PBPK Modeling to Support Bioequivalence & Generic Product Approvals
Physiologically-based pharmacokinetic modeling can be used to support bioequivalence (BE) assessment of complex and locally…
CertaraNovember 12, 2024
JSCPT 2025 – The 46th Annual Scientific Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics
We’re excited to participate in JSCPT 2025 in Tokyo, The 46th Annual Scientific Meeting of…
CertaraOctober 31, 2024
Mathematical Models can Assist in Broadening use of Immuno-oncology Drugs to Treat Autoimmunity
Connecting Cancer and Autoimmunity "The dosing regimens in oncology may not directly inform the optimal…
CertaraOctober 31, 2024
RAPS Sponsored Webcast: Optimizing Pediatric Oncology Drug Development: A Comprehensive Overview
Developing safe and effective oncology medications for children presents unique challenges due to ethical considerations…
CertaraOctober 17, 2024
Using Quantitative Systems Pharmacology (QSP) Modeling for Oncology Dose Optimization
The FDA’s Project Optimus initiative aims to reform dose optimization and selection for oncology therapies…
CertaraAugust 19, 2024
Optimizing Clinical Development: Saving Time and Costs
Strategic mechanistic modeling solutions help an immunoncology biotech accelerate their clinical development of novel therapeutics.
CertaraAugust 16, 2024
Medicines that matter: Biohaven’s Nurtec™ drug development journey
In February 2020, Biohaven Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved…
CertaraAugust 15, 2024
