MBMA uses highly curated clinical trial data and pharmacology models to increase drug development productivity, quantitatively inform portfolio management, and improve clinical trial success.
Certara, the global leader in modeling and simulation, offers service focused on delivering greater precision and expanded populations in drug labels through proven methodology.
Nonlinear mixed effects models were developed to describe the relationship between cabozantinib exposure and target lesion tumor size in a phase III study of patients with progressive metastatic medullary thyroid cancer. These models used cabozantinib exposure estimates from a previously published population pharmacokinetic model for cabozantinib in cancer patients that was updated with data from … Continued
In this webinar, Dr. Marylore Chenel, director of Pharmacometrics at Servier, discussed how PBPK modeling is a tool that can help sponsors design better clinical studies. She illustrated this approach using two case studies. The first case study demonstrated how to evaluate potential drug-drug interactions (DDIs) with PBPK models and design multi-response sampling strategies using … Continued
We describe a “multistep reaction driven” evolutionary algorithm approach to de novo molecular design. Structures generated by the approach include a proposed synthesis path intended to aid the chemist in assessing the synthetic feasibility of the ideas that are generated. The methodology is independent of how the design ideas are scored, allowing multicriteria drug design … Continued
In addition to the strong business case for using biosimulation, there is also a powerful ethical case. Now that we know how biosimulation has proven to inform key drug development decisions, is it ethical to not employ these methods before enrolling patients or healthy volunteers into clinical studies?
Certara’s new consulting firm relies on modeling and simulation expertise to expedite the drug development process, as China commits to increasing innovation.
Biosimulation technology is revolutionizing the way in which the pharmaceutical industry does business and how the regulators are reviewing new drug approvals. Biosimulation leverages both empirical analysis of clinical data and mechanistic in silico approaches. The latter approach encompasses both in vitro-in vivo extrapolation (IVIVE) and physiologically-based pharmacokinetic modeling and simulation (PBPK M&S).
Quantitative systems pharmacology (QSP) sits at the interface between pharmacometric modeling and simulation, and systems biology. It uses mathematics to describe biological processes. While pharmacokinetics describes what the body does to the drug, pharmacodynamics quantifies what the drug does to the body; the pharmacological response. QSP is a mechanistic modeling approach and an emerging technology, which mathematically integrates pharmacokinetics, pharmacological response and disease progress/modulation.
Staff writer Ron Rosenberg interviewed Piet van der Graaf, PharmD, PhD, vice president of quantitative systems pharmacology at Certara and former director of XenologiQ, a QSP consultancy.
