Research Topics
| Mei Ling ChenSummaryAffiliation: Food and Drug Administration Country: USA Publications
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Detail Information
Publications
Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary reportMei 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....
Lipid excipients and delivery systems for pharmaceutical development: a regulatory perspectiveMei 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...- A modern view of excipient effects on bioequivalence: case study of sorbitolM 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... - Ethnic or racial differences revisited: impact of dosage regimen and dosage form on pharmacokinetics and pharmacodynamicsMei 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.... - Equivalence-by-design: targeting in vivo drug delivery profileMei 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... - 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... - Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified-release products: workshop summary reportMei Ling Chen
U S Food and Drug Administration, USA
Eur J Pharm Sci 40:148-53. 2010.... 
Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified release products: workshop summary reportMei Ling Chen
U S Food and Drug Administration, Silver Spring, Maryland, USA
AAPS J 12:371-7. 2010....- Using partial area for evaluation of bioavailability and bioequivalenceMei 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... - Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary reportMei Ling Chen
U S Food and Drug Administration, Silver Spring, Maryland, USA
AAPS J 13:556-64. 2011.... - Bioequivalence approaches for highly variable drugs and drug productsSam 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... - Challenges and opportunities in establishing scientific and regulatory standards for determining therapeutic equivalence of modified-release products: Workshop summary reportMei 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... - Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug AdministrationBarbara 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... - Biopharmaceutics classification system: the scientific basis for biowaiver extensionsLawrence 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... - Evaluation of substrates for 90 degrees peel adhesion--a collaborative study. I. Medical tapesAnna 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... - Evaluation of substrates for 90 degrees peel adhesion--a collaborative study. II. Transdermal drug delivery systemsAnna 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... - Effect of altered temperature storage on the in vitro cellular uptake of liposome drug productsDonna 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... - Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products (OIPs): Workshop Summary ReportWallace 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... - Confounding factors for sex differences in pharmacokinetics and pharmacodynamics: focus on dosing regimen, dosage form, and formulationMei-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 - Equivalence approachesRoger 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 - Assuring quality and performance of sustained and controlled release parenterals: AAPS workshop report, co-sponsored by FDA and USPDiane 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... - Assuring quality and performance of sustained and controlled released parenteralsDiane J Burgess
Department of Pharmaceutics, University of Connecticut, Storrs, 06269, USA
Eur J Pharm Sci 21:679-90. 2004 - Assuring quality and performance of sustained and controlled release parenterals: EUFEPS workshop reportDiane 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... - Inhibition of autoimmune diabetes by oral administration of anti-CD3 monoclonal antibodyHiroki 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... - Symptom clusters in cancer patientsMei 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... - Oral CD3-specific antibody suppresses autoimmune encephalomyelitis by inducing CD4+ CD25- LAP+ T cellsHirofumi 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... - Assuring quality and performance of sustained and controlled release parenterals: workshop reportDiane 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...