Already the most sophisticated technology for physiologically based pharmacokinetic modeling (PBPK), the Simcyp Simulator has added a range of new advances in its recently release (version 23). This webinar, hosted by the subject matter expert scientists at Simcyp, will share these new capabilities and review the features that have enabled the Simulator to be leveraged for in the regulatory approval of >110 novel drugs.
Highlights include:
- The addition of features to address the new regulatory guidance documents finalized in 2023.
- Expansion of Simcyp’s biologics capabilities to include antisense oligonucleotides (ASO) and silencing RNA (siRNA).
- New tools for biopharmaceutical scientists including advancements for virtual bioequivalence (oral, dermal and inhalation), and expansion of safe space parameters.
- The addition of a new mechanistic model that simulates human pharmacokinetics of suspension-based long-acting injectable (LAI) products.
- Biomarker-informed PBPK modeling for early DDI risk assessment.
Key learnings:
- Simcyp’s Role in Regulatory Approval: Discover how major pharmaceutical companies and small biotech’s have utilized Simcyp to secure regulatory approval and circumvent clinical studies for various scenarios including drug-drug interactions, pediatrics, and organ impairment.
- Simulator Advancements in Biopharmaceutics: Explore the expanded capabilities of the Simulator in biopharmaceutics and formulation development, offering a competitive edge and enabling waivers for diverse drug delivery methods.
- Regulatory Alignment in PBPK Adoption: Understand the significance of regulatory alignment in driving the adoption of Physiologically Based Pharmacokinetic (PBPK) modeling in drug discovery and development, facilitating smoother regulatory pathways.
Certara Panelists:
Masoud Jamei, SVP, Research & Development
Jean Dinh, Sr. Research Scientist
Matthew Harwood, Principal Scientist
Xian Pan, Principal Scientist
Siri Chirumamilla, Sr. Research Scientist
Felix Stader, Associate Principal Scientist