Frontiers in Drug Safety and Regulation最新文献

{"title":"Measurement error and bias in real-world oncology endpoints when constructing external control arms","authors":"Benjamin Ackerman, Ryan W. Gan, Craig S. Meyer, Jocelyn R. Wang, Youyi Zhang, Jennifer Hayden, Grace Mahoney, Jennifer L. Lund, Janick Weberpals, Sebastian Schneeweiss, James Roose, Juned Siddique, Omar Nadeem, Smith Giri, Til Stürmer, S. Ailawadhi, Ashita S. Batavia, Khaled Sarsour","doi":"10.3389/fdsfr.2024.1423493","DOIUrl":"https://doi.org/10.3389/fdsfr.2024.1423493","url":null,"abstract":"Introduction: While randomized controlled trials remain the reference standard for evaluating treatment efficacy, there is an increased interest in the use of external control arms (ECA), namely in oncology, using real-world data (RWD). Challenges related to measurement of real-world oncology endpoints, like progression-free survival (PFS), are one factor limiting the use and acceptance of ECAs as comparators to trial populations. Differences in how and when disease assessments occur in the real-world may introduce measurement error and limit the comparability of real-world PFS (rwPFS) to trial progression-free survival. While measurement error is a known challenge when conducting an externally-controlled trial with real-world data, there is limited literature describing key contributing factors, particularly in the context of multiple myeloma (MM).Methods: We distinguish between biases attributed to how endpoints are derived or ascertained (misclassification bias) and when outcomes are observed or assessed (surveillance bias). We further describe how misclassification of progression events (i.e., false positives, false negatives) and irregular assessment frequencies in multiple myeloma RWD can contribute to these biases, respectively. We conduct a simulation study to illustrate how these biases may behave, both individually and together.Results: We observe in simulation that certain types of measurement error may have more substantial impacts on comparability between mismeasured median PFS (mPFS) and true mPFS than others. For instance, when the observed progression events are misclassified as either false positives or false negatives, mismeasured mPFS may be biased towards earlier (mPFS bias = −6.4 months) or later times (mPFS bias = 13 months), respectively. However, when events are correctly classified but assessment frequencies are irregular, mismeasured mPFS is more similar to the true mPFS (mPFS bias = 0.67 months).Discussion: When misclassified progression events and irregular assessment times occur simultaneously, they may generate bias that is greater than the sum of their parts. Improved understanding of endpoint measurement error and how resulting biases manifest in RWD is important to the robust construction of ECAs in oncology and beyond. Simulations that quantify the impact of measurement error can help when planning for ECA studies and can contextualize results in the presence of endpoint measurement differences.","PeriodicalId":321587,"journal":{"name":"Frontiers in Drug Safety and Regulation","volume":"104 43","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141821677","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Machine learning analysis of patients’ perceptions towards generic medication in Greece: a survey-based study","authors":"Konstantinos Kassandros, Evridiki Saranti, Evropi Misailidou, Theodora-Aiketerini Tsiggou, Eleftheria Sissiou, George Kolios, Theodoros Constantinides, Christos Kontogiorgis","doi":"10.3389/fdsfr.2024.1363794","DOIUrl":"https://doi.org/10.3389/fdsfr.2024.1363794","url":null,"abstract":"This survey-based study investigates Greek patients’ perceptions and attitudes towards generic drugs, aiming to identify factors influencing the acceptance and market penetration of generics in Greece. Despite the acknowledged cost-saving potential of generic medication, skepticism among patients remains a barrier to their widespread adoption.Between February 2017 and June 2021, a mixed-methods approach was employed, combining descriptive statistics with advanced machine learning models (Logistic Regression, Support Vector Machine, Random Forest, Gradient Boosting, and XGBoost) to analyze responses from 2,617 adult participants. The study focused on optimizing these models through extensive hyperparameter tuning to predict patient willingness to switch to a generic medication.The analysis revealed healthcare providers as the primary information source about generics for patients. Significant differences in perceptions were observed across demographic groups, with machine learning models successfully identifying key predictors for the acceptance of generic drugs, including patient knowledge