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Expertise: Consulting 222 results
Antibody-drug conjugates (ADCs) represent one of the most dynamic areas of oncology drug development. By combining monoclonal antibodies, cytotoxic payloads, and chemical linkers, these therapies are designed to selectively target tumor cells while limiting systemic exposure. Each component contributes to...
As drug development becomes increasingly complex, Model-Informed Drug Development (MIDD) has emerged as a critical strategy for optimizing clinical trial design, enhancing regulatory engagement, and accelerating development timelines. While population pharmacokinetic/pharmacodynamic (PopPK/PD) modeling is a central component of MIDD, sponsors...
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eTMF Site and Country Quality Reviews
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In vitro / in vivo correlation (IVIVC) is a scientific approach used to establish predictive relationships between laboratory-based drug release profiles (in vitro) and pharmacokinetic behavior in humans (in vivo). By linking dissolution data with plasma concentration profiles, IVIVC helps...
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Catherine Gatza, Ph.D.
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Seth DePuy, Ph.D.
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