Drug Safety最新文献

{"title":"Evaluation of Data Quality and Utility of the Japan Drug Information Institute in Pregnancy (JDIIP) Consultation Case Database for Pregnancy Pharmacovigilance.","authors":"Shinichi Matsuda, Naho Yakuwa, Mikako Goto, Manabu Akazawa, Kunihiko Takahashi, Tatsuhiko Anzai, Sachi Koinuma, Izumi Fujioka, Yoriko Miura, Mihoko Ota, Hiroaki Oka, Naoki Nitani, Tomiko Tawaragi, Atsuko Murashima","doi":"10.1007/s40264-025-01554-5","DOIUrl":"10.1007/s40264-025-01554-5","url":null,"abstract":"<p><strong>Introduction: </strong>Ensuring medication safety during pregnancy is crucial for protecting maternal and fetal health. However, fragmented data sources and the lack of comprehensive databases present substantial barriers to effective pharmacovigilance. The Japan Drug Information Institute in Pregnancy (JDIIP) database, which contains data on drug treatment counseling for pregnant women, is expected to help address the lack of comprehensive databases for pregnancy pharmacovigilance (PregPV).</p><p><strong>Objective: </strong>We evaluated the quality and utility of the JDIIP database for PregPV activities, particularly its ability to consolidate and utilize drug-exposure data among pregnant women in Japan.</p><p><strong>Methods: </strong>To assess the quality and utility of the JDIIP database for PregPV, we examined its alignment with 48 core data elements (CDEs) considered critical for PregPV, as recently proposed by a European Union consortium through the ConcePTION Project. We performed a detailed mapping of each CDE definition-including maternal lifestyle factors, drug exposure, and pregnancy outcomes-against the corresponding data elements captured in the JDIIP database.</p><p><strong>Results: </strong>The JDIIP database either directly collected or could derive 38 of the 48 specific items (79%) recommended by the ConcePTION Project. At the category level, the JDIIP database aligned closely with the CDE requirements for database management details, pregnancy details, maternal medical history, pregnancy medication exposure, live/stillborn birth outcomes, and malformation details, achieving coverage of over 80% of the necessary variables in each category. Some categories, such as maternal medical conditions arising during pregnancy and infant complications within the first year of life, showed less alignment, with coverage rates below 50%. Although the JDIIP database provides comprehensive coverage of critical pharmacovigilance elements, data collection for specific variables and categories that better align with the CDE framework can be enhanced to improve alignment with the CDE framework and strengthen pharmacovigilance capabilities.</p><p><strong>Conclusions: </strong>Our findings highlight the potential of the JDIIP database as a valuable resource for advancing PregPV research. Although the collection of certain maternal and infant data elements could be improved, the substantial alignment of the database with established CDEs positions it as a promising tool for advancing PregPV initiatives in Japan.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1035-1046"},"PeriodicalIF":3.8,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12334455/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Characteristics of Drug-RElated Hospitalizations for Nursing HOme Residents: Cross-Sectional RENHO Study.","authors":"Alice Lopez, Chiara Alfarano, Marianne Lepetit, Leila Chebane, Nassima Redjimi, Anaïs Couret, Didier Fabre, Virginie Gardette, Driss Berdaï, Maryse Lapeyre-Mestre, Haleh Bagheri","doi":"10.1007/s40264-025-01556-3","DOIUrl":"10.1007/s40264-025-01556-3","url":null,"abstract":"<p><strong>Background: </strong>Nursing home residents with advancing age are often exposed to polypharmacy, a well-known risk factor for adverse drug reactions (ADRs), which increases the risk of hospitalization. Therefore, we assessed the characteristics of and factors associated with ADR-related emergency department (ED) admissions among nursing home residents.</p><p><strong>Methods: </strong>We carried out a cross-sectional study using the Toulouse University Hospital discharge database to identify nursing home residents ED admissions from 1 April, 2019 to 31 March, 2020. Information was updated for 2 years after inclusion (re-admissions). Emergency department medical files were analyzed to identify factors associated with these admissions (including demographics, functional dependency level, comorbidities, body mass index, ED admission in the previous 12 previous months, and number of drugs).