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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Challenges in Pediatric drug development Conference Speakers
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