ABSTRACT
Once preclinical pharmacology and toxicology is complete, a picture will have developed in lower mammals of the dose of a NAS required to achieve a therapeutic effect, its pharmacokinetics, and how this relates to the maximum nontoxic dose (NOAEL). While they can indicate trends, results from animal studies cannot be accurately relied upon to predict the human condition. The next step is to take the drug into the clinic. The testing of NASs in humans is the “D” part of R&D. As indicated in Chapter 1, this is managed as a series of experiments with widening drug exposure, referred to as Phases I, II, and III.
