Abstract

In the pharmaceutical industry, identification of a development drug candidate (preclinical lead profile, PLP, or early candidate notification, ECN), filing of investigational new drug application (IND), and new drug application (NDA) are important milestones before the launch of a new drug. The IND and the NDA are the events where the industry interacts with the Food and Drug Administration (FDA) prior to launching. Various governmental departments play specific roles in furthering drug development programs. The medicinal or discovery chemists identify the new drug candidates to treat or prevent a particular medical indication, whereas the process chemists are responsible for devising a synthesis and supplying the active pharmaceutical ingredient (API) or bulk drug substance (BDS) in multigram quantities for various studies needed to file the IND and support other drug development programs. On approval of the IND, the compound can be administered to humans for the first time as part of the phase-I clinical studies, also known as first-in-man (FIM) trials. Studies that are reported in an IND include synthesis, animal toxicology, pharmaceutics and formulation, drug substance and drug product stability and safety, and metabolic and pharmacokinetics.