• 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)?
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
Does CYP2D6 genotype influence ondansetron efficacy and/or toxicity? For example, do patients with a CYP2D6 ultra-rapid metabolizer phenotype experience more treatment failure? Do patients with intermediate or poor metabolizer phenotype experience greater toxicity (e.g., QT prolongation, headache, constipation).
Few data are available regarding the outcomes associated with medications used for pediatric mental health emergencies. Association of medications with adverse outcomes and length of stay would encourage the development of evidenced based guidelines and recommendations.
Does the FDA plan to create a draft guidance on the topic taste assessment or acceptability testing, similar to what FDA provided as a guidance for industry concerning the testing with soft food/vehicles?
Should we dose intrathecal based on csf volume or brain weight or even body weight for pediatric. How this differ across small to large molecules.