Systems Pharmacology uses mathematics to describe the pharmacokinetics and pharmacodynamics relationship in its physiological context
Systems Pharmacology is ideally suited for the modelling of biotherapeutics PK/PD. Biotherapeutics are highly specific, target binding often has a significant impact on the pharamcokinetics and compounds are designed with a very specific and increasingly complex mode of action. This can result in highly advanced compounds with an equally complex PK/PD relationship. For biotherapeutics the enternal route of administration is not possible; instead injections or other depot approaches have to be used.
Therefore, an precise understanding of the human PK/PD is critical to devise dose and regimens that are efficacious, safe, and convenient for patients.
Taken together, a need emerges for methodologies that can quantitatively capture the PK/PD relationship and that can be used for decision making along the R&D process. Because of the intimate link between compound and target the consideration of the emerging PK/PD properties becomes relevant at the stage of selecting the target throughout the development process until phase III.