Therapeutic innovation & regulatory science最新文献_第3页

Adopting a Framework for Rapid Real-World Data Analyses in Safety Signal Assessment. 在安全信号评估中采用快速真实世界数据分析框架。

IF 2 4区医学

Therapeutic innovation & regulatory science Pub Date : 2024-11-01 Epub Date: 2024-09-06 DOI: 10.1007/s43441-024-00694-7

Lu Wang, Negar Golchin, Stephanie von Klot, Claudia A Salinas, Katrin Manlik, Vaishali Patadia, Mary K Miller, Julius Asubonteng, Rachel McDermott, Julie Barberio, Geoffrey Gipson

{"title":"Adopting a Framework for Rapid Real-World Data Analyses in Safety Signal Assessment.","authors":"Lu Wang, Negar Golchin, Stephanie von Klot, Claudia A Salinas, Katrin Manlik, Vaishali Patadia, Mary K Miller, Julius Asubonteng, Rachel McDermott, Julie Barberio, Geoffrey Gipson","doi":"10.1007/s43441-024-00694-7","DOIUrl":"10.1007/s43441-024-00694-7","url":null,"abstract":"The expanding availability of real-world data (RWD) has led to an increase in both the interest and possibilities for using this information in postmarketing safety analyses and signal management. While there is enormous potential value from the safety insights generated through RWD, the analysis preparation, execution, and communication required to reliably deliver the evidence can be time consuming. Since the safety signal assessment process is a regulated and timebound process, any supporting RWD analyses require a rapid turnaround of well-designed and informative results. To address this challenge, a TransCelerate BioPharma working group was formed and developed a framework to help teams responsible for safety signal assessment overcome the challenges of working with RWD rapidly to deliver analyses within regulatory timelines. Here, a previously performed safety assessment was evaluated within the context of the developed framework to illustrate how the framework may be adopted in practice.","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11530479/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142146393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Comparison of Product Features and Clinical Trial Designs for the DTx Products with the Indication of Insomnia Authorized by Regulatory Authorities. 监管机构授权的失眠症适应症 DTx 产品功能和临床试验设计比较。

IF 2 4区医学

Therapeutic innovation & regulatory science Pub Date : 2024-11-01 Epub Date: 2024-09-21 DOI: 10.1007/s43441-024-00684-9

Takashi Hosono, Yuki Niwa, Masuo Kondoh

{"title":"Comparison of Product Features and Clinical Trial Designs for the DTx Products with the Indication of Insomnia Authorized by Regulatory Authorities.","authors":"Takashi Hosono, Yuki Niwa, Masuo Kondoh","doi":"10.1007/s43441-024-00684-9","DOIUrl":"10.1007/s43441-024-00684-9","url":null,"abstract":"Background: Digital therapeutics (DTx) have attracted attention as the substitutes or add-ons to conventional pharmacotherapy and the number of DTx products authorized with the regulatory reviews of the clinical evidence is increasing. Insomnia is one of the major targets of the DTx due to the benefit from cognitive behavioral interventions and several products have been launched in the market with regulatory reviews. However, common features of the products and the clinical evidence required by each regulatory agency have not been investigated.Methods: In this study, we identified the DTx products with the primary indication of insomnia authorized with regulatory reviews of clinical evidence by literature and website searches, and investigated the common features of the products and of the study designs for the pivotal clinical trials.Results: The total of 6 DTx products were identified. The components of cognitive behavioral therapy for insomnia (CBT-I) were identified as common features of the products. All the pivotal clinical trials were randomized, parallel-group, blind studies against insomnia patients. No products have been authorized in multiple countries regardless of the similarity of the features of the products and of the study designs for the pivotal clinical trials.Conclusions: Our study revealed that the components of CBT-I and gold standard design in pivotal clinical trials were adopted in all the DTx products for insomnia authorized with reviews of clinical evidence. At the same time, our findings suggest the needs of internationally harmonized regulatory review and authorization system to facilitate the early patient access to the promising DTx products.","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11530488/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142296139","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Pharmaceutical Company's Choices of Indication for the First Clinical Projects in Oncological Drug Development in the United States. 制药公司对美国肿瘤药物开发首个临床项目适应症的选择。

