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[Exploring for Drug Development Seeds for Children Using a Large Claims Data-Survey for Powderization or Decapsulation of Oral Tablets or Capsule Formula in Children].

Kenji Momo, Mami Kobayashi,Tadanori Sasaki

Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan(2023)

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Abstract
Medical big data is accumulated numerous medical related data day by day. These data may have tips for new approach for drug development. Authors tried to find drug-development-needs in children using medical big data analysis with prescription survey. Medical big data were provided from JMDC (Japan Medical Data Centre) Inc. about 3 million participants between January 2005 and June 2017. In these, we identified randomly identified 22787 participants from 466701 participants who are aged ≤11 years. In these participants, 9644 were administered "capsule," "tablet," "orally distegrating tablet," "controlled release tablet/capsule" or "enteric coated tablet" formula drugs. In these, 514 were administered these as powderization or decapsulation. Sixty components administered in 145 participants (28.2%) are not marketed for pediatric formula. On the other hands, 92 components administered in 369 participants (71.8%) are decapsulation or powderization, though pediatric formulas are marketed. These 152 components may have a development seeds for children. In conclusion, prescription survey using medical big data may partially resolve the drug-development-need in pediatrics because by using medical big data will leads low biased data depending each institution.
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Key words
drug development, children, prescription survey, claims data
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