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

Prescription Drug Pricing: “The Times They Are A-Changin”

Ulrich Neumann

“Come senators, congressmen Please heed the call Don’t stand in the doorway Don’t block up the hall For he that gets hurt Will be he who has stalled” Bob Dylan recorded his iconic “The Times They Are a Changin’” in 1963; the song was released on the 1964 album by the same name. One of […]

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Topics: Evidence and Market Access