Scholarlink

Drug development studies in pediatric patients have evolved in about the same time frame as the medical specialty of pediatric dermatology. While the efficacy trial design has a number of elements that have to be carefully planned, such as endpoints and enrichment of the study population as well as inclusion of a placebo, drug dosing and drug safety are the most critical factors to be addressed in pediatric dermatology drug development studies. Safety studies include maximal use trials and may include growth studies. Exposure-response analysis and modeling and simulation are now routine parts of a pediatric drug development trial. These advanced clinical pharmacology techniques must be applied to future drug development studies in pediatric dermatology.

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Clinical Pharmacology of Dermatology Products in Pediatric Drug Development

  • 章节

  • 发表日期：

    2025年

查看全文
  • Gilbert J. Burckart,
  • Elimika Pfuma Fletcher,
  • Chinmay Shukla

摘要

Drug development studies in pediatric patients have evolved in about the same time frame as the medical specialty of pediatric dermatology. While the efficacy trial design has a number of elements that have to be carefully planned, such as endpoints and enrichment of the study population as well as inclusion of a placebo, drug dosing and drug safety are the most critical factors to be addressed in pediatric dermatology drug development studies. Safety studies include maximal use trials and may include growth studies. Exposure-response analysis and modeling and simulation are now routine parts of a pediatric drug development trial. These advanced clinical pharmacology techniques must be applied to future drug development studies in pediatric dermatology.