Traditional toxicology methods, using in vivo animal testing, is an unrealistic approach to predict chemical risk assessment. Mechanistic modeling and simulation tools such as PBPK and QST can expedite toxicological screening, support the prioritization for testing compounds that merit greater study, and reduce unnecessary animal testing.
Precision dosing is a crucial cornerstone of precision medicine that will provide patients the most efficacious medications with minimum probability of adverse events. Model-informed precision dosing, using quantitative modeling and simulation approaches, such as PBPK and NLME, can improve precision dosing in clinical care.
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Modeling and simulation can help guide critical decisions around dosing and toxicity, efficacy and mechanism of action, clinical trial design and cohort selection, and commercial probability of success as compared with existing therapies or others in development.
QSP models are inherently complex and difficult to use in a clinical setting. Rigorous model reduction methods alleviate the complexity, bolster the use of QSP models for valuable gains, resulting in the extraction of a practical useable model from biological understandings.
Mounting healthcare and R&D costs, high drug attrition rates leading to decreased numbers of new molecular entity approvals, and growing demands from regulators and payers indicate that a paradigm shift is needed to improve efficiency and productivity across the drug development continuum.
Certara’s Phoenix Technology Services team helped Arvinas integrate D360 Express with McNeil’s Assay Capture and Analysis System to facilitate structure-activity relationship analysis and save time.
The Certara team helped develop a quantitative framework that bridges the disciplines of pharmacology, epidemiology, and health economics to support meaningful dialogue between industry, regulators, and payers.
Scientists from Certara’s Strategic Consulting division helped Alios Biopharma develop a novel drug to treat respiratory syncytial virus (RSV) infection in infants.
Certara’s due diligence/asset evaluation teams are comprised of drug development and commercialization experts who advise on acquiring or investing in emerging biopharma companies.