Page 77 - JCTR-11-1

Journal of Clinical and
Translational Research Pediatric dosing of antituberculosis medicines

Availability of data doi: 10.1128/AAC.01701-16

References for the data used in this study are provided 10. Bekker A, Schaaf HS, Draper HR, et al. Pharmacokinetics
within the article. of rifampin, isoniazid, pyrazinamide, and ethambutol in
infants dosed according to revised WHO-recommended
References treatment guidelines. Antimicrob Agents Chemother.
2016;60:2171-2179.
1. WHO. Operational Handbook on Tuberculosis Module 5:
Management of Tuberculosis in Children and Adolescents; doi: 10.1128/AAC.02600-15
2022. Available from: https://www.who.int/publications/i/ 11. Justine M, Yeconia A, Nicodemu I, et al. Pharmacokinetics
item/9789240046832 [Last accessed on 2024 Aug 19]. of first-line drugs among children with tuberculosis in rural
2. World Health Organization. WHO Operational Handbook Tanzania. J Pediatr Infect Dis Soc. 2020;9(1):14-20.
on Tuberculosis. Module 4: Treatment: Drug-susceptible doi: 10.1093/jpids/piy106
Tuberculosis Treatment; 2022. Available from: https://apps.
who.int/iris/handle/10665/354548 [Last accessed on 2024 12. Mahmood I. Dosing in children: A critical review of
Aug 19]. the pharmacokinetic allometric scaling and modelling
approaches in paediatric drug development and clinical
3. World Health Organization. Global Tuberculosis Report; settings. Clin Pharmacokinet. 2014;53:327-346.
2020. Available from: https://apps.who.int/iris/bitstream/
handle/10665/336069/9789240013131-eng.pdf [Last doi: 10.1007/s40262-014-0134-5
accessed on 2024 Aug 19]. 13. Green DJ, Zineh I, Burckart GJ. Pediatric drug development:
4. Drobac PC, Shin SS, Huamani P, et al. Risk factors Outlook for science-based innovation. Clin Pharmacol Ther.
for in-hospital mortality among children with 2018;103:376-378.
tuberculosis: The 25-year experience in Peru. Pediatrics. doi: 10.1002/cpt.1001
2012;130(2):e373-e379.
14. Abernethy DR, Burckart GJ. Pediatric dose selection. Clin
doi: 10.1542/peds.2011-3048 Pharmacol Ther. 2010;87:270-271.
5. World Health Organization. Implementing the End TB doi: 10.1038/clpt.2009.292
Strategy: The Essentials; 2022. Available from: https://www.
who.int/publications/i/item/9789240065093 [Last accessed 15. Mahmood I. Dose selection in children. In: Pharmacokinetic
on 2024 Aug 19]. Allometric Scaling in Pediatric Drug Development. Rockville:
Pine House Publishers; 2013. p. 151-60.
6. World Health Organization. Technical Report on the
Pharmacokinetics and Pharmacodynamics (PK/PD) 16. Rowland M, Peck C, Tucker G. Physiologically-based
of Medicines Used in the Treatment of Drug-resistant pharmacokinetics in drug development and regulatory
Tuberculosis. World Health Organization; 2018. Available science. Annu Rev Pharmacol Toxicol. 2011;51:45-73.
from: https://apps.who.int/iris/handle/10665/260440 [Last doi: 10.1146/annurev-pharmtox-010510-100540
accessed on 2024 Aug 20].
17. Zhou W, Johnson TN, Xu H, et al. Predictive performance
7. European Medicines Agency. Joint Evaluation of Regulation of physiologically based pharmacokinetic and population
(EC) No 1901/2006 of the European Parliament and of the pharmacokinetic modeling of renally cleared drugs in children.
Council of 12 December 2006 on Medicinal Products for CPT Pharmacometrics Syst Pharmacol. 2016;5:475-483.
Paediatric Use and Regulation (EC) No 141/2000 of the
European Parliament and of the Council of 16 December doi: 10.1002/psp4.12101
1999 on Orphan Medicinal Products. Available from: 18. Edginton AN, Theil FP, Schmitt W, Willmann S. Whole
https://health.ec.europa.eu/system/files/2020-08/orphan- body physiologically-based pharmacokinetic models: Their
regulation_eval_swd_2020-163_part-1_0.pdf [Last accessed use in clinical drug development. Expert Opin Drug Metab
on 2024 Aug 20]. Toxicol. 2008;4:1143-1152.
8. US Food and Drug Administration. General Clinical doi: 10.1517/17425255.4.9.1143
Pharmacology Considerations for Pediatric Studies for 19. Mahmood I. Prediction of drug clearance in premature
Medicines and Biological Products. Draft Guidance. and mature neonates, infants, and children ≤2 years of age:
Available from: https://www.fda.gov/downloads/medicines/ A comparison of the predictive performance of 4 allometric
guidancecomplianceregulatoryinformation/guidances/ models. J Clin Pharmacol. 2015;56:733-739.
ucm425885.pdf [Last accessed on 2024 Aug 20].
doi: 10.1002/jcph.652
9. Antwi S, Yang H, Enimil A, et al. Pharmacokinetics of the
first-line antituberculosis drugs in Ghanaian children with 20. Cao Y, Balthasar JP, Jusko WJ. Second-generation minimal
tuberculosis with or without HIV coinfection. Antimicrob physiologically-based pharmacokinetic model for
Agents Chemother. 2017;61:e01701-e01716. monoclonal antibodies. J Pharmacokinet Pharmacodyn.

Volume 11 Issue 1 (2025) 71 doi: 10.36922/jctr.24.00070