Impact of Quantitative Pharmacology on Drug Development

Thesuccess of drug development rests over two well defined pillars, a goodunderstanding of the drug’s clinical pharmacology and the appropriate targetpopulation for whom the clinical use is intended. The label for human prescription drugsrequires a good understanding of the pharmacological effects (pharmacodynamicsor PD) and the mechanism of action of the drug as well as detailed informationof the drug’s Pharmacokinetics (PK): Absorption, distribution, metabolism andexcretion. Theunderstanding of the PK characteristics and PD effects (desired or adverse)will provide educated recommendations about the effective dose, dosing regimen,potential drug-drug interactions and hence contraindications and warnings. Further, the influence of demographic factorson the PK and PD attributes (e.g., age, sex, race, hepatic or renal impairment)need to be well understood to provide the appropriate guidance to patients andcaregivers for patients in specific populations (pediatric, geriatric, organimpairment, pregnancy, etc). In summary, a very extensive portion of the labelcovers clinical pharmacology topics, the following label sections are mainlysupported by clinical pharmacology knowledge collected throughout the course ofdrug development: