The team must understand the clinical context of the disease to be treated and of currently available drug therapy to effectively assess the potential for a new drug. Defining these and determining the questions of primary interest during drug development require significant input from a multidisciplinary team including clinicians and thought leaders in the field. PK questions are generally not primary, though they are an essential piece of the landscape over which the clinical decisions must be made.ĭefinitions of acceptable safety and adequate efficacy are specific to each drug and indication. Though these are specifically kinetic concepts of extent and rate, the clinician is essentially asking questions of safety and efficacy, which when considered quantitatively we call pharmacodynamics (PD). Primary questions of interest to the physician and pharmacist, once a particular drug has been selected for use, are how much and how often should the drug be administered to a particular patient. However, PK considerations in the development and clinical use of drugs generally have a supportive role. Most of the discussion up to this point in our text has been in regard to pharmacokinetics (PK) alone.