ABSTRACT
Current trends within the pharmaceutical industry and within the offices of some regulatory authorities [in particular the U.S. Food and Drug Administration (FDA)] suggest a promising future for modeling and simulation (M&S)—incorporating pharmacokinetic and pharmacodynamic (PK/PD) modeling and clinical trial simulation (CTS) (1-5). The methodology has the potential to become an indispensable tool in pre-/nonclinical development, in early and late clinical development, and in the postmarketing phases. As such it will provide the scientific evidence for key decision points during the development of clinical entities.
