ABSTRACT
The process of discovery and development of safe and effective new medicines is long, difficult, and expensive. Drug development focuses on new dosage forms, routes of administration, and delivery devices for existing drugs. Drug development studies include preclinical studies, whereby a compound is thoroughly characterized for physicochemical characteristics and is tested in animal models for toxicity and activity. New drug discovery and development process can be divided into distinct sequential phases that evaluate and develop the drug-like characteristics of a potential new compound being considered a drug candidate. The progression of new drug candidates through various stages of this sequential process depends on successful demonstration of drug-like characteristics in each of these phases. Pharmaceutical scientists work on developing suitable dosage forms for drug administration at different stages of drug development. These might include, for example, a parenteral solution formulation during efficacy and toxicology studies in vitro and in animal models.
