Page 44 - ITPS-7-4

INNOSC Theranostics and
Pharmacological Sciences Pediatric drug regulations in India

Pediatr. 2022;22(1):442. Pediatric medicine development: An overview and
comparison of regulatory processes in the European Union
doi: 10.1186/s12887-022-03457-1
and United States. Ther Innov Regul Sci. 2017;51(3):360-371.
56. Ueyama E, Kaneko M, Narukawa M. Analysis of
pediatric drug approval lag in Japan. Ther Innov Regul Sci. doi: 10.1177/2168479017696265
2021;55(2):336-345. 64. Spadoni C. Pediatric drug development: Challenges and
doi: 10.1007/s43441-020-00218-z opportunities. Curr Ther Res Clin Exp. 2019;90:119-122.
57. Kusuoka H, Yamane T. Discussions on Evaluation of Medical doi: 10.1016/j.curtheres.2018.12.001
Devices in Pediatric Use; 2016, Available from: https://www. 65. Batchelor HK, Marriott JF. Paediatric pharmacokinetics: Key
pmda.go.jp/files [Last accessed on 2024 Apr 04]. considerations. Br J Clin Pharmacol. 2015;79(3):395-404.
58. Konishi A, Isobe S, Sato D. New regulatory framework for doi: 10.1111/bcp.12267
medical devices in Japan: Current regulatory considerations
regarding clinical studies. J Vasc Interv Radiol. 66. O’Hara K. Paediatric pharmacokinetics and drug doses.
2018;29(5):657-660. Aust Prescr. 2016;39(6):208-210.
doi: 10.1016/j.jvir.2017.12.022 doi: 10.18773/austprescr.2016.071
59. Takahashi S, Ibrahim N, Yasukochi S, et al. Partnership 67. Klassen TP, Hartling L, Craig JC, Offringa M. Children are
between Japan and the United States for early development not just small adults: The urgent need for high-quality trial
of pediatric medical devices - harmonization by doing for evidence in children. PLoS Med. 2008;5(8):1180-1182.
children. Circ J. 2020;84(5):786-791. doi: 10.1371/journal.pmed.0050172
doi: 10.1253/circj.CJ-19-1092 68. Christiansen H, De Bruin ML, Hallgreen CE. Mandatory
60. Takahashi S, Iwasaki K, Shirato H, Ho M, Umezu M. requirements for pediatric drug development in the EU
Comparison of supportive regulatory measures for pediatric and the US for novel drugs-A comparative study. Front Med
medical device development in Japan and the United States. (Lausanne). 2022;9:1009432.
J Artif Organs. 2021;24(1):90-101. doi: 10.3389/fmed.2022.1009432
doi: 10.1007/s10047-020-01216-6 69. Caldwell PH, Murphy SB, Butow PN, Craig JC. Clinical
61. Saitou H, Nakatani D, Myoui A, Kubota T, Ozono K. trials in children. Lancet. 2004;364(9436):803-811.
Pediatric drug development in Japan: Current issues and doi: 10.1016/S0140-6736(04)16942-0
perspectives. Clin Pediatr Endocrinol. 2020;29(1):1-7.
70. Narayanan. Executive Members. Available from: https://
doi: 10.1297/cpe.29.1 www.iapdrugfomulary.com [Last accessed on 2024 May 01].
62. Rose K. The challenges of pediatric drug development. Curr 71. Wu W, Tang Z, Chen J, Gao Y. Pediatric drug development
Ther Res Clin Exp. 2019;90:128-134.
in China: Reforms and challenges. Pharmacol Res.
doi: 10.1016/j.curtheres.2019.01.007 2019;148:104412.
63. Penkov D, Tomasi P, Eichler I, Murphy D, Yao LP, Temeck J. doi: 10.1016/j.phrs.2019.104412

Volume 7 Issue 4 (2024) 19 doi: 10.36922/itps.3831