The Simcyp Difference

The industry-leading Simcyp whole body PBPK Simulator platform is used for virtual decision-making in drug development, from early development through clinical, regulatory approval and post-marketing.  The Simcyp PBPK Simulator predicts how the drug will move through the body and how a drug is affected by other medications, ethnicity, age, genetics and disease-state.  It is used to reduce, inform and/or eliminate trials and advise on dosing for new patient cohorts.

Developed and updated over the past 20 years via the Simcyp Consortium of 35 leading biopharm companies, the Simcyp Simulator is used by our consulting team for companies of all sizes and stages of drug development.  Used by regulators for drug review, Simcyp was leveraged for the first FDA MIDD PBPK project. The Simcyp Simulator has informed dosing decision for 70+ new drugs and 200+ label claims for oncology, rare, CNS, cardiac, and other therapeutic areas.  Simcyp enabled the first and only virtual bioequivalence approval for a complex generic drug.  Additionally, the Simcyp consulting team provides regulatory support along with modeling, including routine meetings with drug agency review staff.

View 70+ Novel Drugs Informed by the Simcyp Simulator
Benefits of PBPK

PBPK is used throughout the drug life cycle to support decisions on whether, when, and how to conduct certain clinical pharmacology studies and to support dosing recommendations for product labeling. Used to support strategic decision-making, Simcyp PBPK provides valuable information for designing clinical trials and to obtain clinical trial waivers. Most important, PBPK helps answer a myriad of “what if” questions about drug performance, dosing and alternate populations that could not be answered without lengthy, expensive, logistically challenging, and sometimes ethically questionable clinical studies.

Example projects include:

  • Drug-drug interaction simulations – perpetrator and victim
  • Absorption modelling – formulation differences, 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
  • Biologics – mAbs, ADCs, cytokine mediated DDIs
  • Virtual bioequivalence and formulations for complex generics
  • Early PK prediction, FIH dosing
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The ‘Go to’ Solution for DDI Analyses

The decision is clear: Simcyp PBPK for informing and replacing drug-drug interactions studies

US FDA’s 2020 final guidance on DDI clearly makes the case for PBPK:

  • “PBPK models can predict the DDI potential of an investigational drug/and or metabolite as an enzyme substrate or enzyme perpetrator.”
  • “PBPK models verified for the mechanism of dose-dependent pharmacokinetics of the substrate can be used to support dose selection.”
  • “Because of evolving science, new uses of in silico methods to predict DDIs in lieu of clinical DDI studies are continuously being considered by the FDA. We encourage sponsors to discuss issues and considerations related to the use of in silico models with the FDA.”

Simcyp has led the evolution of PBPK in drug development, notably the advances in DDI analysis, anchoring the case studies that informed these regulatory statements.  The Simcyp Simulator, recognized as s the most sophisticated platform for the prediction of pharmacokinetic outcomes in virtual patient populations has been accepted in lieu of >200 DDI studies.

The Simcyp consulting team is organized and ready to take on your projects.

Download white paper on PBPK for DDIs
Simcyp for Special Populations

Children, elder adults, pregnant women, patients with impaired renal or liver function.  These and other sub-populations are not typically included in clinical trials, resulting in a lack of prescribing instructions in the drug label.  Further, dose recommendations typically reflect only a single factor and leave the prescriber guessing as how to integrate any information for patients with multiple health conditions.

The Simcyp Simulator combines vitro-in vivo extrapolation (IVIVE) and PBPK approaches in virtual individuals to predict drug concentration and effect on these special populations.  It integrates intrinsic and extrinsic factors, data on the drug, the system and sub-population physiology into the PBPK model to account for the multiple covariates driving PK in specific populations. Simcyp has applied this approach, shared with regulators on populations including:

  • Pediatrics, including neonates
  • Pregnant and lactating mothers
  • Geriatric populations
  • Organ impaired – kidney, liver, heart
  • Obese individuals
  • Ethnic bridging
  • Multiple disease states
Contact us for a discussion on your project
Our Team
Hannah Jones, PhD Vice President, Head of PBPK Consulting Services

Hannah has over 17 years experience in global pharmaceutical organisations, possessing a particularly strong background in PBPK and PKPD modelling, She has over 50 publications in modelling and other DMPK related topics, responsible for influencing drug research and development programs through modelling and simulation.

Masoud Jamei, PhD Senior Vice President, Simcyp Research & Development

Masoud leads teams of scientists and programmers on the design, development and implementation of various aspects of systems pharmacology including in vitro-in vivo extrapolation techniques, physiologically-based PK/PD models, and the application of top-down PopPK data analysis to PBPK models in healthy volunteer and patient populations.

Karen Rowland Yeo, PhD Senior Vice President, Client & Regulatory Strategy

Since 2002, Karen has led projects relating to the extrapolation of in vitro data to predict in vivo pharmacokinetics in humans. This has included development and implementation of the models into the Simcyp Simulator.  Her specific research interests include physiologically based pharmacokinetic modeling and prediction of drug-drug interactions.

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