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Original Articles

A Study of Safety Factors for Risk Assessment of Drugs Used for Treatment of Attention Deficiency Hyperactivity Disorder in Sensitive Populations

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Pages 823-840 | Published online: 03 Jun 2010
 

Abstract

The aim of this study was to search the literature through the library and Internet resources from pharmaceutical companies and associations to obtain pharmacoki-netic and pharmacodynamic data for six of the most used drugs for treatment of Attention Deficiency Hyperactivity Disorder (ADHD). The drugs included meth-ylphenidate, pemoline, haloperidol, bupropion, imipramine, and desipramine. The data collected allowed the evaluation of the 10X uncertainty factor, which was related to healthy adults and sensitive populations (children, elderly and health affected). Once the extensive database review was completed, the data were used to calculate a composite factor (kinetics x dynamics) for each drug. Ten of the 12 data-derived composite factors were less than 10. Therefore, incorporation of human kinetic and dynamic data into risk assessment can help to reduce the uncertainties associated with sensitive subgroups.

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