Preclinical drug development pharmacokinetic testing

The paradigm in drug development is sequentially divided into several phases starting with preclinical assessment. After selection of a drug candidate based on preclinical studies, clinical Phase 1 studies are initiated to characterize the safety, tolerability, biomarker, and pharmacokinetic profiles of the candidate, typically in healthy subjects. Phase 2 studies test the drug efficacy hypothesis in patients and explore dose range, and Phase 3 studies aim to demonstrate efficacy in the intended patient population in a statistically robust manner. 

Drug Development Tests are performed on the lead compounds in test tubes (laboratory, in vitro) and on animals (in vivo) to check how they affect the biological systems. The tests, often called preclinical research activities, include toxicology, pharmacodynamics and pharmacokinetics, as well as optimization of drug delivery systems. Many iterations are carried out, and the leading compounds are modified and synthesized to improve their interactions with the targets, or to reduce the toxicity or improve pharmacokinetics performance. At the end of this process, an optimized compound is found and this becomes a potential drug ready for clinical trial... 

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