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