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How Safe and Innovative Are First-in-Class Drugs Approved by Health Canada: A Cohort Study

Joel Lexchin1

  • 1Professor Emeritus, School of Health Policy and Management, York University, Emergency Physician, University Health Network, Associate Professor, Department of Family and Community Medicine, University of Toronto, Toronto, ON.

Healthcare Policy = Politiques De Sante
|December 30, 2016
PubMed
Abstract

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Pharmacovigilance

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Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
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