HPLC for Pharmaceutical Scientists 2007 (Part 12)

Preformulation is a bridge between discovery and development where development scientists participate in selection and optimization of lead compounds. It is very critical at this stage to evaluate the developability of potential drug candidates in order to select new chemical entities and decrease the number of failures during future drug development. On average, only one out of ten new chemical entities (NCE) entering firstin-human testing reaches registration, approval, and marketing stage. The reasons for failures of development compounds include problems with biopharmaceutical properties, clinical safety, toxicology, efficacy, cost of goods, and marketing (see Figure 12-1) [1, 2]. ...