When it comes to dose selection in children it has long been recognised that they are not small adults. They are not a homogenous group. For instance, there is rapidly changing size and weight. In children 3 years old and younger differences exist in the maturity of metabolising enzymes and renal function, along with
Around a third of prescribed drugs are primarily renally eliminated from the body. Unsurprisingly, the influence of renal impairment on drug disposition and ultimately clinical dose is routinely investigated during drug development. The FDA recently issued Draft 2 of its Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data
At the start of October the Food and Drug Administration (FDA) announced the availability of a draft guidance for industry entitled “The Use of Physiologically Based Pharmacokinetic Analyses—Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls.” This guidance provides general recommendations regarding the development, evaluation, and use of physiologically based pharmacokinetic (PBPK)
