Drug Development Preclinical Testing

These metabolites all have half-lives of 24 hours or more, and thus accumulate to a greater extent than the parent drug. Although preclinical testing has demonstrated that these metabolites are pharmacologically active, their beneficial or adverse effects have not been tested beyond one clinical study, which showed that patients in whom higher levels of these metabolites developed had a poorer outcome than those with lower levels ( 316). 

Preclinical drug development also involves animal testing [61]. Data from one rodent species and one nonrodent species are usually collected to determine the absorption, metabolism, and toxicity characteristics of the compound. Both short-term (2 weeks to 3 months) and long-term (up to several years) studies are done. The long-term studies are particularly useful for... 

The costs of drug development increase as a drug progresses through the development pipeline. Preclinical development is the time when chemical compounds are tested in the laboratory to learn as much as possible about how medicines work "in a test tube." These types of experiments can be done with many compounds in a relatively short time and with relatively low cost. This is also the time that animal testing begins to see whether the chemical compounds are safe. These studies help scientists to determine how medicines will be dosed in humans. They are also important to understand whether any toxicity is related to the medicines. Toxicological tests are time... 

Sun D, Lawrence XY, Hussain MA, Wall DA, Smith RL, Amidon GL (2004) In vitro testing of drug absorption for drug developability assessment Forming an interface between in vitro preclinical data and clinical outcome. Curr. Opin. Drug Discov. Dev. 7 75-85. 

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. 

Pessina, A., Malerba, 1. and Gribaldo, L. (2005) Hematotoxicity testing by cell clonogenic assay in drug development and preclinical trials. Current Pharmaceutical Design, 11, 1055-1065. 

The clinical drug development process required by the US FDA, arguably the most stringent in the world, starts with the investigational new drug (IND) application prior to human testing. It reveals information about all known compounds to be used and includes the description of the clinical research plan for the product as well as the protocol for phase I studies. Preclinical study results also need to be revealed. 

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