PBPK Modeling & Simulation

Certara’s Simcyp MechDermA Model Achieves Regulatory Approval: Demonstrates Virtual Bioequivalence in Dermal Drug Development

Sebastian Polak

Demonstrating bioequivalence (BE) remains the key regulatory hurdle for generic drug approval.  However, this is a challenging process for today’s complex drugs and alternative delivery methods.  Consequently, patients lack availability of thousands of generics. This problem is especially vexing for topical drugs and trans-dermal patches. Regulatory Support for Expediting the Development of Dermal Generics The […]

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Topics: PBPK Modeling & Simulation