Relevance of Preclinical Studies - Essay Example

After a company or research organization selects a compound of interest, preclinical studies are initiated both in vitro and in vivo. The researcher's design study materials to provide evidence that a drug is neither teratogenic nor mutagenic. The safety deduced from the preclinical studies is crucial in convincing all parties involved that the drug can proceed for testing in human studies. The studies also guide researchers in planning phase one of the clinical trials. Preclinical studies, for example, with humans determine the approximate dosing of a drug to be assessed in subsequent clinical trials. They identify criteria for examining the safety, including symptoms and signs that require close monitoring during the initial clinical trials. Although the studies are not accurate predictors of what exactly happens, they help narrow margins or errors (Kumar & Longstreth, 2011).

The preclinical studies generate pharmacologic profiles of drugs that are beneficial for the drugs’ future use. Researchers can, for example, use the specifications detailed in the studies to assess the purity, stability, and chemical quality of the drug during subsequent manufacturing processes. The preclinical studies based on their nature are vital in the development of drugs for all diseases and, in particular, the rare ones.