IF 2 4区医学

Therapeutic innovation & regulatory science Pub Date : 2024-10-31 DOI: 10.1007/s43441-024-00718-2

Can Wu, Shunsuke Ono

{"title":"Pharmaceutical Company's Choices of Indication for the First Clinical Projects in Oncological Drug Development in the United States.","authors":"Can Wu, Shunsuke Ono","doi":"10.1007/s43441-024-00718-2","DOIUrl":"10.1007/s43441-024-00718-2","url":null,"abstract":"We analyzed factors shaping the choice of the lead indication (i.e., cancer type) in the first clinical development projects of new oncological drugs in the United States (US), and how the type of pharmaceutical company is related to this choice. We selected 576 new clinical development projects in the US since 2000 for analysis. These projects were characterized according to three potential perspectives detected by multiple correspondence analysis: the morbidity of the cancer type which corresponds to market size of each cancer type, the company's previous experience with the cancer type, and the company's attitude to development risks. Mega firms tend to choose cancer types with higher morbidity (and large-market), previously experienced cancer types, while diverse small firms choose both major and rare cancers and both high- and low-risk projects, indicating that different sizes of firms utilize different development entry patterns. Common tendencies concerning the choice of lead indication were found across all companies. Cancer types the company had developed and launched in the past were more likely to be chosen; cancer types with high five-year survival rates and those with high competition were less likely to be chosen. The study showed that pharmaceutical companies seem to enter clinical development from cancer types where they can demonstrate their strengths and advantages through experience, depending on each cancer type's different market sizes and development difficulties. The results could provide clues for considering what support measures and incentives are appropriate to balance the efficiency of industrial development and the fulfillment of society's unmet medical needs.","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142558862","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Expert Consensus Recommendations on a Biosimilars Value Framework for the Gulf Cooperation Council Countries. 关于海湾合作委员会国家生物仿制药价值框架的专家共识建议。

IF 2 4区医学

Therapeutic innovation & regulatory science Pub Date : 2024-10-30 DOI: 10.1007/s43441-024-00716-4

Khalid A Alnaqbi, Ahmed Al-Jedai, Mohamed Farghaly, Mohammed A Omair, Anas Hamad, Fatemah M A Abutiban, Ali Al Shirawi, Hanan Al Rayes, Sarah Aldallal, Sahar Fahmy, Steven Simoens

{"title":"Expert Consensus Recommendations on a Biosimilars Value Framework for the Gulf Cooperation Council Countries.","authors":"Khalid A Alnaqbi, Ahmed Al-Jedai, Mohamed Farghaly, Mohammed A Omair, Anas Hamad, Fatemah M A Abutiban, Ali Al Shirawi, Hanan Al Rayes, Sarah Aldallal, Sahar Fahmy, Steven Simoens","doi":"10.1007/s43441-024-00716-4","DOIUrl":"https://doi.org/10.1007/s43441-024-00716-4","url":null,"abstract":"Objective: This paper aims to develop a biosimilar value framework with local stakeholders in Gulf Cooperation Council (GCC) countries.Methods: A convenience sample of ten key opinion leaders from the United Arab Emirates, Kingdom of Saudi Arabia, Kuwait, Oman and Qatar participated in an expert panel meeting in November 2022 that examined factors positively influencing biosimilar adoption in these countries. The discussion was structured around a conceptual biosimilar value framework and an overview of biosimilar policies as derived from a targeted review of the peer-reviewed and grey literature.Results: The expert panel agreed on a biosimilar value framework for the GCC countries that is founded on trust, cost savings and contextual considerations. They emphasized the importance of launching educational initiatives that build trust in and expand knowledge of all stakeholders about biosimilars. This also includes making stakeholders aware of the various value propositions of biosimilars as an instrument to produce, for example, cost savings. Finally, they stressed that biosimilar adoption is influenced by contextual factors such as incentives and implementation efforts.Conclusion: Our proposed biosimilars value framekwork is the first set of recommendations in the Arab countries designed to help policymakers and decision-makers promote biosimilar adoption, both in high-income GCC countries and in low- and middle-income countries.","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142547634","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Abstract Versus Concrete Risk Identification in Clinical Research in Japan: Randomized and Prospective Pilot Research on the Effect of Risk Reduction Activities in a Risk-Based Approach. 日本临床研究中的抽象与具体风险识别：基于风险的方法中降低风险活动效果的随机和前瞻性试点研究。