</p><p><strong>Results: </strong>We identified 1514 patients (corresponding to 2024 ED admissions), 409 of whom (27.0%) were admitted at least once for an ADR. Thirty-six nursing home residents were re-admitted in 2020 and/or 2021 for ADRs, half of whom were for the same ADR. The most frequent ADRs were falls (114, 24.3%), hemorrhagic events (106, 22.6%), and constipation (47, 10.0%) involving benzodiazepines and Z-drugs (170, 16.0%), antidepressants (125, 11.9%), antithrombotic drugs (110, 10.3%), and opioids (82, 7.7%). About 12% of ADRs were assessed as avoidable. Factors significantly associated with ADR-related ED admissions were the number of drugs (odds ratio 1.09; 95% confidence interval 1.05-1.13), previous ED admissions (odds ratio 3.47; 95% confidence interval 2.46-4.90), and overweight (odds ratio 1.54; confidence interval 1.15-2.06).</p><p><strong>Conclusions: </strong>Drug-induced iatrogenic disease could lead to ED admission for nursing home residents in approximately one-quarter of cases, 12% of which were assessed as avoidable. A previous history of ED admission and polypharmacy remain key associated factors. The awareness-raising campaigns for health professionals should be strengthened to prevent avoidable drug-induced ADRs.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1047-1061"},"PeriodicalIF":3.8,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12334531/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144526909","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Batoclimab Treatment on LDL-C with and Without Coadministration of Atorvastatin: Results from a Phase I Randomized Study in Healthy Participants.","authors":"Thomas Hardy, Su Liang, Philip Tedeschi, E Lin, Eliot A Brinton, Michael H Davidson","doi":"10.1007/s40264-025-01549-2","DOIUrl":"10.1007/s40264-025-01549-2","url":null,"abstract":"<p><strong>Introduction: </strong>Batoclimab is an anti-neonatal fragment crystallizable receptor monoclonal antibody in clinical development for the treatment of autoimmune diseases. In phase II trials, batoclimab resulted in dose-dependent reductions in pathogenic immunoglobulin G autoantibodies; however, dose-related increases in low-density lipoprotein cholesterol and other lipids were observed.</p><p><strong>Objective: </strong>This study examined the relationship between batoclimab treatment and lipid levels, and whether increases in low-density lipoprotein cholesterol could be mitigated by coadministration with atorvastatin, a widely used cholesterol-lowering agent.</p><p><strong>Methods: </strong>In this phase I, randomized, fixed-sequence, single-blind trial, 70 healthy participants received subcutaneous injections of batoclimab at various doses or placebo for 6 weeks. Open-label oral atorvastatin was coadministered in a subset of participants receiving batoclimab 340 mg or 680 mg weekly, starting 14 days before the first dose of the study drug, and continuing through the 6-week treatment period and 8-week safety follow-up. Key endpoints included changes in lipid parameters and atorvastatin pharmacokinetics.</p><p><strong>Results: </strong>Dose-dependent increases in total cholesterol and low-density lipoprotein cholesterol were observed with batoclimab doses ≥ 255 mg weekly, comparable to previous observations, whereas coadministration of atorvastatin 10 mg or 40 mg daily mitigated these changes. Batoclimab had little effect on atorvastatin pharmacokinetics. Dose-dependent decreases in serum albumin up to 37% were observed with batoclimab doses ≥ 255 mg weekly, returning to near-baseline levels 4 weeks after stopping batoclimab. As expected, coadministration of atorvastatin did not meaningfully impact the albumin level. The majority of adverse events were mild in severity.</p><p><strong>Conclusions: </strong>Atorvastatin can mitigate clinically significant increases in low-density lipoprotein cholesterol that may occur with batoclimab treatment.