Metabolites in safety testing

From the perspective of the pharmaceutical industry, the attention given to metabolites started to increase when the Pharmaceutical Research and Manufacturers of America (PhRMA) commissioned a review of the role of metabolites in dmg induced toxicity. This group, called the metabolites in safety testing (MIST) committee, partnered with the U.S. Food and Drug Administration, convened several... 

TABLE 1.6. Recent Publications/Events on Metabolite in Safety Testing... 

PhRMA—Commissioned a survey of current practices in dealing with metabolites in safety testing... 

Several workshops held to discuss metabolites in safety testing approaches across pharmaceutical industry and the expectations from FDA. 

Mentions that a formal guidance on the issue of drug metabolites in safety testing is warranted. 

Smith, D. A. and Obach, R. S. (2005). Seeing through the mist abundance versus percentage. Commentary on metabolites in safety testing. Drug. Metab. Dispos. 33(10) 1409-1417. 

Baillie TA, Cayen MN, Fouda H et al. (2002) Drug metabolites in safety testing. Toxicol Appl Pharmacol 182 188-196... 

FIGURE 5.9 A proposed work flow for addressing metabolite in safety testing guidance and detecting and characterizing human metabolites in SAD and MAD studies. 

Smith, D.A. and Obach, R.S., Metabolites in safety testing (MIST) Considerations of mechanisms of toxicity with dose, abundance, and duration of treatment, Chem. Res. Toxicol., 22(2), 267, 2009. 

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