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General Drug Development Strategy & Practice
General Drug Development Strategy & Practice
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A002: A Comparative Review of Study Population & Dose Recommendations for In Vivo Bioequivalence Studies With Pharmacokinetic Endpoints Between FDA & EMA Guidances
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021: Strategic & Quantitative Recommendations on Bioanalytical Cross-Validation Experiment Design from a Clinical Pharmacology Perspective
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022: Clinical Evaluation of the Effect of Aficamten on QT/QTc Interval in Healthy Participants
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023: FDA & EMA Regulatory Recommendations on Fed Bioequivalence Study in Healthy Subjects vs Patients for Generic Drug Development
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