Purpose: Pharmacovigilance plays a vital role in ensuring that patients receive appropriate medical products that are safe and effective. This paper aims to describe the history of pharmacovigilance in Korea and introduce the establishment and goal of the KIDS.
Methods: In Korea, the adverse drug reactions (ADR) reporting system was launched in 1988 by the Korea Ministry of Food and Drug Safety (MFDS) and spontaneous ADR reports have been collected from health care professionals and the general public. Although the ADR reporting system has begun, the reporting rate was very low in the first 10 years, and safety actions were done passively in response to the US Food and Drug Administration (FDA) or European Medicines Agency (EMA)'s safety alert and communications.
Results: Therefore, the Korea Institute of Drug Safety and Risk Management (KIDS) was established in April 2012 as a new initiative for pharmacovigilance.
Conclusions: The KIDS will continue to contribute to the improvement of Korean pharmacovigilance by collecting, managing, and analyzing consumer-centered drug safety information.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1002/pds.3715 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Efficacy and Safety of Sulforaphane Added to Antipsychotics for the Treatment of Negative Symptoms of Schizophrenia: A Randomized Controlled Trial.
J Clin Psychiatry
January 2025
Nathan S. Kline Institute for Psychiatric Research, Orangeburg, New York, and Department of Psychiatry, New York University School of Medicine, New York, New York.
There are few established treatments for negative symptoms in schizophrenia, which persist in many patients after positive symptoms are reduced. Oxidative stress, inflammation, and epigenetic modifications involving histone deacetylase (HDAC) have been implicated in the pathophysiology of schizophrenia. Sulforaphane has antioxidant properties and is an HDAC inhibitor.
View Article and Find Full Text PDFEfficacy and Safety of BI 1358894 in Patients With Borderline Personality Disorder: Results of a Phase 2 Randomized, Placebo-Controlled, Parallel Group Dose-Ranging Trial.
J Clin Psychiatry
January 2025
Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York.
To provide proof-of-concept (PoC), dose-range finding, and safety data for BI 1358894, a TRPC4/5 ion channel inhibitor, in patients with borderline personality disorder (BPD). This was a phase 2, multinational, randomized, double-blind, placebo controlled trial. Patients were randomized to oral placebo or BI 1358894 (5 mg, 25 mg, 75 mg, or 125 mg) once daily in a 2.
View Article and Find Full Text PDFEfficacy and safety of cefiderocol in the treatment of infections caused by Gram-negative bacteria: a systematic review and meta-analysis.
J Infect Dev Ctries
December 2024
Chengdu Jinjiang District Maternal and Child Healthcare Hospital, Chengdu, China.
Objective: To assess the efficacy and safety of cefiderocol (CFDC) in the treatment of Gram-negative bacteria (GNB) infections.
Methods: Relevant studies were collected from PubMed, Web of Science, Cochrane, and Embase databases, from inception to 15 October 2023. The search formula was as follow: "cefiderocol", "S-649266", "Gram-Negative Bacteria", "Gram Negative Bacteria", "Klebsiella pneumoniae", "Hyalococcus pneumoniae", and "Bacterium pneumoniae proposal".
A Phase I, First-In-Human Study of CBA-1205, an Anti-DLK1 Monoclonal Antibody, in Patients With Advanced Solid Tumors.
Cancer Sci
January 2025
Department of Experimental Therapeutics, National Cancer Center Hospital, Chuo-ku, Japan.
CBA-1205 is a novel humanized antibody targeting delta-like 1 homolog (DLK1) that enhances antibody-dependent cellular cytotoxicity activity. DLK1 overexpression has been reported in various cancer types, such as hepatocellular carcinoma and neuroblastoma. CBA-1205 demonstrates potent antitumor activity in multiple tumor models, making it a potential treatment option for DLK1-expressing cancers.
View Article and Find Full Text PDFA first-in-human study of JNJ-70218902, a bispecific T-cell-redirecting antibody against TMEFF2 in metastatic castration-resistant prostate cancer.
Oncologist
January 2025
Department of Medical Oncology, Princess Margaret Hospital, Toronto, ON M5G 2M9, Canada.
Background: Metastatic castration-resistant prostate cancer (mCRPC) has a poor prognosis, necessitating the investigation of novel treatments and targets. This study evaluated JNJ-70218902 (JNJ-902), a T-cell redirector targeting transmembrane protein with epidermal growth factor-like and 2 follistatin-like domains 2 (TMEFF2) and cluster of differentiation 3, in mCRPC.
Patients And Methods: Patients who had measurable/evaluable mCRPC after at least one novel androgen receptor-targeted therapy or chemotherapy were eligible.
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!