Simcyp™ PBPK Simulator

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.