditions...
  27. pmc Assuring quality and performance of sustained and controlled release parenterals: workshop report
    Diane J Burgess
    Department of Pharmaceutics, University of Connecticut, 372 Fairfield Road, Storrs, CT 06269, USA
    AAPS PharmSci 4:E7. 2002
    ..Recommendations were made for future workshops, meetings and working groups in this area...