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Current situation of pediatric clinical trials in China: focus on trials for drug marketing application and administrative approval.

Lin SongYuntao JiaSujuan RanBin LiJin XuBennian HuoNange YinMaolin AiYao Liu
Published in: BMC pediatrics (2022)
The number of pediatric clinical trials in China has increased these years. To further promote pediatric clinical trials and motivate pediatric appropriate drug marketing application and administrative approval, conducting large pediatric clinical trials, further development of dosage forms suitable for children with special attention to neonates and prematurity, and improving uneven geographical distribution of sponsors and researchers are the current challenges.
Keyphrases
  • clinical trial
  • phase ii
  • preterm infants
  • low birth weight
  • open label
  • adverse drug
  • drug induced