and healthcare professional influence. The Random Forest model demonstrated the highest accuracy and was selected as the most suitable for this dataset.The findings underscore the critical role of informed healthcare providers in influencing patient attitudes towards generics. Despite the study’s focus on Greece, the insights have broader implications for enhancing generic drug acceptance globally. Limitations include reliance on convenience sampling and self-reported data, suggesting caution in generalizing results.","PeriodicalId":321587,"journal":{"name":"Frontiers in Drug Safety and Regulation","volume":"8 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140227520","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Artificial intelligence for optimizing benefits and minimizing risks of pharmacological therapies: challenges and opportunities","authors":"S. Crisafulli, Francesco Ciccimarra, Chiara Bellitto, Massimo Carollo, Elena Carrara, Lisa Stagi, Roberto Triola, Annalisa Capuano, Cristiano Chiamulera, Ugo Moretti, Eugenio Santoro, Alberto Eugenio Tozzi, Giuseppe Recchia, Gianluca Trifirò","doi":"10.3389/fdsfr.2024.1356405","DOIUrl":"https://doi.org/10.3389/fdsfr.2024.1356405","url":null,"abstract":"In recent years, there has been an exponential increase in the generation and accessibility of electronic healthcare data, often referred to as “real-world data”. The landscape of data sources has significantly expanded to encompass traditional databases and newer sources such as the social media, wearables, and mobile devices. Advances in information technology, along with the growth in computational power and the evolution of analytical methods relying on bioinformatic tools and/or artificial intelligence techniques, have enhanced the potential for utilizing this data to generate real-world evidence and improve clinical practice. Indeed, these innovative analytical approaches enable the screening and analysis of large amounts of data to rapidly generate evidence. As such numerous practical uses of artificial intelligence in medicine have been successfully investigated for image processing, disease diagnosis and prediction, as well as the management of pharmacological treatments, thus highlighting the need to educate health professionals on these emerging approaches. This narrative review provides an overview of the foremost opportunities and challenges presented by artificial intelligence in pharmacology, and specifically concerning the drug post-marketing safety evaluation.","PeriodicalId":321587,"journal":{"name":"Frontiers in Drug Safety and Regulation","volume":"289 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140233321","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Menstrual disorders following COVID-19 vaccination: a review using a systematic search","authors":"V. Smaardijk, Rana Jajou, Agnes Kant, Florence P. A. M. van Hunsel","doi":"10.3389/fdsfr.2024.1338466","DOIUrl":"https://doi.org/10.3389/fdsfr.2024.1338466","url":null,"abstract":"Introduction:Menstrual disorders are commonly reported after COVID-19 vaccination and heavy menstrual bleeding was added to the product information of the COVID-19 vaccines of Moderna and Pfizer. The aim of this review, using a systematic search, is to provide an overview of available literature on the risk of menstrual disorders after COVID-19 vaccination.Methods: The review was conducted according to the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) guidelines. A PubMed search was performed on 15 August 2023, including solely quantitative studies in English and Dutch.Results: A total of 61 studies were included, of which 40 were cross-sectional studies, 18 cohort studies, and three self-controlled case series. Outcomes included a wide variety of menstrual disorders, including changes in cycle length (n = 54), changes in the amount of bleeding (n = 44), changes in menses length (n = 30), changes in the experience of (pre)menstrual pain (n = 21), and breakthrough bleeding (n = 18). All included studies found a higher percentage of at least one menstrual disorder in the first cycle after different types of COVID-19 vaccination and after different doses.Discussion: In conclusion, evidence suggests that COVID-19 vaccines may cause menstrual changes in women of reproductive age. However, there is a need for more longitudinal studies because of important limitations in the study designs of many of the included studies. Although menstrual changes are short-lived and predominantly mild, it is important for women and healthcare professionals to be informed about these potential adverse reactions and to assess these events in clinical trials on vaccines.","PeriodicalId":321587,"journal":{"name":"Frontiers in Drug Safety and