Children, the elderly, pregnant women, and other populations may need different doses to optimize safety and efficacy. But using conventional clinical trials to optimize dosing for different populations can be difficult for ethical and logistical reasons.
Virtual patients that vary in intrinsic (e.g., age, sex, weight, genetics) and extrinsic factors (e.g., diet and co-medications) can be used to increase understanding of how new vaccines and medicines work in different people. Using virtual patients, virtual trials can test vaccines, medicines, and combinations of medicines at different doses to increase the probability of selecting doses that maximize safety and efficacy, even before conducting clinical trials.
For 20 years, Certara and our partners have used virtual patients to accelerate bringing medicines to all patients.
Drug-drug interactions (DDIs), which occur when two or more drugs interact with each other, are a major drug development safety concern. Unmanageable DDIs have led to the withdrawal of numerous drugs. However, it’s not feasible to assess all potential DDIs in clinical studies, especially in populations like the elderly, children, and pregnant women. Furthermore, the rise in use of multiple drug therapies has been associated with an increased adverse drug event risk. DDIs are especially important to predict in the elderly since an estimated 50% of Medicare beneficiaries receive 5 or more medications.
Modeling and simulation can use in vitro observations to predict potential clinical DDIs. Certara’s Simcyp PBPK Simulator is the industry-leading platform for physiologically-based pharmacokinetic (PBPK) modeling and simulation, adopted by top global pharmaceutical companies and 11 global regulatory agencies. Simcyp PBPK models allow investigation of metabolic DDIs due to competitive enzyme inhibition, mechanism-based inhibition, enzyme induction, and polypharmacy. These models can even be used in lieu of some prospective DDI studies, saving significant time and money.
Knowing where to start is always a challenge and selecting the initial dose of an investigational drug to be administered in the first clinical study in humans is no exception. Getting it wrong could endanger the lives of the people participating in the study, as well as potentially derailing the whole development program and ruining years of work.
Our clinical pharmacology consultants can help increase the efficiency of your drug development program by giving you a better understanding of:
- The rigors and latest thinking on the part of regulators
- The optimal dosing strategy of an investigational drug to be administered in first-in- human clinical trials
- The competitive landscape and a ‘pharmacology-to-payer’ perspective
Dosing is a critical decision in testing potential therapeutics for COVID-19, because drugs affect patients differently. The dose has to be high enough to be effective but low enough to avoid toxic side effects and not waste critically-needed drugs. Likewise, determining the COVID-19 vaccine dosing strategy for special populations like children cannot be answered quickly enough through traditional development timelines.
Biosimulation can help answer these questions. Certara is contributing to more efficient therapeutic and vaccine development, supporting more than 24 COVID programs:
- Launching COVID-19 Pharmacology Resource Center to aid scientists in determining the optimal dose of therapeutics
- Developing the COVID-19 Clinical Outcomes Database (CODEx) to provide up-to-date results of clinical trials and observational studies
- Creating 27+ compound files for COVID therapeutics for the Simcyp Simulator to run virtual clinical trials and predict the risk of DDIs
- Building a Quantitative Systems Pharmacology (QSP) platform to test vaccine candidates across different patient populations
Working together, we’ll beat COVID-19 and be prepared for the next pandemic.