Most of the top 40 pharmaceutical companies are members of the Simcyp™ Consortium. The FDA, EMA, PMDA and other regulators use the Simcyp Simulator.
Certara’s Simcyp PBPK Simulator is the go-to technology for physiologically based pharmacokinetic (PBPK) modeling and simulation. PBPK modeling enables extrapolation of relevant endpoints from in vitro and clinical trial data and the answering of myriad ‘what if’ drug development questions. The Simcyp Simulator has benefited from 20+ years of development, collaborating with the world’s leading pharma companies, academic institutions and global regulators.
- The Simulator includes a full PBPK model with extensive libraries on demographics, developmental physiology and the ontogeny of drug elimination pathways;
- An unmatched body of science, the Simulator includes 10 advanced mechanistic organs, 25 sub-populations, and 100+ compound files for use by member companies;
- Links in vitro data to in vivo absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetic / pharmacodynamic (PK/PD) outcomes to explore clinical scenarios and support drug development decisions;
Simcyp PBPK models describes the drug concentration in different organs, behavior across different body tissues, and thus helps to inform clinical trial design, first-in-human dosing, formulation design, dose differentiation for special populations, and predictions related to potential drug-drug interactions. Simcyp is for small and large molecule drugs.
New Version 20 includes new models for maternal health, virtual bioequivalence to attain biowaivers, and analysis of long-acting injectable drugs. The expanded Simcyp Biologics Simulator enables scientists to model a wider range of biologic modalities to accelerate drug development. The Simcyp Biologics Simulator is now available as standalone software.
Analyze complex in vitro data using whole cell, tissue samples and solid dosage samples to assess the exposure, metabolism, transport, and dissolution/solubility of drugs
Simcyp™ Animal is a PBPK modeling platform for rat, dog, mouse and monkey, used to explain drug behavior that would be difficult to obtain via in vivo experimentation.
In the last decade, PBPK modeling and simulation has soared in its use and applicability—Simcyp, working with its industry, academic and regulatory partners has led the way. The Simcyp Simulator is employed across the drug development cycle:
- For early pharmacokinetic determination of first-in-human dosing and to answer other translational questions;
- Leveraged to support strategic decision-making, the Simulator provides valuable information for designing clinical trials, to reduce trial size and complexity and to obtain clinical trial waivers;
- The Simulator quantitatively evaluates and predicts drug-drug interactions (DDIs) involving drug-metabolizing enzymes and membrane transporters, to evaluate PK variability as a function of ethnicity, organ impairment, and pharmacogenomics;
- It predicts dosing recommendations for different populations of patients, including pediatrics, geriatrics, ethnicities, organ impairment.
Adopted by 11 global regulatory agencies including the US FDA, Japan’s PMDA, UK’s MHRA and others, the Simcyp Simulator has been used to inform scores of drugs, replacing the need for clinical trials and providing prescribing information for approximately 250 label claims.
Beyond the work within the Consortium, the Simcyp team has collaborated with other organizations and funded its own research to develop unique modules. While connected to the Simulator, they require additional and optional licensing.
Specialized modules are:
- Simcyp Pediatric
Simcyp® Pediatric Simulator is the industry’s most sophisticated technology for modeling drug performance and determining dosing in neonates, infants, and children. The Simulator contains extensive libraries on demographics, developmental physiology, and the ontogeny of drug elimination pathways.
- Simcyp Cardiac Safety Simulator (CSS)
CSS is a systems biology-driven modeling and simulation-based platform for the assessment of the pro-arrhythmic potency of drugs, new chemical entities, and other xenobiotics within the targeted clinical population. It enables early assessment of cardiac liability and is used for both pre-clinical and clinical assessment of cardiac risk.
- Simcyp Long Acting Injectable (LAI)
LAI drug delivery provides advantages for specific drugs and patient types, including reduced toxicity, reduced dosing frequency and enhanced compliance. Simcyp’s LAI module is used to design experiments, narrow down promising formulation candidates, determine animal studies or clinical trials and fine-tune formulation based on study details.
- Simcyp Lactation
Unfortunately, dosing information for pregnant and lactating women is generally not available on the drug label. Simcyp has been focused on this topic, looking at women’s health across the gestational cycle. Simcyp lactation module predicts drug exposure in the mother and the milk to be given to the child, allowing for proper dosing of this fragile population.
Innovative mid and smaller biopharmaceutical companies can gain the advantages of the Simcyp PBPK Simulator outside of joining the Simcyp Consortium or attaining licenses. Simcyp has a team of experienced and highly credentialed individuals that support smaller organizations on a per-project basis via consultancy. Generally, we begin with a feasibility assessment to determine if the appropriate data is available to conduct the modeling & simulation with a full project to follow.
Example projects include:
- Drug-drug interaction simulations – perpetrator and victim
- Absorption modelling – formulation differences, food effect, virtual bioequivalence
- Dosing for special populations – pediatrics, elderly, organ impairment, disease conditions, ethnic differences
- Novel routes of administration – dermal, inhalation, long-acting injectable
- Biologics – mAbs, ADCs, cytokine mediated DDIs
- Early PK prediction, FIH dosing