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Simcyp Simulator

The Simcyp Population-based Simulator streamlines drug development through the modeling and simulation of pharmacokinetics and pharmacodynamics in virtual populations. The Simcyp Simulator is the pharmaceutical industry’s most sophisticated platform for the prediction of drug-drug interactions and pharmacokinetic outcomes in clinical populations.

Cardiac Safety Simulator

The Cardiac Safety Simulator™ (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.

Mechanistic Modeling of Antibody Drug Conjugate Pharmacokinetics

Antibody Drug Conjugates (ADCs) are constructed by attaching a small molecule drug to an antibody via a linker. The antibody selectively targets tumor cells and releases the cytotoxic drug within the cells to kill cancerous cells while sparing healthy tissue. Although some ADCs have been approved, many unanswered questions remain, such as drug-drug interactions (DDIs) and … Continued

Guiding Dose Adjustment in Pregnancy

Scientists developed a PBPK pregnancy model, implemented in the Simcyp Simulator and tested for its ability to simulate drug concentration changes over time.

Simcyp In Vitro Analysis (SIVA) Toolkit: Get the Most from Your In Vitro Data

Analysis of in vitro data from whole cell systems and dissolution studies is complex, challenging and time consuming. Yet accurate data analysis and informed data interpretation early in drug development is crucial. Existing tools have mainly been developed for broader data analysis and are not specifically designed for in vitro systems. These software tools do not readily support analysis … Continued

Recent Advances in Development and Application of Physiologically-based Pharmacokinetic (PBPK) Models: A Transition from Academic Curiosity to Regulatory Acceptance

There is a renewed surge of interest in applications of physiologically-based pharmacokinetic (PBPK) models by the pharmaceutical industry and regulatory agencies. Developing PBPK models within a systems pharmacology context allows separation of the parameters pertaining to the animal or human body (the system) from that of the drug and the study design which is essential to develop … Continued

An Integrated Approach to Mechanistically Model In Vitro Experiments and Incorporate Drug-specific Parameter Estimates within a PBPK Framework to Simulate In Vivo Drug Dissolution

In vitro dissolution testing is a critical component of drug product development programs and is often used as a surrogate for in vivo performance. Consequently, mechanistic modelling of in vitro dissolution studies and informed data interpretation early in the formulation development process is crucial. The Simcyp In Vitro (Data) Analysis (SIVA) toolkit is a standalone … Continued

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