Journal of clinical pharmacologyTherapeutic EquivalencyClopidogrelHumansPlatelet Aggregation InhibitorsModels
Leveraging Model Integrated Bioequivalence (MIBE) to Address Regulatory Concerns and Waive Repeat Bioequivalence Studies-A Case Study with Clopidogrel.
Mathangi Gopalakrishnan, Adithya Karthik Bhattiprolu, Joga Gobburu, Rajkumar Boddu, Veena Kambam, Sohel Mohammed Khan, Anuj Kumar Saini, Sivacharan Kollipara
Published: 202610.1002/jcph.70142
Abstract
In recent years, model-informed strategies such as the model integrated bioequivalence (MIBE) approach have gained significance due to their ability to enable decision making, streamline drug product development, and to waive bioequivalence studies,…
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