Bioavailability testing clinical study design

In 1975 an EU Directive (75/318/EEC) required each member state to ensure the submission of safety and efficacy for marketing authorisation. Good laboratory practice (GLP) became the principle of non-clinical testing on pharmaceutical products and the requirement of a GCP standard in conducting clinical trials. It stated that all phases of clinical investigation, including bioavailability and bioequivalence studies shall be designed, implemented and reported in accordance of GCP (75/318/EEC, B.1.1). 

The last step of the drug discovery process involves the testing of lead compounds to address issues such as efficacy, bioavailability, and safety. Testing may include in vitro assays but ultimately would require a suitable disease model and studies in animals. Many compounds may need to be designed and synthesized to identify the one compound with all the desired properties. Such a compound can be advanced to preclinical studies and eventually to the clinic. 

---