Some paediatric products require taste masking in order to enhance the acceptability to a paediatric population. What taste masking methods have been used to achieve the required taste masking and what methodology was used to confirm that the taste is masked
Are there any correlations between reporting of adverse events and demographic make-up of the pediatric populations who participated in clinical trials? If so, how well that it is translated into the adverse event occurrence... more »
However, the following warning is included in the FDA-approved prescribing information: "SOLU-CORTEF Sterile Powder is contraindicated for intrathecal administration. Reports of severe medical... more »
• Biomarkers may serve as alternatives to invasive diagnostic techniques (e.g. Liver biopsy in NAFLD), early indicators of disease progression, and predictors of treatment efficacy. Does the pooled database support this?
• Specifically, what is the utility of... more »
Moms should be encourage to breast feeding instead of baby milk formulas which contains allergenic substances.
How to best scale from adults to pediatrics for compounds displaying target-mediated drug disposition? There are little published information, and the proposed method in literature is vague and requires sensitivity analysis. I hope FDA could review historic data and recommend the best strategy.
2. How do critical pediatric ADEs differ for low-income, disadvantaged, and/or minority populations? How does representation bias affect performance of AI/ML pediatric drug safety algorithms?... more »
Some characteristics are known to differ between age groups in aGvHD, such as the... more »
• Considering the recently published paper on the long term complications observed in the TODAY study, long term cardiovascular... more »
• This understanding may be useful in interpreted discrepancy within clinical trials, if any.
• How does global (international) data compare to the FDA pooled database? A collaborative effort... more »
• Can the FDA pooled data be utilized to support Bayesian based trial design?
• Suggest applying commercially available physiologically based PK pediatric models on pooled data to predict PK/PD/dosing for use in drug development. Are there models that are preferred for particular populations (age tiers)?