IF 2 4区医学

Therapeutic innovation & regulatory science Pub Date : 2024-10-28 DOI: 10.1007/s43441-024-00702-w

Hidenobu Kondo, Shih-Wei Chiu, Yukikazu Hayashi, Naoto Takahashi, Takuhiro Yamaguchi

{"title":"Abstract Versus Concrete Risk Identification in Clinical Research in Japan: Randomized and Prospective Pilot Research on the Effect of Risk Reduction Activities in a Risk-Based Approach.","authors":"Hidenobu Kondo, Shih-Wei Chiu, Yukikazu Hayashi, Naoto Takahashi, Takuhiro Yamaguchi","doi":"10.1007/s43441-024-00702-w","DOIUrl":"https://doi.org/10.1007/s43441-024-00702-w","url":null,"abstract":"Background: The risk-based approach (RBA) of clinical trial was first introduced in 2011-2012. RBA necessitates implementing risk reduction activities that are proportionate to risk in order to reduce avoidable quality issues. However, there is no consistent methodology or research for identifying and evaluating risks and planning risk reduction activities. We aimed to evaluate risk reduction activities and their effects by using two risk identification and evaluation methods.Methods: Among the risk identification and evaluation methods, we selected one method with the lowest number of categories for identifying risks [risk assessment form (RAF)] and one with the highest number [risk assessment tool (RAT)]. Each method was used to identify and evaluate risks in and plan risk reduction activities for the research on ponatinib blood concentration and treatment outcome in patients with chronic phase chronic myelogenous leukemia. RAF and RAT can identify risk using abstract questions and a list of concrete risks, respectively. The sites were randomized into two groups to implement planned risk reduction activities using RAF and RAT and to compare the mean of errors and protocol deviation per subject visit between the two groups.Results: The mean of errors per subject visit and the mean of protocol deviation per subject visit were lower in the RAF group than in the RAT group.Conclusions: Our study indicates that risk reductions can be successfully implemented by using a method to identify and evaluate risks in a small number of abstract categories that are critical to quality of clinical research.","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142523190","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Open Innovation and Regulatory Challenges in New Modality Development: The Pivotal Role of Contract Development and Manufacturing Organisations in Advancing Antibody Drugs. 新模式开发中的开放式创新和监管挑战：合同开发和制造组织在推动抗体药物发展中的关键作用。

IF 2 4区医学

Therapeutic innovation & regulatory science Pub Date : 2024-10-28 DOI: 10.1007/s43441-024-00701-x

