ABSTRACT
The World Health Organization (WHO) Scientific Group has defined a drug as “any substance or product that is used or intended to be used to modify or explore physiological systems or pathological states for the benefit of the recipient” [154]. The drug discovery process covers a wide range of therapeutic areas and treatment regimens and is a risky, multifaceted, expensive undertaking. The goal is to develop a new product with therapeutic benefits (efficacy) and few side effects (toxicity) [4]. The drug development process for a new chemical entity (NCE) starts at the chemist’s bench with its isolation, moves through efficacy pharmacology testing using various
in
vivo
and
in vitro
models, then proceeds through an abbreviated toxicology profile, including pharmacologic profiling (the determination of pharmacologic effects other than the desired therapeutic effect), based on the proposed clinical plan for the first human dose (FHD).