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"993-1004"},"PeriodicalIF":3.8,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12334480/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143982662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"R Value-Based Criteria Outperform Alkaline Phosphatase Less than Twice Normal in Identifying Hy's Law Cases in Clinical Trials.","authors":"Jasmine Amirzadegan, Edwige Chiogo Vouffo, Ling Lan, Eileen Navarro Almario, Mark I Avigan, Paul H Hayashi","doi":"10.1007/s40264-025-01603-z","DOIUrl":"https://doi.org/10.1007/s40264-025-01603-z","url":null,"abstract":"<p><strong>Background: </strong>It is unknown whether nR value [(ALT or AST/ULN) ÷ (AP/ULN)] ≥ 5 is better than alkaline phosphatase less than twice the upper limit of normal (AP < 2x ULN) in identifying hepatocellular drug-induced liver injury (HC DILI) consistent with Hy's law in clinical trials.</p><p><strong>Objective: </strong>We aimed to compare nR value ≥ 5 and AP < 2x ULN in clinical trial DILI cases with ALT or AST ≥ 3x ULN and total bilirubin (TB) > 2x ULN.</p><p><strong>Methods: </strong>We retrospectively categorized clinical trial, DILI cases from July 2020 to April 2024 with ALT or AST ≥ 3x ULN and jaundice as meeting nR value ≥ 5, AP < 2x ULN, both, or neither. We determined positive predictive values (PPVs) and sensitivities for HC DILI-related fatality (death or liver transplant) and acute liver failure (ALF).</p><p><strong>Results: </strong>Of 1314 liver injuries across 73 drug applications, 294 (22%) were attributed to DILI; 55 had ALT or AST ≥ 3x ULN and TB > 2x ULN. We excluded three cases (Gilbert's, high baseline enzymes, hepatitis B reactivation). Of 52 remaining, 16 (31%) met nR ≥ 5, five (10%) AP < 2x ULN, 21 (40%) both, and 10 (19%) neither. There were four DILI fatalities. Excluding one cholestatic fatality, nR ≥ 5 and AP < 2x ULN had PPVs for HC DILI fatality of 8 and 4%, respectively; sensitivities were 100 and 33%, respectively. One patient survived HC DILI-related ALF. Including this ALF case with the fatalities, nR ≥ 5 and AP < 2x ULN had PPVs of 11 and 4%, respectively; sensitivities were 100 and 25%, respectively. All fatalities and ALF cases were due to different drugs.</p><p><strong>Conclusion: </strong>While the number of cases with the most severe DILI outcomes was small, particularly those that resulted in fatalities or ALF, nR ≥ 5 better approximated Hy's Law and was more sensitive than AP < 2x ULN in detecting fatalities and ALF.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144946770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"External Comparator Studies: Performance of Four Missing Data-Handling Approaches, Stratified by Four Different Marginal Estimators.","authors":"Gerd Rippin, Héctor Sanz, Wilhelmina E Hoogendoorn, Joan A Largent","doi":"10.1007/s40264-025-01586-x","DOIUrl":"https://doi.org/10.1007/s40264-025-01586-x","url":null,"abstract":"<p><strong>Background and objective: </strong>Missing data and unmeasured confounding may bias results of external comparator (EC) studies. Previous research quantified these effects, but there were still knowledge gaps in terms of studying a broader set of missing data-handling approaches. This knowledge gap is addressed by investigating four different ways to handle missing data for a set of four distinct marginal estimators.</p><p><strong>Methods: </strong>An extensive simulation study was conducted based on two real EC case studies. Four different variants of missing data-handling approaches were assessed in terms of bias and other performance characteristics. Specifically, multiple imputation (MI) for the trial and EC cohorts was conducted by applying within-cohort MI, across-cohort MI and a mixed within-across-cohort MI scheme. Dropping a covariate from the analysis model if missingness exceeded a certain threshold was also added as an analysis strategy. All simulation results were generated for a set of four marginal estimators: the average treatment effect of the untreated (ATU), the average treatment effect (ATE), the average treatment effect of the treated (ATT), and the average treatment effect in the overlap population (ATO). Missingness was simulated to occur only in the EC cohort, and propensity score weighting was applied as causal inference method.</p><p><strong>Results: </strong>Overall, within-cohort MI and the ATU showed best performance in terms of mitigating bias, while the strategy of leaving out prognostic factors (covariates) due to a higher percentage of missingness performed worst.