A5062032148- Health Systems, Economic Evaluations, Quality of Life
- Pharmaceutical Economics and Policy
- Statistical Methods in Clinical Trials
- Pharmacovigilance and Adverse Drug Reactions
- Pharmacy and Medical Practices
- Pharmaceutical studies and practices
- Computational Drug Discovery Methods
- Lung Cancer Treatments and Mutations
- Pharmaceutical industry and healthcare
- Economic and Financial Impacts of Cancer
- Colorectal Cancer Treatments and Studies
- Cancer Genomics and Diagnostics
- Diabetes Treatment and Management
- Biosimilars and Bioanalytical Methods
- Cancer Immunotherapy and Biomarkers
- Biomedical Ethics and Regulation
- Meta-analysis and systematic reviews
- Treatment of Major Depression
- Lung Cancer Research Studies
- Data-Driven Disease Surveillance
- Pharmacogenetics and Drug Metabolism
- Diabetes Management and Research
- Pancreatic and Hepatic Oncology Research
- Statistical Methods and Bayesian Inference
- Peptidase Inhibition and Analysis
Kitasato University
2016-2025
Astellas Pharma (Japan)
2022-2023
Merck & Co., Inc., Rahway, NJ, USA (United States)
2022
Pharmaceuticals and Medical Devices Agency
2018
Kitasato Institute Hospital
2016
Ministry of Health Labour and Welfare
2004-2005
Ministry of Health and Welfare
2000
The current success rate of a drug candidate, from the beginning clinical trial to receiving marketing approval, is about 10%-20%, and it has not changed during past few decades. Therefore, pharmaceutical companies are under pressure select one compound, among many others, with high probability success. differences in features affect their probabilities approval In this study, we examined rates candidates, developed United States, European Union, or Japan, by focusing on four parameters...
Data mining has been introduced as one of the most useful methods for signal detection by spontaneous reports, but data is not always effective in detecting all safety issues. To investigate appropriate situations which routine activities, we analyzed characteristics signals that US Food and Drug Administration (FDA) identified from FDA Adverse Event Reporting System (FAERS).Among FAERS between 2008 1Q 2014 4Q, selected 233 to evaluate this study. We conducted a disproportionality analysis...
Reports have indicated that approval lag for anticancer drugs between Japan and the United States has decreased. However, if this is also true used to treat minor cancers remains unknown. We analyzed approved in from 2006 2016 compare drug based on cancer incidence (major vs. cancers) States. The of had not decreased relative a decade ago. Recently, development strategies resulting longer were by pharmaceutical companies more often than targeting major cancers, leading significant...
Abstract Pharmaceutical companies have several options to evaluate drug‐induced QT prolongation, often referred as pathways, during clinical development. Current regulatory practices recommend achieving high exposure (HCE) for conventional thorough (TQT) studies. An alternative the TQT study, commonly known Q&A 5.1 pathway, recommends a two‐fold HCE margin concentration‐corrected (C‐QTc) analysis. To assess impact of these recommendations, we analyzed margins 166 new active substances...
Drug lag is a serious issue for patients with life-threatening diseases such as cancer. Japan and Korea have been facing large drug lag, despite having market good clinical trial environment. We analyzed lags anticancer drugs between these countries, using the information on 82 approved in United States 2017 2022. The national health insurance coverage status was also investigated. approval defined number of days from date to country interest, used indicator calculated each drug. median all...
ABSTRACT Purpose This study aimed to obtain a better understanding of the characteristics risk management plans (RMP) and background regulatory policies governing them, in European Union (EU) Japan. was done by descriptively comparing safety concerns (SCs) listed RMP examining their relationships with product labeling. Methods Information regarding SCs collected from published both EU Japan for targeted products—all which were commonly approved regions. The concordance rate each between EU‐...
ABSTRACT Companion diagnostics (CDxs) are essential in personalized medicine for oncology, where specific genetic mutations drive treatment decisions. Some differences remain the regulatory frameworks and approval processes CDx between United States (U.S.) Japan. Data were collected from public databases CDxs anticancer drugs approved January 1, 2014, August 15, 2024, both countries. The analysis included initial drug approvals supplemental to examine characteristics of drugs, identify...
Abstract Quantitative decision making using the population pharmacokinetic (PPK) approach is useful not only in drug development but also clinical practice. A previous study investigating labeling of new active substances (NASs) approved between 2012 and 2015 Japan United Sates reported a significant gap percentage providing PPK‐related information (17.6%) States (56.6%). However, whether state Japanese has improved compared with US European Union (EU) after guideline on PPK analysis was...
The unmet medical needs of individuals with very rare diseases are high. clinical trial designs and evaluation methods used for 'regular' drugs not applicable in the development ultra-orphan (<1000 patients) many cases. In order to improve drugs, we examined several points regarding efficient evaluations drug efficacy safety that could be conducted even small sample sizes, based on review reports orphan approved Japan.The data packages 43 Japan from January 2001 December 2014 were...
Background: Saxagliptin statistically significantly increased the risk of hospitalization for heart failure compared with placebo in clinical trial SAVOR-TIMI 53. Neither reason why only saxagliptin among several dipeptidyl peptidase-4 (DPP-4) inhibitors risk, nor implication result has been explained. Objective: To evaluate associated DPP-4 by using an alternative measure to hazard ratio. Methods: We used difference restricted mean survival time (RMST) between and cardiovascular events,...
The internationalization of clinical and regulatory guidelines disease treatment the globalization pharmaceutical industry have led drug development strategies in Japan to shift from bridging studies multinational trials. However, current standard for adequate dose-finding processes may sometimes complicate timely participation these objective this study is investigate different factors that might influence dosage selection Japan. Approved dosages United States during period 2003-2008 were...
Drug development in Japan is shifting from a bridging strategy to global strategy, and the number of multiregional trials which included increasing every year. The Japanese drug regulatory authority requires that data be collected populations, therefore dose-response studies various drugs are frequently conducted Japan. However, current standard for adequate dose-finding processes may sometimes hinder timely participation these trials. We studied approaches review patterns 99 new molecular...
The aim of the present study is to investigate factors affecting intrasubject variability pharmacokinetic (PK) exposure, which affect results bioequivalence (BE) studies. We focused on two factors: absolute oral bioavailability (BA) and acidic nature drugs.Intrasubject coefficient variation (CV) for Cmax AUC was estimated based 90% confidence intervals (CIs) number subjects from fasting BE our investigation. Relationships between CV BA as well drugs were investigated.First, relationship PK...
This article discusses current obstacles to the rapid development of safe and effective treatments for rare cancers, considers measures required overcome these challenges. In order develop novel clinical options which tend remain left out therapeutic because their paucity, efficient recruitment eligible patients, who be widely dispersed across country treated at different centers, is necessary. For this purpose, it important establish cancer registries that are linked with studies, organize...