Regulation","volume":"169 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140473972","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A review of the prescribing culture of anti-depressants across government districts in Northern Ireland","authors":"M. Ruddock, Joanne Watt, M. Kurth, J. V. Lamont, Laura Mooney, Peter Fitzgerald","doi":"10.3389/fdsfr.2023.1303572","DOIUrl":"https://doi.org/10.3389/fdsfr.2023.1303572","url":null,"abstract":"Introduction: The COVID-19 pandemic has caused a significant increase in mental health issues which general practitioners are now witnessing and managing in communities across Northern Ireland. Unfortunately, this new tsunami of patients with mental health issues has put tremendous strain on our already overburdened health system. As a result, Northern Ireland currently holds the unenviable record for prescribing more anti-anxiety and anti-depressant medication than any other country in the world.Methods: Data was obtained from the Northern Ireland Statistics and Research Agency (NISRA), Family Practitioner Services, General Pharmaceutical Services, Annual Statistics 2020/2021 (published June 2021) and 2021/2022 (published June 2022). Data was analysed by age, gender, district, and socioeconomic class on prescription medication [according to the British National Formulary (BNF)].Results: From 2020/2021 to 2021/2022, the prescribing culture for anti-anxiety and/or anti-depressant medication in Northern Ireland did not abate (24% vs. 14%, female to male, respectively). The postcode and index of multiple deprivation (IMD) was analysed and a mean IMD for each constituency was taken as an estimate of the overall IMD to establish if money spent per patient was related to the IMD in each constituency. North Down, South Antrim, and East Antrim were least deprived, as indicated by their high IMD. Whereas, Foyle, and Belfast West were most deprived (low IMD). The cost of mood and anxiety medication per patient was compared against constituency; patients in Belfast West and Belfast North, followed by Foyle, had the highest costs per patient, and the lowest IMD (most deprived).Conclusion: This review concludes that there has been no change in the prescribing culture for anti-anxiety or anti-depressants across Northern Ireland (2020–2022). The cost of mood and anxiety medication per patient did not correlate with the index of multiple deprivation (IMD). Areas of low IMD trended to have higher spend. Is it now time to review the prescribing culture in Northern Ireland and offer greater support to our GPs to initiate a program of deprescribing and manage the wellbeing of our citizens?","PeriodicalId":321587,"journal":{"name":"Frontiers in Drug Safety and Regulation","volume":"50 23","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138950738","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety of corticosteroid therapy in sarcoidosis treatment","authors":"A. di Marco Berardino, F. Mei, L. Zuccatosta","doi":"10.3389/fdsfr.2023.1319931","DOIUrl":"https://doi.org/10.3389/fdsfr.2023.1319931","url":null,"abstract":"Introduction: Sarcoidosis is a multisystemic granulomatous disease of unknown origin and unpredictable cause, characterized by a dysregulated immune response. If histopathological hallmark is represented by the presence of non-caseating granulomas, clinical manifestations are variable and symptoms are not specific, and they depend on organs affected. Although thoracic involvement (lung and mediastinum) is the most common clinical manifestation, any organ can be virtually affected.Methods: This paper is structured as a narrative review. A literature search was performed in four electronic databases (Pubmed, Cochrane, Scopus, and Ovid Medline) and Google from inception until February 2023 for relevant studies, meta-analyses, and reviews on corticosteroids’ adverse events in sarcoidosis. English language only papers were included.Discussion: Although antimetabolites (such as Methotrexate) and immunosuppressant agents can be used as alternative therapy in refractory cases, traditionally systemic glucocorticoids represent the first choice for sarcoidosis treatment. However, their use is still debated, due to potential adverse effects, leading to a wide spectrum of complications particularly in patients who required long-term therapy. Hence, this article aims to provide a comprehensive updated review on the safety profile of glucocorticoid treatment in patients with sarcoidosis and their systemic effects.Conclusion: corticosteroids remain the first choice in Sarcoidosis, however, due to numerous side effects, dose and duration of treatment should be carefully adjusted and monitored by clinicians.","PeriodicalId":321587,"journal":{"name":"Frontiers