Predicting how a drug product will behave in vivo (e.g., accounting for gastric pH, food effects, population variability, etc.) is a central challenge across drug development, whether for a new molecule or a generic. Generics carry an added constraint: reproducing a reference product’s performance without seeing its formulation and clearing a narrow bioequivalence bar under tighter timelines and thinner margins than innovator programs allow.
Model-informed formulation development (MIFD) offers a mechanistic, data-driven path through these challenges. In this webinar, we’ll present the latest features in Simcyp® Biopharmaceutics V25 and real-world case studies applying MIFD.
Key learning objectives:
- Receive an overview of Simcyp Biopharmaceutics, Certara’s software platform for small molecule drug development, including recent capability updates relevant to formulation strategy and biowaiver support
- Learn how mechanistic PBPK modeling was applied in a recent Molecular Pharmaceutics publication to evaluate pH-modifying excipient effects and inform formulation design decisions aimed at mitigating pH-mediated drug-drug interactions
- Understand the role of self-buffering nature of the drugs (free forms and salts), the mechanisms by which pH-modifying excipients overcome elevated pH effects of ARAs, and the role of buffers
- Learn the factors that need consideration when developing pH-DDI mitigating formulations using either salt forms or pH-modifying excipients
Speakers
Siri Kalyan Chirumamilla
Associate Principal Scientist
David B. Turner, PhD
Senior Scientific Advisor & Head of Mechanistic Oral Absorption Modelling
