At the ISSX 27th North American Meeting, themed “Back to the Future: DMPK Foundations and New Concepts,” Certara will demonstrate how its biosimulation platforms and strategic expertise help researchers understand, predict, and optimize pharmacokinetics and drug metabolism across diverse therapeutic modalities.
Leveraging platforms such as Simcyp® Simulator for physiologically based pharmacokinetic (PBPK) modeling, Certara helps teams predict human PK from preclinical and in vitro data, evaluate drug–drug interaction potential, assess variability across patient populations, and de-risk development decisions earlier in the pipeline.
Visit us to learn how our solutions support confident, model-informed strategies from discovery through clinical development.
Discover the industry’s largest scientist-curated database for assessing drug interactions and safety
Trusted by 200+ pharmaceutical and biotech companies, as well as regulatory agencies, Certara’s Drug Interaction Database (DIDB®) provides unparalleled access to qualitative and quantitative human in vitro and clinical data. By incorporating information on extrinsic and intrinsic factors such as co-medications, excipients, food products, natural products, organ impairment, and genetics, DIDB® enables informed decision-making and supports the development of safer, more effective therapies.
Retrieve information using 70+ pre-formulated queries
Optimize and validate PBPK models and static predictions
支持药品说明书建议制定
Calculate clinical DDI risk using static prediction models and generate submission-ready reports
Quickly identify relevant concomitant medications
Gain insights beyond DDIs
Learn more about Certara’s innovative early development approach
Our cross-funtional approach emphasizes operational efficiency with a dedicated program lead to reduce complexity for biotech and pharma copmanies while ensuring continous, scalable coverage.
Target product profile (TPP) and development strategy – develop a product strategy by assessing competition, viability, pricing, market access and regulations.
IND-enabling/FIH planning, design and regulatory strategy – develop functional plans, drug development strategies and study designs to ensure TPP alignment.
IND/FIH-enabling execution and reporting – oversee drug development, non-clinical studies, vendor management, DMPK analyses and translational modeling
IND authoring and submission – prepare and submit regulatory documents, including FIH protocol, Investigator Brochure and IND/CTA filings.
FIH execution/reporting – guide CRO selection, manage study execution, analyze data, and prepare for the next development phase.
Ask our experts about your most complex DDI situations
With unique and multi-disciplinary expertise in DDIs, Certara’s Center of Excellence in Drug Interaction Science paves the way for leading experts across multiple teams to work in concert and solve event the most complex DDI scenarios form early development to regulatory approval.
