The global status of bioequivalence trials: a comprehensive clinical trial landscape analysis based on the Trialtrove database

IF 6.5 2区医学 Q1 PHARMACOLOGY & PHARMACY

Drug Discovery Today Pub Date : 2024-11-07 DOI:10.1016/j.drudis.2024.104223

Xiuxin Zhong , Shaojing Lin , Mingxia Deng , Ling Guan

{"title":"The global status of bioequivalence trials: a comprehensive clinical trial landscape analysis based on the Trialtrove database","authors":"Xiuxin Zhong , Shaojing Lin , Mingxia Deng , Ling Guan","doi":"10.1016/j.drudis.2024.104223","DOIUrl":null,"url":null,"abstract":"<div><div>This study presents a comprehensive analysis of the global bioequivalence (BE) trial landscape over the past 21 years, utilizing data from the Trialtrove database. We analyzed 12,450 BE trials conducted from 2003 to 2023, revealing a significant upward trend in trial numbers. Among the analysis, the primary therapeutic areas identified were cardiovascular diseases (23.17%) and metabolic/endocrinology conditions (18.91%). China leads in BE trials, accounting for 57.20% of the total, followed by Russia and the United States. Most trials are sponsored by the industry, predominantly by generic pharmaceutical companies. This study highlights the importance of diverse representation in trial populations to enhance the validity of results. We discuss strategies for improving trial success rates, including preliminary trials and in vitro dissolution testing. Furthermore, the need for international harmonization of generic drug standards is emphasized, along with the potential impact of advanced technologies, such as artificial intelligence, on future BE research.</div></div>","PeriodicalId":301,"journal":{"name":"Drug Discovery Today","volume":"29 12","pages":"Article 104223"},"PeriodicalIF":6.5000,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug Discovery Today","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1359644624003489","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}

引用次数: 0

Abstract

This study presents a comprehensive analysis of the global bioequivalence (BE) trial landscape over the past 21 years, utilizing data from the Trialtrove database. We analyzed 12,450 BE trials conducted from 2003 to 2023, revealing a significant upward trend in trial numbers. Among the analysis, the primary therapeutic areas identified were cardiovascular diseases (23.17%) and metabolic/endocrinology conditions (18.91%). China leads in BE trials, accounting for 57.20% of the total, followed by Russia and the United States. Most trials are sponsored by the industry, predominantly by generic pharmaceutical companies. This study highlights the importance of diverse representation in trial populations to enhance the validity of results. We discuss strategies for improving trial success rates, including preliminary trials and in vitro dissolution testing. Furthermore, the need for international harmonization of generic drug standards is emphasized, along with the potential impact of advanced technologies, such as artificial intelligence, on future BE research.

查看原文本刊更多论文

生物等效性试验的全球现状：基于 Trialtrove 数据库的临床试验综合分析。

XXXXX.

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Drug Discovery Today 医学-药学

CiteScore

14.80

自引率

2.70%

发文量

293

审稿时长

6 months

期刊介绍： Drug Discovery Today delivers informed and highly current reviews for the discovery community. The magazine addresses not only the rapid scientific developments in drug discovery associated technologies but also the management, commercial and regulatory issues that increasingly play a part in how R&D is planned, structured and executed. Features include comment by international experts, news and analysis of important developments, reviews of key scientific and strategic issues, overviews of recent progress in specific therapeutic areas and conference reports.