Drug development hurdles

To help investigators overcome these hurdles, several case studies will be presented in this chapter from a pharmacokinetic perspective. Some pharmacokinetic strategies in the drug development will also be discussed to mitigate or overcome the inherent caveats of water-insoluble drugs. 

The failure of drugs at later stages of development, particularly in clinical trials, is very expensive for drug developers and, more importantly, patients. To better understand the key reasons for these failures, Lipinski et al,14 undertook an analysis of the properties of compounds that entered Phase II human clinical trials. They selected a subset of 2245 compounds from the World Drug Index (WDI) database of over 50000 compounds after eliminating the majority of compounds for various well-reasoned criteria. This subset of compounds had assigned trade names and, as a result, were assumed to have entered Phase II oral efficacy studies and be expected to have superior physico-chemical properties since they would have passed most of the other earlier clinical trial hurdles. 

Notes Best practices refers to drug development organizations with established good records of bringing drugs to market. In particular, best practices include a high hurdle for a drug candidate to enter development or Phase I. 

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