</p><p><strong>Conclusions: </strong>Performances of four missing data-handling strategies were assessed for a set of four different marginal estimators. Our results add clarity with regard to potential residual bias for researchers conducting EC studies when using propensity score weighting in the case of missing data or unmeasured confounding. This enables researchers to select most appropriate statistical approaches to minimise bias, potentially by including an additional bias estimation and correction step.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144946758","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Navigating Medical Device Safety: Current Status, Challenges, and Future Regulatory Directions.","authors":"Omar Aimer, Catherine Baldridge","doi":"10.1007/s40264-025-01599-6","DOIUrl":"https://doi.org/10.1007/s40264-025-01599-6","url":null,"abstract":"<p><p>Medical devices are indispensable in modern healthcare. They enable the prevention, diagnosis, and treatment of diseases while enhancing patient outcomes. However, the increasing complexity of these devices, particularly those incorporating advanced technologies such as artificial intelligence (AI) introduces new challenges to their safe use. The vulnerabilities of medical devices can lead to adverse events ranging from minor complications to severe injuries or fatalities, and there is an increasing health risk to those devices that are interconnected to electronic health management systems and internet protocols. Despite efforts by regulatory authorities such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada, disparities in reporting systems and monitoring practices persist globally, hindering effective safety oversight. This paper explores the current landscape of medical device safety, focusing on regulatory frameworks, reporting systems, and the challenges posed by fragmented data collection and underreporting. It highlights the critical role of postmarket surveillance (PMS) in identifying risks and ensuring device performance in real-world settings. The integration of emerging technologies, such as AI for predictive safety and blockchain for traceability, offers promising solutions to enhance monitoring and mitigate risks early in the device lifecycle. In addition, the paper examines harmonization efforts led by organizations such as The International Medical Device Regulators Forum (IMDRF), the International Society of Pharmacovigilance (ISoP) and the World Health Organazition (WHO), which aim to standardize reporting practices and improve global collaboration. Key recommendations include leveraging real-world data, enhancing cybersecurity measures, and fostering international cooperation to streamline regulatory processes. By addressing these challenges and embracing innovation, stakeholders can ensure that medical devices continue to advance healthcare while maintaining the highest safety standards. Such collective efforts are essential for safeguarding patient trust and improving global health outcomes.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144946709","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Extent and Magnitude of Bias in Case-Crossover Studies of Real-World Non-transient Medications Patterns: A Simulation Study with Real-World Examples.","authors":"Hsiao-Ching Huang, Mina Tadrous, Saria Awadalla, Daniel Touchette, Glen T Schumock, Todd A Lee","doi":"10.1007/s40264-025-01597-8","DOIUrl":"https://doi.org/10.1007/s40264-025-01597-8","url":null,"abstract":"<p><strong>Introduction: </strong>A case-crossover study is a self-controlled design most appropriate for evaluating transient medication exposures. However, it has increasingly been used in studies of chronic medications and can cause bias in effect estimates that vary based on the pattern of medication use. The goal of this study was to evaluate the magnitude of this bias across different medication-use patterns.</p><p><strong>Objective: </strong>To quantify the magnitude of the bias introduced by different medication patterns and evaluate different case-crossover approaches to mitigate the bias.</p><p><strong>Methods: </strong>We conducted a simulation study evaluating the bias introduced by (1) seven common medication patterns separately, and (2) cohort with 15 different patterns combined. We evaluated each scenario under risk ratios of 0.50, 0.75, 1.00, 1.50, and 2.00. Each approach was analyzed using conditional logistic regression comparing the probability of exposure on the outcome day to 30 days prior. A case-time-control design was used in each of the scenarios. Sensitivity analysis was performed to evaluate the impact on the estimates when changing the length of the risk and control windows. We conducted a real-world example focusing on sodium-glucose co-transporter-2 inhibitor users as real-world examples.