Challenges in Pediatric drug development

Pediatric drug development is a challenge for over the past half a century. There are quite a few childhood diseases which have significant occurrence rates in pediatric subjects but  for which there are no approved drugs. Reports say that as a result of low prioritization of pediatric drug development globally about 75% of drugs do not carry regulatory approval for use in infants or children; ~66% of medications used in children in the US are used off label, 50% in Europe and in Japan it is less than 20%. Most medications in these regions donot contain package inserts have adequate information for treating infants or children. This session will address all such issues including R&D, F&D and regulatory framework with research scientists from different pharmaceutical industries and also drug discovery researchers.

  • Regulatory framework
  • Challenges in developing and prescribing drugs for children
  • Models for enhancing pediatric drug development
  • Challenges and opportunities for the future
  • Differences in Drug response
  • Differences in Toxicity profiles
  • Differences in Drug metabolism
  • Route of administration
  • Dosage form suitability
  • Patient compliance

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