Impact of Quantitative Pharmacology on Drug Development

The success of drug development rests over two well defined pillars, a good understanding of the drug’s clinical pharmacology and the appropriate target population for whom the clinical use is intended. The label for human prescription drugs requires a good understanding of the pharmacological effects (pharmacodynamics or PD) and the mechanism of action of the drug as well as detailed information of the drug’s Pharmacokinetics (PK): Absorption, distribution, metabolism and excretion (FDA, 2014). The understanding 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 factors on 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 and caregivers for patients in specific populations (pediatric, geriatric, organ impairment, pregnancy, etc). In summary, a very extensive portion of the label covers clinical pharmacology topics, the following label sections are mainly supported by clinical pharmacology knowledge collected throughout the course of drug development: