Figure 2.

Preclinical flow diagram. The parallel and inter-related activities contributing to preclinical development are summarized with color coding to denote related components: manufacturing (red), analytical (grey), documentation (orange), safety (blue), clinical (green). API, active pharmaceutical ingredient; CMC, chemistry, manufacturing, and controls; FDA, US Food and Drug Administration; GLP, good laboratory practice; GMP, good manufacturing practice; ICF, informed consent form; IND, Investigational New Drug; PK, pharmacokinetics.

Steinmetz and Spack BMC Neurology 2009 9(Suppl 1):S2   doi:10.1186/1471-2377-9-S1-S2