Substantial differences can exist in the absorption, distribution, metabolism, and excretion (ADME) of orally and/or systemically administered medicines depending on the age of patients or animals, leading to potential differences in drug efficacy and toxicity. These differences are usually most prominent in the neonatal period and early infancy. Likewise, maturational changes in the physiology of the gastrointestinal tract (GIT), liver, and renal systems can impact the ADME parameters and result in rapidly changing systemic exposures with progressing age.
The HESI Developmental and Reproductive Toxicology (DART) Committee launched a multisector collaborative research effort to increase the knowledge base in the nonclinical neonatal space to better inform decisions made in the clinic. This program brings together an international multidisciplinary team from academia, industry, and government to address the gaps in neonatal drug development through distinct, but interconnected, projects (Davis-Bruno et al., 2016).
Full text online: http://dmd.aspetjournals.org/content/47/3/295