FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

ICH Guideline Suggests ‘Weight of Evidence’ Analysis Before Nonclinical Pediatric Trials

Jan. 29, 2019
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Sponsors should consider whether they need to conduct nonclinical safety experiments on drugs before moving on to pediatric trials, according to an ICH draft guideline the FDA released for comment last week.

The guideline, S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines, recommends taking an integrated, weight-of-evidence approach to nonclinical trials — considering pharmacology, pharmacokinetic, in vitro, in vivo animal and clinical safety data — to make sure that no single factor is considered in isolation.

Generally, nonclinical experiments won’t be necessary if “existing clinical data are considered sufficient to support pediatric use and/or if identified safety concerns can be clinical managed,” the ICH document states.

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