Page 72 - JCTR-11-1

Journal of Clinical and

Translational Research

ORIGINAL ARTICLE
Two simple methods to predict Pediatric Dose

of Antituberculosis Medicines: Application of
Allometry and Salisbury Rule

Iftekhar Mahmood*

Mahmood Clinical Pharmacology Consultancy, Rockville, Maryland, United States of America

Abstract

Background: In drug development, selecting the first-in-human dose is crucial.
Similarly, in pediatric drug development, determining the first-in-pediatric dose is
of paramount importance. Given that the pharmacokinetic, safety, and efficacy of a
product are generally well established in adults, this information can be used to select
an appropriate first-in-pediatric dose for pediatric clinical trials. Methods: Two simple
methods – Salisbury Rule and allometric scaling – were evaluated for predicting
the first-in-pediatric dose to initiate a clinical trial for antituberculosis medicines.
To assess the predictive performance of these methods, the predicted doses were
compared with the observed doses recommended by the World Health Organization
*Corresponding author: (WHO) or the United States Food and Drug Administration (US FDA). Results: This
Iftekhar Mahmood
(Iftekharmahmood@aol.com) study included seven antituberculosis drugs with 62 observations across different
body weight groups. The predictive accuracy of both methods was excellent, with
Citation: Mahmood I. Simple over 80% of the observations falling within a 30% prediction error. Conclusion: The
methods for predicting pediatric
doses of antituberculosis predicted pediatric doses of antituberculosis drugs using the two proposed methods
medicines: Application of allometry reconciled well with the recommended human doses from WHO or the US FDA. The
and the Salisbury rule. J Clin methods are simple and can easily be calculated on a spreadsheet or calculator in
Transl Res. 2025;11(1):66-72.
doi: 10.36922/jctr.24.00070 a short amount of time. Relevance for patients: These two approaches are helpful
for optimizing the selection of appropriate antituberculosis medication dosages in
Received: October 19, 2024
pediatric patients with tuberculosis, ensuring effective treatment, and minimizing
1st revised: December 3, 2024 potential risks.
2nd revised: December 9, 2024
Accepted: January 24, 2025 Keywords: Antituberculosis medicines; Allometry; Body weight; Dose; Pediatric;
Published online: March 4, 2025 Salisbury rule
Copyright: © 2025 Author(s).
This is an open-access article
distributed under the terms of the
Creative Commons AttributionNon- 1. Introduction
Commercial 4.0 International
1-3
(CC BY-NC 4.0), which permits all Tuberculosis (TB) is a prevalent disease in Africa and many South Asian countries.
non-commercial use, distribution, Considering the life-threatening nature of this disease, over the years, many antituberculosis
and reproduction in any medium, medicines have been developed to prevent, manage, or treat TB. On a global scale, the
provided the original work is
properly cited. World Health Organization (WHO) is heavily involved in TB control programs. The
main objective of WHO is to provide guidance for early diagnosis of TB, timely treatment
Publisher’s Note: AccScience
Publishing remains neutral with with appropriate antituberculosis medicines with appropriate therapeutic dosing.
regard to jurisdictional claims in
published maps and institutional TB is caused by a bacterium called Mycobacterium tuberculosis. The main organ of
affiliations bacterial infection in TB is the lungs but other organs such as kidneys, spine and brain can

Volume 11 Issue 1 (2025) 66 doi: 10.36922/jctr.24.00070