in Drug Safety and Regulation","volume":"11 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138974678","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Navigating a transforming landscape: the evolving role of pharmacovigilance physicians in drug development and implications for future challenges and training requirements","authors":"Tarek A. Hammad, Salman Afsar, Herve Le-Louet, Veronique F. Kugener","doi":"10.3389/fdsfr.2023.1257732","DOIUrl":"https://doi.org/10.3389/fdsfr.2023.1257732","url":null,"abstract":"Contrary to the famous quote from Voltaire, “The art of medicine consists in amusing the patient, while nature cures the disease”, medicine has evolved since the 17th century into a multi-faceted scientific field facilitating healing and improving overall wellbeing. One rapidly evolving area within this field is drug safety, also known as pharmacovigilance (PV). PV identifies and evaluates potential risks throughout the life cycle of the drug, minimizing patient exposure to harmful effects and guiding appropriate risk mitigation and management strategies. Timely identification and mitigation of risks not only contribute to patient safety but also allows maximum therapeutic benefits while curtailing economic burden associated with adverse events. In the evolving landscape of drug safety, the role of the PV physicians has emerged as an integral component of drug development. This paper aims to explore the evolving nature of PV physicians’ roles in drug development, highlighting changing landscape in drug development and safety monitoring and attendant changes and advancements in responsibilities, scope, and training implications. To be well-rounded, PV physicians are encouraged to strive to undergo relevant training and education. This would enable them to leverage pertinent complementary fields of science by developing the proficiency to ask the right questions, acknowledge multidisciplinary perspectives, and interpret the overall evidence. While on-the-job training is valuable for gaining experience, building a future safety workforce necessitates more targeted efforts, especially considering that medical school curricula may not readily emphasize the development of skills required for successful PV physician roles. Therefore, academic centers, pharmaceutical companies, and regulatory agencies should increase collaboration to establish hands-on training opportunities through post-doctoral, internship, and fellowship programs, in order to meet the growing demand for well-trained PV physicians.","PeriodicalId":321587,"journal":{"name":"Frontiers in Drug Safety and Regulation","volume":"184 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127365563","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The risk of preterm labor after COVID-19 vaccination before and during pregnancy","authors":"M. de Feijter, L. C. Vissers, L. Davidson, A. Kant, P. Woestenberg","doi":"10.3389/fdsfr.2023.1235051","DOIUrl":"https://doi.org/10.3389/fdsfr.2023.1235051","url":null,"abstract":"Background: Pregnant women have a higher risk of severe illness and adverse pregnancy outcomes due to a SARS-CoV-2 infection. COVID-19 vaccination can prevent (severe) infection. Observational studies are needed to ascertain safety of COVID-19 vaccination during pregnancy.Aim: Estimate whether COVID-19 vaccination during pregnancy is associated with the risk of preterm labor (PL).Methods: In this prospective cohort study, we included 5,910 pregnant women (mean age: 33.0 ± 3.7 years) who entered the Dutch Pregnancy Drug Register between February 2021 and August 2022. Information on COVID-19 vaccinations, PL, and confounders were self-reported using web-based questionnaires. The hazard ratio (HR) on PL, comparing those who received ≥1 COVID-19 vaccine during any moment of pregnancy to those who did not, was estimated using survival analyses with vaccination as time-varying exposure. Additionally, we estimated the risk of PL after COVID-19 vaccination prior to pregnancy, and after COVID-19 vaccination during trimester 1, 2, or 3 of pregnancy.Findings: A total of 5,227 (88%) participants received ≥1 COVID-19 vaccine between gestational week 2 and 37. We observed no statistically significant association of COVID-19 vaccination during pregnancy (adjusted HR = 0.93, 95%CI = 0.59; 1.45) nor of COVID-19 vaccination prior to pregnancy (adjusted HR = 1.09, 95%CI = 0.70; 1.71) with the risk of PL. Moreover, we observed no association between the risk of PL and COVID-19 vaccination in any trimester of pregnancy.Discussion: We demonstrated that COVID-19 vaccination prior to or during pregnancy is not associated with an increased risk of PL.Conclusion: These results add to the growing evidence supporting safety of