Services

Consultancy and implementation of systems pharmacology and PK/PD modelling for target assessment, target/receptor occupancy, format selection, compound design, candidate selection, design and analysis of preclinical PK/PD (dose-finding, AUC, half-life, etc.) and GLP toxicology studies, first in human dose selection, and RP2D:

• In vitro and in vivo pre-clinical study design, PK and PK/PD data analysis (NCA: Cmax, AUC, half-life; and mechanistic and data-driven PK/PD modelling and simulation), and expert interpretation of results 
• Clinical pharmacology consulting on the design and conduct of studies in preclinical, translational, and all phases of clinical development, PK analysis (both non-compartmental and model-based analyses), and expert interpretation of results 
• State-of-the-art pharmacometric services such as population PK analysis, development of mechanism-based PK/PD and disease progression models, data-driven modelling and simulation, inter-species (allometric) scaling, exposure-response analyses for safety and efficacy endpoints to identify therapeutic windows and support dose selection (FIH, RP2D), and clinical trial simulation (CTS)
• Assistance with first-in-human regulatory reports, IND, BLA, etc. submissions