作者: Amer Al‐Khouja , Kyunghun Park , Daijha J.C. Anderson , Caitlyn Young , Jian Wang
DOI: 10.1002/JCPH.1676
关键词: Drug toxicity 、 Clinical evidence 、 Clearance 、 Drug 、 Clinical study 、 Special populations 、 Intensive care medicine 、 Medicine 、 Dosing 、 Drug development
摘要: A treatment gap exists for pediatric patients with renal impairment. Alterations in clearance and metabolism of drugs render standard dosage regimens inappropriate may lead to drug toxicity, but these studies are not routinely conducted during development. The objective this study was examine the clinical evidence behind current impairment recommendations a dosing handbook. sources comparisons included handbook (Lexicomp), U.S. Food Drug Administration-approved manufacturer's labels, published literature. One hundred twenty-six Lexicomp had recommendations. Only 14% (18 126) referenced study, 15% labels (19 described specific renally impaired patients. Forty-two products information on dosing, 19 (45%) were case studies. When Lexicomp, followed adult label. Clinical does exist most widely used handbook, from label currently primary source information.