RT Book, Section A1 Lau, S.W. Johnny A1 Cheung, Lily K. A1 Chow, Diana Shu-Lian A2 Shargel, Leon A2 Yu, Andrew B.C. SR Print(0) ID 1117902332 T1 Application of Pharmaco­kinetics to Specific Populations: Geriatric, Obese, and Pediatric Patients T2 Applied Biopharmaceutics & Pharmacokinetics, 7e YR 2016 FD 2016 PB McGraw-Hill Education PP New York, NY SN 9780071830935 LK accesspharmacy.mhmedical.com/content.aspx?aid=1117902332 RD 2024/04/19 AB The biggest issue in PK/PD and drug therapy is variability in response.* Variability factors that affect pharmacokinetics and pharmacodynamics influence clinical trials and dose regimen designs. Early in drug development, the term “pharmacokinetics in disease states” was used to describe disease factors that affect PK. This term is concise but proved inadequate in the regulatory and clinical environment. The term “population” pharmacokinetics was then used to emphasize that the PD response can be quite different dependent on the demographic of the subjects. In the clinical trial and labeling environment, the term “specific populations” may be used to convey important specific medical conditions such as cancer or other pathophysiologic conditions that greatly influence the patient’s outcome. The terms “specific” and “special” have been used in different occasions referring to different subject populations or patient conditions.