One-year post-acute COVID-19 syndrome and mortality in South Korea: a nationwide matched cohort study using claims data.

Background: Current understanding of post-COVID-19 syndrome in South Korea is primarily based on survey studies or research targeting specific patient groups, such as those hospitalized. Moreover, the majority of relevant studies have been conducted in European and North American populations, which may limit their applicability to the South Korean context. To address this gap, our study explores the one-year outcomes of COVID-19, focusing on the potential post-acute syndrome and all-cause mortality in South Korea.

Automatic Extraction of Comprehensive Drug Safety Information from Adverse Drug Event Narratives in the Korea Adverse Event Reporting System Using Natural Language Processing Techniques.

Introduction: Concerns have been raised over the quality of drug safety information, particularly data completeness, collected through spontaneous reporting systems (SRS), although regulatory agencies routinely use SRS data to guide their pharmacovigilance programs. We expected that collecting additional drug safety information from adverse event (ADE) narratives and incorporating it into the SRS database would improve data completeness.

Objective: The aims of this study were to define the extraction of comprehensive drug safety information from ADE narratives reported through the Korea Adverse Event Reporting System (KAERS) as natural language processing (NLP) tasks and to provide baseline models for the defined tasks.

An annotated corpus from biomedical articles to construct a drug-food interaction database.

Motivation: While drug-food interaction (DFI) may undermine the efficacy and safety of drugs, DFI detection has been difficult because a well-organized database for DFI did not exist. To construct a DFI database and build a natural language processing system extracting DFI from biomedical articles, we formulated the DFI extraction tasks and manually annotated texts that could have contained DFI information. In this article, we introduced a new annotated corpus for extracting DFI, the DFI corpus.

A population pharmacokinetic-pharmacodynamic model of YH12852, a highly selective 5-hydroxytryptamine 4 receptor agonist, in healthy subjects and patients with functional constipation.

YH12852, a novel, highly selective 5-hydroxytryptamine 4 (5-HT ) receptor agonist, is currently under development to treat patients with functional constipation. In this study, we aimed to develop a pharmacokinetic (PK)-pharmacodynamic (PD) model that adequately described the time courses of the plasma concentrations of YH12852 and its prokinetic effect as assessed by the Gastric Emptying Breath Test (GEBT) and to predict the prokinetic effect of YH12852 at higher doses through PD simulation. We used the plasma concentrations of YH12852 from patients with functional constipation and healthy subjects and the GEBT results from healthy subjects obtained from a phase I/IIa trial.

A critical review of the United States regulatory pathways for determining the equivalence of efficacy between CT-P13 and original infliximab (Remicade).

We evaluated the appropriateness of various equivalence margins for CT-P13, an infliximab biosimilar, in the PLANETRA clinical trial. The 95-95% method was used to independently determine an equivalence margin by pooling the historical clinical trials with original infliximab versus placebo, identified in a systematic literature search. The constancy assumption with the PLANETRA trial was assessed for each identified historical clinical trial to decide which study was scientifically justifiable to be pooled.