Fig. 1.

Study designs and selection process. a Selection algorithm for agile designs. b Customary and alternative designs evaluated (top row of designs have fixed dose increments while the dose increments in the bottom row change during the trial. Details are provided for each design: top number of total treatments N; tables fold increase is indicated with numbers of subjects in parentheses (drug/placebo), last doses administered prior PK review are indicated by *. Dose of interest is highlighted; bottom number of subjects per arm, fold increments and number of treatments per subject.)