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Mei-Ling Chen

Center for Drug Evaluation and Research
Food and Drug Administration

55

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2776

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Summary report of second EUFEPS/AAPS conference on global harmonization in bioequivalence

2019 European Journal of Pharmaceutical Sciences
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The Global Bioequivalence Harmonization Initiative: Summary report for EUFEPS international conference

2018 European Journal of Pharmaceutical Sciences
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Pharmacokinetics-Based Approaches for Bioequivalence Evaluation of Topical Dermatological Drug Products

2015 Clinical Pharmacokinectics
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Novel bioequivalence approach for narrow therapeutic index drugs

2015 Clinical Pharmacology & Therapeutics
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Fundamentals of Bioequivalence

2014
- Mei-Ling Chen
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Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration

2012 Aaps Journal
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Use of Partial Area under the Curve Metrics to Assess Bioequivalence of Methylphenidate Multiphasic Modified Release Formulations

2012 Aaps Journal
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The BCS, BDDCS, and Regulatory Guidances

2011 Pharmaceutical Research
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Using Partial Area for Evaluation of Bioavailability and Bioequivalence

2011 Pharmaceutical Research
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Harmonization of Regulatory Approaches for Evaluating Therapeutic Equivalence and Interchangeability of Multisource Drug Products: Workshop Summary Report

2011 Aaps Journal
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