Hiromu Yoshiura, Yayoi Kawata, Shintaro Sengoku

{"title":"Open Innovation and Regulatory Challenges in New Modality Development: The Pivotal Role of Contract Development and Manufacturing Organisations in Advancing Antibody Drugs.","authors":"Hiromu Yoshiura, Yayoi Kawata, Shintaro Sengoku","doi":"10.1007/s43441-024-00701-x","DOIUrl":"https://doi.org/10.1007/s43441-024-00701-x","url":null,"abstract":"Background: Ensuring regulatory-compliant manufacturing capability is an essential challenge for new treatment modalities, but its internalisation is not easy for pharmaceutical companies, especially start-ups. This study examines the functions and requirements of contracted development and manufacturing organisations (CDMOs) using the development process of antibody medicines as a case study.Methods: Utilizing PubMed, Cortellis and Patent Integration databases, this study delves into publication and contractual trends in monoclonal antibody drugs (mAbs) development, alongside an analysis of patent filings by CDMOs, offering a comprehensive overview of the evolving landscape in mAbs innovation.Results: In the early stages of mAbs development, dedicated bio firms (DBFs) led R&D with superior drug discovery technology but lacked manufacturing capability, which was complemented by CDMOs. This collaboration was an opportunity for CDMOs to expand their capabilities beyond manufacturing technology into antibody drug candidate discovery and structural optimisation technology. From mid-development onwards, it established a technology platform based on these capabilities and developed and established partnerships with existing pharmaceutical companies, including mega pharma.Conclusions: The impact of institutions and regulations on the innovation process was assessed during this development process. These findings are expected to provide valuable insights into the innovation system for new modalities.","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142523191","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Hypocalcemia Event Associated with Denosumab: A Real-World Study from FDA Adverse Event Reporting System (FAERS) Database. 与地诺单抗相关的低钙血症事件：来自 FDA 不良事件报告系统 (FAERS) 数据库的真实世界研究。

IF 2 4区医学

Therapeutic innovation & regulatory science Pub Date : 2024-10-25 DOI: 10.1007/s43441-024-00712-8

Siyuan Gao, Guanhao Zheng, Zhichao He, Lishi Chen, Dengfeng Yan, Zhisheng Lai, Tingfeng Cai, Shijie Hu

{"title":"Hypocalcemia Event Associated with Denosumab: A Real-World Study from FDA Adverse Event Reporting System (FAERS) Database.","authors":"Siyuan Gao, Guanhao Zheng, Zhichao He, Lishi Chen, Dengfeng Yan, Zhisheng Lai, Tingfeng Cai, Shijie Hu","doi":"10.1007/s43441-024-00712-8","DOIUrl":"https://doi.org/10.1007/s43441-024-00712-8","url":null,"abstract":"Background and objective: Denosumab is widely used for osteoporosis and cancer treatment. However, hypocalcemia induced by denosumab is a frequent adverse event. The objective of this study is to comprehensively investigate the safety signals and the occurrence of hypocalcemia in real-world patient cases reported through the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).Methods: Reports from January 1, 2017 to December 31, 2021 were extracted from the FAERS. Only cases of hypocalcemia suspected to denosumab were eligible in pharmacovigilance study. Denosumab-related hypocalcemia safety signal were identified to characterize their clinical features. A safety signal for hypocalcemia was evaluated using reporting odds ratios (ROR).Results: Among the 102,413 cases related to denosumab, 1042 cases were reported with denosumab-related hypocalcemia. The affected patients were mainly elderly (median age 70 years) and male (n = 568, 63.5%). In available data, the median onset time of 23 (range 0-1601) days. Most patients required drug interruption (n = 226, 72.9%) and can achieve a recovered-resolved state (n = 318, 62.1%). For the whole database, denosumab exhibited a safety signal for hypocalcemia (ROR = 14.09, 95% Cl 13.18, 15.06). In the sensitivity analyses, denosumab also showed a safety signal for hypocalcemia in cancer (ROR = 21.28, 95% Cl 18.79, 24.11) and osteoporosis (ROR = 9.29, 95% Cl 6.80, 12.59). Compared with bisphosphonates, denosumab still has safety signal for hypocalcemia (ROR = 1.88, 95% Cl 1.67, 2.11).Conclusions: This pharmacovigilance database analysis indicates a high safety signal for hypocalcemia associated with denosumab, particularly in cancer patients.","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508547","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Provision of Drug Information Using Database Surveys-Enhancing Clinical Information for Patients with Specific Backgrounds. 利用数据库调查提供药物信息--为具有特殊背景的患者提供更多临床信息。

IF 2 4区医学

Therapeutic innovation & regulatory science Pub Date : 2024-10-24 DOI: 10.1007/s43441-024-00715-5

Kiyohito Nakai, Mie Ikeda, Yumiko Nomura

引用次数: 0

Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States. 日本的儿科专用药物流失问题：日本与美国儿科发展状况的比较。

