Demonstrating evidence of acceptability: the "catch-22" of pediatric formulation development

Clin Pharmacol Ther. 2013 Nov;94(5):582-4. doi: 10.1038/clpt.2013.154. Epub 2013 Jul 26.

Abstract

Both researchers and practitioners have reached an influential period in the new era of developing pediatric medicines. Evolving regulatory reforms and guidance continue to serve as platforms steering research and development while distinctive opportunities and challenges in the field emerge. An advancing research need involves gaining a better understanding of end-user requirements and acceptability of formulations. This review considers solid oral forms to demonstrate the importance of such research to stakeholders in policy and practice.

Publication types

  • Review

MeSH terms

  • Administration, Oral
  • Age Factors
  • Capsules / administration & dosage
  • Capsules / adverse effects
  • Capsules / standards
  • Capsules / therapeutic use
  • Child
  • Dosage Forms* / standards
  • Drug Evaluation* / methods
  • Drug Evaluation* / standards
  • Humans
  • Tablets / administration & dosage
  • Tablets / adverse effects
  • Tablets / standards
  • Tablets / therapeutic use

Substances

  • Capsules
  • Dosage Forms
  • Tablets