Recently, it is becoming increasingly difficult to develop innovative drugs. Thus, the role of regulatory science research in drug development and postmarketing settings has become more important. In this article, the authors discuss the roles of regulatory science research at the Pharmaceuticals and Medical Devices Agency (PMDA), which aims to improve public health in Japan.

Download full-text PDF

Source
http://dx.doi.org/10.1177/2168479012469950DOI Listing

Publication Analysis

Top Keywords

regulatory science
12
roles regulatory
8
science drug
8
drug development
8
pharmaceuticals medical
8
medical devices
8
devices agency
8
development pharmaceuticals
4
agency japan
4
japan increasingly
4

Similar Publications

Background: This study aimed to provide a comprehensive review of adverse events (AEs) associated with factor Xa (FXa) inhibitors in pediatric patients.

Methods: We searched PubMed, Embase, Cochrane Library, ClinicalTrials.gov, and the European Union Clinical Trials Register for English-language records from the establishment of the database up to October 17, 2023.

View Article and Find Full Text PDF

Despite frequent reliance on teacher and parent ratings of children's behavior for multi-informant assessment, agreement between teachers' and parents' ratings is low. This study examined the predictive utility of teacher and parent ratings for children's self-regulatory outcomes (i.e.

View Article and Find Full Text PDF

This study aimed to identify shared gene expression related to circadian rhythm disruption in polycystic ovary syndrome (PCOS) and non-alcoholic fatty liver disease (NAFLD) to discover common diagnostic biomarkers. Visceral fat RNA samples were collected from 12 PCOS and 14 non-PCOS patients, a sample size representing the clinical situation and sufficient to capture PCOS gene expression profiles. Along with liver transcriptome profiles from NAFLD patients, these data were analyzed to identify crosstalk circadian rhythm-related genes (CRRGs) between the diseases.

View Article and Find Full Text PDF

Alopecia areata (AA) is an autoimmune condition marked by hair loss, linked to inflammatory processes involving the interleukin-1 receptor type 1 (IL-1R1) pathway. This study aims to explore the relationship between IL-1R1 gene expression, serum IL-1R1 levels, and hsa-miR-19b-3p in relation to AA severity. Using a case-control design, we assessed 100 AA patients and 100 healthy controls, measuring serum IL-1R1 through enzyme-linked immunosorbent assay (ELISA) and analyzing IL-1R1 gene and hsa-miR-19b-3p expression levels via quantitative real-time PCR (qRT-PCR).

View Article and Find Full Text PDF

IL-35 modulates Tfh2 and Tfr cell balance to alleviate allergic rhinitis.

Inflamm Res

January 2025

Department of Otolaryngology, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, 510623, China.

Background: Allergic rhinitis (AR) represents a persistent inflammatory condition affecting the upper respiratory tract, characterized by abnormal initiation of the immunoglobulin E (IgE)-mediated cascade. Follicular helper T (Tfh) cells and regulatory T (Tfr) cells are pivotal in orchestrating the development of IgE production in AR patients. IL-35, an anti-inflammatory cytokine, secreted by various cellular subpopulations.

View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!