2021
DOI: 10.1002/jcph.1853
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Methods Used for Pediatric Dose Selection in Drug Development Programs Submitted to the US FDA 2012‐2020

Abstract: Dosing is a critical aspect of drug development in pediatrics that has led to trial failures and the inability to label the drug for pediatric use by the US Food and Drug Administration. Developing a structured approach for pediatric dose selection requires knowledge of the current approaches and their success or failure. This study describes the current experience with pediatric dosing methods from 2012 to 2020 and had 2 primary objectives: (1) to identify how the initial pediatric dose was selected and (2) t… Show more

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Cited by 12 publications
(23 citation statements)
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“…Balancing simplicity and generalizability, the focus was on keeping the tables as simple as possible. The use of allometric and other scaling methods as alternative to PBPK methods through these tables may reduce resources required to select the initial dose for first-in-child trials and can be used as a structured approach to pediatric dose selection [41]. Additionally, these scaling methods can be used to optimize informative sampling times based on the scaled clearance [42,43].…”
Section: Discussionmentioning
confidence: 99%
“…Balancing simplicity and generalizability, the focus was on keeping the tables as simple as possible. The use of allometric and other scaling methods as alternative to PBPK methods through these tables may reduce resources required to select the initial dose for first-in-child trials and can be used as a structured approach to pediatric dose selection [41]. Additionally, these scaling methods can be used to optimize informative sampling times based on the scaled clearance [42,43].…”
Section: Discussionmentioning
confidence: 99%
“…Nevertheless, the TMDD model described herein provides insights into myostatin coverage in pediatric patients with DMD as compared with healthy adult volunteers. Ensuring that the appropriate dosing rationale and regimen are used in pediatric clinical trials, as well as identifying potential patient subgroups who may be more sensitive to treatment (in terms of efficacy and safety), remains a challenge in pediatric drug development 18,19 . It is therefore essential to accurately characterize the underlying PK/PD relationships, especially in children as these are likely to change as they age.…”
Section: Discussionmentioning
confidence: 99%
“…Various dosing methods may be used to determine pediatric drug dosages, including weight-based and allometric scaling. [21][22][23] However, determining the optimal dosages for use in pediatric patients who are obese is complicated, and may require dedicated studies in patients who are obese. 6,21,24,25 In 1 systematic review of the literature, drug exposure levels in children who were obese, compared with controls who were not obese, was evaluated.…”
Section: Discussionmentioning
confidence: 99%