COVID-19 vaccination during pregnancy.","PeriodicalId":321587,"journal":{"name":"Frontiers in Drug Safety and Regulation","volume":"46 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130480297","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of cardiovascular toxicity of the atezolizumab and bevacizumab combination","authors":"T. Niimura, M. Goda, Koji Miyata, J. Matsumoto, T. Yoshioka, H. Hamano, F. Aizawa, Kenta Yagi, Y. Izawa-Ishizawa, Y. Zamami, K. Ishizawa","doi":"10.3389/fdsfr.2023.1213771","DOIUrl":"https://doi.org/10.3389/fdsfr.2023.1213771","url":null,"abstract":"Introduction: The combination of atezolizumab, an immune checkpoint inhibitor (ICI), and bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, is the first choice for systemic therapy in hepatocellular carcinoma. Immune-related cardiovascular toxicity—myocarditis and pericarditis—are known to occur during ICI treatment. By contrast, VEGF inhibitors (VEGFIs) cause cardiovascular complications such as hypertension and heart failure. Thus, different cardiovascular toxicities have been recognized for ICIs and VEGFIs, but the impact of their combination remains unclear. Here, we aimed to investigate the cardiovascular toxicity profile of atezolizumab in combination with bevacizumab using the World Health Organization adverse event reporting database—VigiBase.Methods: We analyzed data included in VigiBase till December 2022. To evaluate the frequency of reports related to atezolizumab, bevacizumab, and their combinations for 21 adverse events, we calculated the reporting odds ratio and information component. Analyses of the fatality of various cardiovascular toxicities associated with the use of each drug were performed.Results: The database included 84,951, 10,595, and 2,092 reports of treatment with bevacizumab, atezolizumab, and their combination, respectively. The disproportionality signal of hypertension, arterial embolism and thrombosis, supraventricular tachyarrhythmias, heart failure, myocarditis, hemorrhage-related clinical events, venous embolism and thrombosis, cardiomyopathy, respiratory failure with combination regimen of atezolizumab and bevacizumab was detected. Signals of these adverse events were also detected treatment with either atezolizumab or bevacizumab alone. Venous embolism and thrombosis exhibited the highest fatality rate in the two drug combination (12.82%) relative to those of atezolizumab (6.19%) and bevacizumab (4.54%).Discussion: Cardiovascular toxicity, owing to the combination of atezolizumab and bevacizumab, was similar to that of each single agent, and no new safety concerns were observed. Caution should be exercised when combining the two drugs since the fatality rate of thromboembolism increases with combination treatment.","PeriodicalId":321587,"journal":{"name":"Frontiers in Drug Safety and Regulation","volume":"128 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128228007","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mucoadhesive polymers in substance-based medical devices: functional ingredients or what else?","authors":"B. Vigani, S. Rossi, G. Sandri, M. C. Bonferoni, C. Caramella","doi":"10.3389/fdsfr.2023.1227763","DOIUrl":"https://doi.org/10.3389/fdsfr.2023.1227763","url":null,"abstract":"The paper is intended to deal with the regulatory status of the family of substance-based medical devices (SB-MD) which contain mucoadhesive polymers. Mucoadhesive formulations are mainly intended for oral/buccal, gastro-esophageal, nasal, or vaginal administration routes. They contain one or more substances/polymers of either natural, synthetic or semi-synthetic origin endowed with mucoadhesive properties. These are complex substances whose chemical-physical properties are in general well characterized. Hydration and water retaining properties, gel formation, lubricating properties are example of functional characteristics that may be involved in mucosal interaction. However, there are still uncertainties as to the underlaying mechanisms. The idea is to provide support, to the understanding of the prevailing mechanisms of action of the family of SB-MD that exploit mucoadhesion phenomenon to exert the intended therapeutic action. A case study on Hyaluronic acid as a typical representative of mucoadhesive polymers, is presented. The correct understanding of the mechanism of action of the substances/polymers involved in SB-MD is pivotal to a smooth and successful submission to the involved regulatory bodies to a positive assessment and to the final approval.","PeriodicalId":321587,"journal":{"name":"Frontiers in Drug Safety and Regulation","volume":"18 11 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125766486","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}