Toxicology pediatric studies

Blood matrices are a field of great development concern regarding sample collection and handling. Within this field, there is growing interest in the analysis of dried blood spots (DBS) and dried matrix spots (DMS). The use of such supports presents numerous advantages over traditional wet plasma sampling techniques they are less invasive and use less blood, which enables juvenile toxicology and pediatric studies... 

Daum F, Cohen MI, McNamara H, et al. 1976. Experimental toxicologic studies on a phenol detergent associated with neonatal hyperbilirubinemia. J Pediatr 89 853-854. 

In studies conducted on diseases mainly affecting pediatric patients, the development will be entirely in pediatric patients. However, in addition to the appropriate usual toxicology and neonate animal toxicology, the first-in-humans studies for toxicity and safety are usually done in healthy adult volunteers. Clearly, however, drugs such as the surfactants would yield no useful data from adult testing. For these unique pediatric situations, new measurements and end points may need to be developed and validated. Frequently, the FDA will involve an advisory panel to help determine what these might be. 

Lester BM, ElSohly M, Wright LL et al (2001) The maternal lifestyle study drug use by meconium toxicology and maternal self-report. Pediatrics 107 309-317... 

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