Regulatory Perspective Based on Survey of Relationship Between Biopharmaceutical Characteristics and Food Effects on Systemic Pharmacokinetics.

This perspective focuses on the current and future regulatory landscape in Japan regarding food effect studies of orally administered drugs. Our study of new drugs shows that the drugs classified as Biopharmaceutics Classification System (BCS) Class I exert minimal food effects on systemic pharmacokinetics (C and AUC). This work will facilitate discussions to refine drug development and regulatory frameworks regarding the waiver of food effect studies using final formulations.

Characteristics and long-term outcomes of children with perianal Crohn's disease.

Background/aims: The incidence of perianal lesions (PL) in children with Crohn's disease (CD) is higher in East Asia than in Western countries. Early intervention for PL is essential to prevent sphincter dysfunction and ostomy placement. In this study, we aimed to investigate the clinical features, treatment, and consequences of pediatric CD with PL.

Association Between Response Time and Time from Emergency Medical Service Contact with the Patient to Hospital Arrival as well as Survival and Neurological Outcomes in Pediatric Out-of-Hospital Cardiac Arrest.

Objectives: In out-of-hospital cardiac arrest (OHCA), prehospital time is crucial and can be divided into response time, from emergency call to emergency medical service (EMS) contact, and time from EMS contact to hospital arrival. To improve prehospital strategies for pediatric OHCA, it is essential to understand the association between these time intervals and patient outcomes; however, detailed investigations are lacking. The current study aimed to examine the association between response time and time from EMS contact to hospital arrival as well as survival and neurological outcomes in pediatric OHCA.