Pediatric drug development programs for type 2 diabetes: A review

Journal of Clinical Pharmacology
Michael L ChristensenMichael D Reed

Abstract

Considerable progress has been made in pediatric drug development. Despite these gains there remain certain therapeutic areas where a high percentage of drugs approved for use in adults do not gain approval for use in children. Lack of sufficient US Food and Drug Administration (FDA)-approved labeling correlates with diminished therapeutic efficacy and increased risk for adverse drug reactions. Despite the increasing prevalence and important clinical challenge with pediatric type 2 diabetes mellitus (T2DM), only 1 drug (metformin) of the first 4 T2DM drugs to complete testing in children gained FDA approval. This analysis reviews 4 pediatric drug development programs for orally administered antidiabetic agents that have undergone FDA review and discusses factors influencing failure to meet specified end points for approval. Recommendations to guide future study are also provided.

References

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Citations

Jan 23, 2016·Clinical Pharmacokinetics·Puneet GaitondeStephan Schmidt
Sep 12, 2017·Therapeutic Innovation & Regulatory Science·Haihao SunDianne Murphy
Jul 13, 2017·Pediatric Research·Robin A HuffEarl W Seltzer
Dec 27, 2017·Clinical Pharmacology and Therapeutics·Jeffrey S BarrettUNKNOWN IQ consortium - CPLG Pediatric Working Group
Dec 12, 2018·Therapeutic Innovation & Regulatory Science·Klaus Rose, Jane M Grant-Kels
Mar 1, 2018·Therapeutic Innovation & Regulatory Science·Haihao SunDianne Murphy

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