Optimal dose individualization has become more important in improving clinical efficacy and safety, given the variability in drug response, e.g., due to concurrent illnesses or co-medications. Therefore, the role of optimal dose finding in early clinical drug development so as to maximize successful clinical use is emphasized. The continued use of biomarkers - based on the (known) pharmacology of the drug and/or biology of the underlying disease - along with exposure-response evaluation throughout all phases of drug development can quantitatively integrate clinical pharmacology knowledge,...