Effective dose selection and therapeutic monitoring hinge on understanding pharmacokinetics (PK) and pharmacodynamics (PD). This is especially critical for narrow therapeutic index drugs, biologics, and oncology products.
Develop models representing drug distribution across body compartments to predict concentration-time profiles.
Perform NCA to estimate pharmacokinetic parameters without assuming specific compartmental models.
Simulate relationships between dosing regimens, drug exposure, and therapeutic responses.
Employ artificial intelligence to improve the accuracy and efficiency of model fitting processes.
Reduces Phase I/II uncertainty, supports rational dose selection, bridges gaps in pediatric/geriatric labeling, and underpins labeling negotiations.