IF 2 4区医学

Therapeutic innovation & regulatory science Pub Date : 2024-10-23 DOI: 10.1007/s43441-024-00714-6

Ryohei Osako, Naoki Matsumaru, Katsura Tsukamoto

{"title":"Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States.","authors":"Ryohei Osako, Naoki Matsumaru, Katsura Tsukamoto","doi":"10.1007/s43441-024-00714-6","DOIUrl":"https://doi.org/10.1007/s43441-024-00714-6","url":null,"abstract":"Background: The lack of label information for the pediatric population has been a global issue, leading to the introduction of several countermeasures by major health authorities. Despite various efforts by Japanese health authorities, some drugs are approved only for adults in Japan, while the United States (US) label includes information on pediatric usage for the same drugs. This suggests a potential for pediatric-specific drug loss in Japan, where overall drug loss has recently become a major concern.Methods: In this study, we compared the pediatric usage status between Japan and the US, focusing on the indications approved in both countries.Results: Of the 404 indications, 70 (17.3%) and 102 (25.2%) included pediatric usage in Japan and the US, respectively. The proportion of indications, including pediatric usage, was significantly higher in the US than in Japan (χ2 test, p < 0.001). Multivariate analysis of indications for pediatric usage in the US demonstrated that simultaneous development with adults (odds ratio (OR), 24.9; 95% confidence interval (CI), 6.79-91.1) and Japan-first development (OR, 31.5; 95% CI, 2.59-384) were significantly affecting the inclusion of pediatric usage in Japan.Conclusions: Our results suggest that there was pediatric-specific drug loss in Japan compared to that in the US. The multivariate analysis demonstrated that US-first development and non-simultaneous development had a negative impact on the inclusion of pediatric usage in Japan; however, pediatric assessment request was not a significant factor. Further frameworks to promote pediatric drug development should be introduced in Japan to address pediatric-specific drug loss issues.","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508548","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A Clustering Ensemble Method for Drug Safety Signal Detection in Post-Marketing Surveillance. 上市后监测中药物安全信号检测的聚类组合方法。

IF 2 4区医学

Therapeutic innovation & regulatory science Pub Date : 2024-10-20 DOI: 10.1007/s43441-024-00705-7

Shubhadeep Chakraborty, Ram Tiwari

{"title":"A Clustering Ensemble Method for Drug Safety Signal Detection in Post-Marketing Surveillance.","authors":"Shubhadeep Chakraborty, Ram Tiwari","doi":"10.1007/s43441-024-00705-7","DOIUrl":"https://doi.org/10.1007/s43441-024-00705-7","url":null,"abstract":"Post-marketing surveillance refers to the process of monitoring the safety of drugs once they reach the market, after the successful completion of clinical trials. In this work, we investigate a computational approach using data mining tools to detect safety signals from post-market safety databases, or in other words, to identify adverse events (AEs) with disproportionately high reporting rates compared to other AEs, associated with a particular drug or a drug class. Essentially, we view this as a problem of cluster analysis-based anomaly detection on post-market safety data, where the goal is to 'unsupervisedly' detect the anomalous or the signal AEs. Our findings demonstrate the potential of using a clustering ensemble method to detect drug safety signals. It employs multiple clustering or anomaly detection algorithms, followed by a performance comparison of the candidate algorithms based on a collection of appropriate measures of goodness of clustering results. The method is general enough to include any number of clustering or anomaly detection algorithms and goodness measures, and performs better than any of the candidate algorithms in identifying the signal AEs. Extensive simulation studies illustrate that the ensemble method detects the AE signals from synthetic post-market safety datasets pretty accurately across the different scenarios explored. Based on the cases reported to the FDA Adverse Event Reporting System (FAERS) between 2013 and 2022, we further demonstrate that the ensemble method successfully identifies and confirms most of the adverse events that are known to occur most frequently in reaction to antiepileptic drugs and <math><mi>β</mi></math> -lactam antibiotics.","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142475472","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0