</p><p><strong>Results: </strong>The case-crossover design resulted in unbiased estimates when patterns were consistent with transient exposures but were biased upward with prolonged exposure patterns. The magnitude of the bias varies by patterns or pattern combinations. When evaluating prolonged exposures individually or combined as a cohort with mixture patterns, case-time-control with extended risk and control window (30 days) produced unbiased results (mean bias ≤ 0.03).</p><p><strong>Conclusion: </strong>Researchers who use the case-crossover design to evaluate non-transient exposures should implement recommended methods to account for biases.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144834507","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advancing Pharmacovigilance Practice in Africa: Moving from Data Collection to Data-Driven Decision Making-Report from the 5th ISoP Africa Chapter Meeting.","authors":"Helen Byomire Ndagije, Sheila Ampaire, George Tsey Sabblah, Comfort Ogar, Jayesh Manharlal Pandit, Nimisha Kotecha, Mulugeta Russom, Victoria Prudence Nambasa, Claris Ambale, Dorothy Aywak, Peter U Bassi, Wangui Mathenge, Johanna C Meyer, Christabel Khaemba, Emmaculate Kwikiriza, Julius Mayengo, Joanitah Atuhaire, David Nahamya, Omar Aimer, Angela Caro-Rojas","doi":"10.1007/s40264-025-01598-7","DOIUrl":"https://doi.org/10.1007/s40264-025-01598-7","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144811946","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacovigilance in Cell and Gene Therapy: Evolving Challenges in Risk Management and Long-Term Follow-Up.","authors":"Emile Youssef, Kari Weddle, Lisa Zimmerman, Dannelle Palmer","doi":"10.1007/s40264-025-01596-9","DOIUrl":"https://doi.org/10.1007/s40264-025-01596-9","url":null,"abstract":"<p><p>Cell and gene therapies, including CAR T-cells, CRISPR-based genome editing, and next-generation viral and non-viral delivery platforms, are transforming treatment paradigms across cancer, rare genetic disorders, immune dysregulation, and neurodegenerative disease. These therapies offer curative potential but also present safety challenges owing to prolonged biological activity, systemic immune engagement, and lasting genomic alterations. This review examines the range of related toxicities, including immune complications, genotoxicity, and organ-specific effects, with attention to atypical presentations, gaps in clinical trial safety capture, and disparities in global long-term follow-up infrastructure. Central to our analysis is a risk-adaptive, digitally enabled pharmacovigilance model that incorporates real-world data, artificial intelligence-based signal detection, and seamless pediatric-to-adult follow-up to proactively protect patients while supporting innovation. Integrated safety dashboards, pediatric transition roadmaps, and predictive monitoring tools are proposed as practical solutions to improve coordination among sponsors, regulators, and clinical sites. We also outline best practices for aligning risk evaluation and mitigation strategies with risk management plans and examine how wearable biosensors, electronic patient-reported outcomes, and multi-omics biomarkers contribute to near real-time safety surveillance. Ethical priorities such as informed consent, data privacy, and equitable access are addressed throughout. By positioning pharmacovigilance as a proactive and predictive foundation within the therapeutic landscape, this review offers a forward-looking blueprint to advance innovation while ensuring long-term patient safety.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144811948","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Meeting Report: Herbal and Dietary Supplement Safety Surveillance Summit.","authors":"Dina Halegoua-DeMarzio, Andrew Stolz, Bharati Avula, Ikhlas Khan, Victor Navarro","doi":"10.1007/s40264-025-01589-8","DOIUrl":"https://doi.org/10.1007/s40264-025-01589-8","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144811947","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}