Page 42 - ITPS-7-4

INNOSC Theranostics and
Pharmacological Sciences Pediatric drug regulations in India

9. Rocchi F, Tomasi P. The development of medicines for Boat TF, editors. Safe and Effective Medicines for Children:
children. Part of a series on pediatric pharmacology, guest Pediatric Studies conducted Under the Best Pharmaceuticals
edited by Gianvincenzo Zuccotti, Emilio Clementi, and for Children Act and the Pediatric Research Equity Act.
Massimo Molteni. Pharmacol Res. 2011;64(3):169-175. Washington, DC: National Academies Press; 2012.
doi: 10.1016/j.phrs.2011.01.016 20. Zhang L, Li Y, Liu Y, et al. Pediatric off-label drug use in
China: Risk factors and management strategies. J Evid Based
10. Standing JF, Tuleu C. Paediatric formulations--Getting to
the heart of the problem. Int J Pharm. 2005;300(1-2):56-66. Med. 2013;6(1):4-18.
doi: 10.1111/jebm.12017
doi: 10.1016/j.ijpharm.2005.05.006
21. Janković S, Ilić D. Improving clinical drug development
11. Verrue C, Mehuys E, Boussery K, Remon JP, Petrovic M.
Tablet-splitting: A common yet not so innocent practice. regulatory procedures for anticonvulsants. Racion Ter.
J Adv Nurs. 2011;67(1):26-32. 2015;7(2):23-28.
doi: 10.5937/racter7-8767
doi: 10.1111/j.1365-2648.2010.05477.x
22. Ivanovska V, Rademaker CM, van Dijk L, Mantel-Teeuwisse
12. Skwierczynski C, Conroy S. How long does it take to
administer oral medicines to children? Paediatr Perinat AK. Pediatric drug formulations: A review of challenges and
Drug Ther. 2008;8(4):145-149. progress. Pediatrics. 2014;134(2):361-372.
doi: 10.1542/peds.2013-3225
doi: 10.1185/146300908X254206
13. Conroy S, Sweis D, Planner C, et al. Interventions to reduce 23. Ajay S, Vikaas B, Manjusha C. A comprehensive study on
dosing errors in children: A systematic review of the regulation on clinical trials of pediatrics in US, EU and
literature. Drug Saf. 2007;30(12):1111-1125. India. Pharma Innov J. 2016;5(10):16-22.
doi: 10.2165/00002018-200730120-00004 24. Venkatesh MP. Regulation for paediatric drug development
in India: Need of the hour. J Clin Stud. 2014;6(1):14-17.
14. Fernandez E, Perez R, Hernandez A, Tejada P, Arteta M,
Ramos JT. Factors and mechanisms for pharmacokinetic 25. Srivastava A, Bourgeois FT. Evaluation of publication of
differences between pediatric population and adults. pediatric drug trials. JAMA Netw Open. 2021;4(4):e215829.
Pharmaceutics. 2011;3(1):53-72. doi: 10.1001/jamanetworkopen.2021.5829
doi: 10.3390/pharmaceutics3010053 26. Vieira I, Sousa JJ, Vitorino C. Paediatric
15. Quinzler R, Gasse C, Schneider A, Kaufmann-Kolle P, medicines - Regulatory drivers, restraints, opportunities and
Szecsenyi J, Haefeli WE. The frequency of inappropriate challenges. J Pharm Sci. 2021;110(4):1545-1556.
tablet splitting in primary care. Eur J Clin Pharmacol. doi: 10.1016/j.xphs.2020.12.036
2006;62(12):1065-1073.
27. Shirkey H. Therapeutic orphans. Pediatrics. 1999;104(3):583-584.
doi: 10.1007/s00228-006-0202-3
28. Ballentine C. Sulfanilamide Disaster FDA Consumer
16. Sri Ranganathan S. Medicines for children: Rationale and Magazine June 1981 Issue. Available from: https://www.fda.
recent advances. J Postgrad Inst Med. 2017;4(1):48. gov [Last accessed on 2024 Apr 19].
doi: 10.4038/jpgim.8155 29. Ward RM, Benjamin DK Jr., Davis JM, et al. The Need for
17. Verscheijden LFM, Koenderink JB, Johnson TN, de Wildt SN, pediatric drug development. J Pediatr. 2018;192:13-21.
Russel FGM. Physiologically-based pharmacokinetic models doi: 10.1016/j.jpeds.2017.08.011
for children: Starting to reach maturation? Pharmacol Ther. 30. DeDonato EA, Spiller HA, Casavant MJ, Chounthirath T,
2020;211:107541.
Hodges NL, Smith GA. Non-health care facility
doi: 10.1016/j.pharmthera.2020.107541 anticonvulsant medication errors in the United States. Hum
18. Wu F, Mousa Y, Raines K, et al. Regulatory utility of Exp Toxicol. 2018;37(6):561-570.
physiologically-based pharmacokinetic modeling to support doi: 10.1177/0960327117721962
alternative bioequivalence approaches and risk assessment:
A workshop summary report. CPT Pharmacometrics Syst 31. Egger J, Brett EM. Effects of sodium valproate in 100
Pharmacol. 2023;12(5):585-597. children with special reference to weight. Br Med J (Clin Res
Ed). 1981;283(6291):577-581.
doi: 10.1002/psp4.12907
doi: 10.1136/bmj.283.6291.577
19. Committee on Pediatric Studies Conducted under the Best
Pharmaceuticals for Children Act (BPCA) and the Pediatric 32. Degnan LA. Reye’s syndrome: A rare but serious pediatric
Research Equality Act (PREA), and Institute of Medicine condition. U.S. Pharm. 2012;37(3):HS6-HS8.
(U.S.), Board on Health Sciences Policy. In: Field MJ, 33. Dahl R. Systemic side effects of inhaled corticosteroids in

Volume 7 Issue 4 (2024) 17 doi: 10.36922/itps.3831