Drug development begins when a lead compound has been identified in a drug discovery process; it involves multiple stages that are required to bring a new pharmaceutical drug to market.
The earliest stages of drug development involve preclinical studies to determine a candidate’s safety profile. However, the drug development process includes product characterization, formulation, delivery, packaging development, pharmacokinetics, pharmacodynamics, ADME, preclinical toxicology and finally clinical trials.
Clinical trials are made up of different phases, phases I – IV, with each phase recruiting more participants. Phase I looks to assess the safety of a drug or device. Phase II aims to test the efficacy and phase III studies involve randomized blind testing on large sample groups. Phase IV involves post marketing surveillance.
Bioanalytical studies and bioanalytical method development support most stages in the drug development process. This includes the appropriate characterization of molecules, assay development and optimal method development. Bioanalysis supports pre-clinical testing and clinical trials as well as quality assurance and quality control for the entire development process.