This paper "Relevance of Preclinical Studies" is a wonderful example of preclinical research. The preclinical stage of drug development precedes clinical trials. There are several parameters that need evaluation before the drug is tested on humans and animals. Some of these parameters are such as pharmacokinetics, drug safety, pharmacodynamics, and toxicological data. The preclinical studies help predict the toxic effects, efficacy, dose dependence, safety and further extrapolate the potential human outcome (Kumar & Longstreth, 2011). 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.
ReferencesKumar, M., & Longstreth, J. (2011, December 1). Risks and Benefits of Conducting Preclinical Studies in the Global Setting. Retrieved May 24, 2015, from https://www.amarexcro.com/articles/docs/RAPS_Focus_Preclinical_Global_Dec2011.pdf