A Best Practice Framework for Applying PBPK Modeling to Pediatric Drug Development

Pediatric PBPK models have broad application in the drug development process and are being used increasingly to optimize and replace clinical studies.  However, the approach has yet to become fully integrated in regulatory submissions. Emerging data support an expanded integration of the PBPK model informed approach in regulatory guidances on pediatrics. Best practice standards are … Continued

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

Using Simcyp-guided ADME Biomarker Discovery to Prospectively Identify Patients at High Risk of Drug Toxicity

As novel molecular targets are being continuously discovered and new treatments developed, oncology is one of the biggest therapeutic areas in precision medicine. In particular, new targeted anti-cancer medications that are taken orally, such as the protein kinase inhibitors (KIs), are ideal candidates for model-informed precision dosing (MIPD) technologies.1 One of these technologies is called physiologically-based … Continued

New Tools Support Developing Better TB Drugs

Tuberculosis (TB)—caused by infection with the mycobacterium Mycobacterium tuberculosis—is one of the top 10 leading causes of death worldwide with a total of 1.8 million people dying from the disease in 2015. TB is also the leading cause of death in HIV-infected individuals. TB usually attacks the lungs but can infect any part of the … Continued

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