Most of the top 35 pharmaceutical companies are members of the Simcyp™ Consortium. The FDA, EMA, PMDA and other regulators use the Simcyp Simulator.
Simcyp™ Simulator: Your Gateway to Predicting Drug Performance in Virtual Populations
Welcome to the Simcyp Simulator, the pinnacle of pharmaceutical innovation! Our platform stands as the beacon of excellence in the realm of physiologically based pharmacokinetics (PBPK), empowering the industry with unparalleled capabilities in various critical domains:
The Simcyp Simulator accurately predicts drug behavior within the human body, aiding in various stages of drug development. This includes determining optimal dosing for first-in-human trials, optimizing clinical study designs, evaluating new drug formulations, predicting drug-drug interactions, and conducting virtual bioequivalence analyses.
The simulator incorporates extensive libraries on demographics, developmental physiology, and drug elimination pathways, along with advanced mechanistic organ models and compound files. It integrates in vitro data with in vivo outcomes to support informed decision-making and offers virtual population simulations reflecting diverse demographics, ethnicities, and disease states.
Version 23 Enhancements:
Regulatory Alignment:
- Meet new regulatory guidelines, covering pH-dependent drug-drug interactions and therapeutic proteins.
Key Features and Applications:
- Predictive Capabilities: Assess drug PK in diverse populations for first-in-human dosing, study optimization, formulation evaluation, and drug-drug interaction predictions.
- Wide-ranging Applicability: Suitable for various drug types, including small molecules, biologics, ADCs, bispecifics, and oligonucleotides.
Innovative Simulator Components:
- Organ-Specific Models: Utilize advanced PBPK models for precise predictions across multiple organs.
- Demographic and Physiological Databases: Simulate diverse populations with varying demographics, ethnicities, and disease states.
Applications Across Drug Development Cycle:
- Early Predictions and Dosing: Facilitate early PK predictions, first-in-human dosing, and compound risk analysis.
- Special Population Dosing: Tailor dosing for pediatric, elderly, and impaired populations.
- Formulation and Bioequivalence Studies: Support virtual bioequivalence assessments and formulation optimization.
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.
Delivering on the promise of PBPK
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 375+ label claims.
The Fundamentals of PBPK Models: How to Build Compounds, Populations and More
Developing effective PBPK models necessitates precise system and drug-specific parameters, along with advanced tools. The Simcyp Simulator plays a crucial role in Model-Informed Drug Development (MIDD) by generating virtual populations and predicting drug disposition. Discover these two guides that demonstrate how to create PBPK models for specific populations and compounds, aiding informed decision-making in drug development.
Speed Up Drug Development for Kinase Inhibitors: Free eBook
Download our free eBook, “Waiving Clinical Studies & Accelerating Drug Development for Kinase Inhibitor (KI) Drugs,” to uncover the power of Physiologically Based Pharmacokinetic (PBPK) modeling with Simcyp™ Simulator. Learn how PBPK modeling replaces clinical studies, enables precision medicine, garners FDA recognition, predicts real-world impacts, drives breakthroughs, and explores future potential. Accelerate your drug development journey today!
Unique Capabilities—Specialized Modules
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. - Simcyp Designer
Simcyp Designer is a user friendly environment to quickly develop pharmacodynamic and/or quantitative systems pharmacology models and link them the Simcyp PBPK model and modify or expand those models. - Virtual Bioequivalence
The Virtual Bioequivalence (VBE) module facilitates running a range of common BE studies incorporating within and between subjects variability and batch to batch formulation changes. It also allows conducting BE statistical analysis, assess power of virtual BE studies and determine clinically relevant dissolution safe space.
Gaining the Simcyp Advantage through Consultancy
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 effects/bioequivalence, food effect
-
Dosing for special populations – pediatrics, elderly, organ impairment, disease conditions, ethnic differences
-
Evaluation of drug performance from extrinsic factors – smoking, alcohol
-
Novel routes of administration – dermal, inhalation, long-acting injectable, rectal, intravaginal
-
Biologics – mAbs, ADCs, other proteins, cytokine mediated DDIs
-
Virtual bioequivalence and formulations for complex generics
-
Early PK prediction, FIH dosing
