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Satish Sharan

Center for Drug Evaluation and Research

7

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21

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Model‐Informed Drug Development for Long‐Acting Injectable Products: Summary of American College of Clinical Pharmacology Symposium

2021 Clinical pharmacology in drug development
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New Model-Based Bioequivalence Statistical Approaches for Pharmacokinetic Studies with Sparse Sampling.

2020 Aaps Journal
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Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report.

2020 Journal of Pharmaceutical Sciences
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Regulatory Science to Promote Access to Intrauterine Systems for Women in the United States.

2020 The Journal of Clinical Pharmacology
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Review of Complex Generic Drugs Delivered Through the Female Reproductive Tract: The Current Competitive Landscape and Emerging Role of Physiologically Based Pharmacokinetic Modeling to Support Development and Regulatory Decisions

2020 The Journal of Clinical Pharmacology
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An in vitro approach for evaluating the oral abuse deterrence of solid oral extended-release opioids with properties intended to deter abuse via chewing

2019 International Journal of Pharmaceutics
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Citations (4)