Publications by authors named "T Katsube"
Application of model-informed drug development (MIDD) for dose selection in regulatory submissions for drug approval in Japan.
J Pharmacokinet Pharmacodyn
January 2025
Model-informed drug development (MIDD) is an approach to improve the efficiency of drug development. To promote awareness and application of MIDD in Japan, the Data Science Expert Committee of the Drug Evaluation Committee in the Japan Pharmaceutical Manufacturers Association established a task force, which surveyed MIDD applications for approved products in Japan. This study aimed to reveal the trends and challenges in the use of MIDD by analyzing the survey results.
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- A 78-year-old man with heart failure and severe mitral regurgitation underwent mitral valve replacement and coronary artery bypass grafting due to complex heart disease related to atheromatous aorta.
- The surgery was performed using mild hypothermia and systemic hyperkalemia while avoiding an aortic clamp to prevent neurological complications.
- The procedure was successful, and the patient had no neurological issues, being discharged 15 days post-surgery.
Article Synopsis
- Radiation exposure, particularly from radiotherapy and nuclear accidents, carries serious health risks, but certain dietary ingredients may help protect against these effects.
- This review discusses how various vitamins, minerals, and antioxidants can influence radiation sensitivity, acting as either radioprotectors or radiosensitizers in cancer treatment.
- Promising dietary components like vitamins C and E, selenium, and compounds such as curcumin and resveratrol, can reduce oxidative stress, inflammation, and DNA damage, potentially improving the effectiveness of radiation therapy while minimizing side effects.*
Background: Multidrug-resistant Gram-negative bacterial infections are increasing globally in neonates, infants and children; antibiotic options are limited.
Methods: This international, multicenter, open-label phase 2 study, investigated the pharmacokinetics, safety and tolerability of single-dose and multiple-dose cefiderocol [as a 3-hour infusion (every 8 hours) dosed at 2000 mg for body weight ≥34 kg and at 60 mg/kg for body weight <34 kg], over a range of renal function, in hospitalized pediatric patients with aerobic Gram-negative bacterial infection; multiple-dose patients required standard-of-care systemic antibiotics for 5-14 days. Four cohorts of pediatric patients were enrolled (cohort 1: 12 to <18 years, cohort 2: 6 to <12 years, cohort 3: 2 to <6 years and cohort 4: 3 months to <2 years).
When planning pediatric clinical trials, optimizing the sample size of neonates/infants is essential because it is difficult to enroll these subjects. In this simulation study, we evaluated the sample size of neonates/infants using a model-based optimal approach for identifying their pharmacokinetics for cefiderocol. We assessed the usefulness of data for estimation performance (accuracy and variance of parameter estimation) from adults and the impact of data from very young subjects, including preterm neonates.
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