Host: The Japanese Society of Toxicology
Name : The 50th Annual Meeting of the Japanese Society of Toxicology
Date : June 19, 2023 - June 21, 2023
Pharmaceutical excipients are valuable substances that enhance the usability of the active ingredient other than pharmacological effects, but the specific attention must be paid to the safety. New excipients are approved together with the active ingredient and are not approved independently. Therefore, in terms of the safety concerns, the daily intake of the excipients in the approved dosage form of the drug must be the harmless, and it can be the precedent case. The new active ingredient can be employed with the excipient of the precedent dosage form as long as it does not interfere with the therapeutic effect. The Japanese precedent cases of excipients are based on the maximum doses that they are taken by adults. Although it is well known that the responses to developing organs, specificity, selectivity, etc. are pharmacologically different in paediatric patients compared to adults, there is not apparent precedent cases for paediatric excipients. The ICH-S11 guideline (Nonclinical safety testing in support of development paediatric pharmaceuticals) is likely to recommend the design of nonclinical studies in juvenile animals with pharmaceuticals and/or new excipients, when the safety information for the paediatric populations is insufficient.
In this poster, as a safety information for the paediatric population in pharmaceutical excipients. We conducted a survey of precedent cases of the excipients in paediatric formulations (for neonates, infants, children, and adolescents). The survery included the dosage form and formulation of the pharmaceutical attachment, the package inserts and new drug review reports. The results are summarized in the tabuar table.
