ABSTRACT
Several conferences and publications starting in the early 1990s until recently have emphasized the crucial role that pharmacokinetic-pharmacodynamic (PK/PD) modeling and the use of surrogate marker can have in streamlining the drug development process [1-9]. In particular, the advent of pharmacogenomics and biotechnology-derived drug products are thought to accelerate and facilitate the use of these techniques in making the drug development process and regulatory decision-making more rational and efficient [5, 8].
