Annales pharmaceutiques francaises最新文献

[The medical biologist "under the microscope" : analysis of digital images depicting laboratory medicine]. [显微镜下的医学生物学家：描述实验室医学的数字图像分析]。

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Annales pharmaceutiques francaises Pub Date : 2025-03-14 DOI: 10.1016/j.pharma.2025.03.003

Bertrand Lefrère, Lionel Barrand, Jean-Louis Beaudeux

{"title":"[The medical biologist \"under the microscope\" : analysis of digital images depicting laboratory medicine].","authors":"Bertrand Lefrère, Lionel Barrand, Jean-Louis Beaudeux","doi":"10.1016/j.pharma.2025.03.003","DOIUrl":"https://doi.org/10.1016/j.pharma.2025.03.003","url":null,"abstract":"In France, the practice of laboratory medicine has, over the past ten years or so, met with a certain amount of disenchantment from medical students. Despite its intricacy and importance to healthcare, the world of the clinical laboratory lacks visibility in medical studies. While other phenomena can explain this disenchantment, our belief in the importance of promoting greater visibility of laboratory medicine in medical studies led us to examine for this article the images and symbols associated with the profession, based on a semiotic analysis. We created a collection of digital images published over the last ten years and found that these images, aside from a few outliers, offer a fairly reasonable representation of the analytical dimension of laboratory medicine. However, we found that this collection of images does not reflect the wealth of specialities, technological complexity and other important aspects of the practice of laboratory medicine especially regarding the clinical staff. Furthermore, we found that clinical interactions (i.e., interactions with patients or doctors), remain, with a few exceptions, absent from most of the images, raising questions about the impact of the images on medical students' perceptions of the profession.","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143639491","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}

引用次数: 0

Pharmacological and Herbal Approach to Diabetes Mellitus Type 2 Management: A Comparative Analysis of Conventional Therapy and Alternative Remedy.

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Annales pharmaceutiques francaises Pub Date : 2025-03-12 DOI: 10.1016/j.pharma.2025.03.002

Zahra Shareef, Afsana Murtaza, Ghousia Fatima, Amjad Islam Aqib, Zahid Manzoor, Muhammad Sibghat Ullah Malik, Hafiz Iftikhar Hussain

{"title":"Pharmacological and Herbal Approach to Diabetes Mellitus Type 2 Management: A Comparative Analysis of Conventional Therapy and Alternative Remedy.","authors":"Zahra Shareef, Afsana Murtaza, Ghousia Fatima, Amjad Islam Aqib, Zahid Manzoor, Muhammad Sibghat Ullah Malik, Hafiz Iftikhar Hussain","doi":"10.1016/j.pharma.2025.03.002","DOIUrl":"https://doi.org/10.1016/j.pharma.2025.03.002","url":null,"abstract":"Diabetes mellitus is a heterogeneous metabolic disorder that affects the metabolism of protein, fats, and carbohydrates due to the destruction of beta-cells resulting disruptions in insulin action/insulin secretion. According to International Diabetes Federation (IDF) prevalence of 90% people with diabetes has type 2 diabetes is driven by socio-economic, demographic, environmental, and genetic factors. DM type 2 sparks myriad of debilitating disease needs management to cure it. Management needs multifactorial authentication including diet, lifestyle and pharmaco-therapy. Literature reveals, metformin is the first line of medication used to cure diabetes Mellitus type 2, also associated with contraindications and adverse effects which spark the interest in alternative herbal remedies. This review will compare pharmacological therapy (Metformin) with alternative herbal remedies (Moringa oleifera) in the management of diabetes mellitus type 2 including in mechanism, dosing relationship consequential effect. According to various guidelines and recommendations, Moringa oleifera is herbal remedy to exhibit anti-diabetic properties by enhancing insulin sensitivity and glucose regulation, reducing oxidation stress and inhibiting free radicals. Significant outcomes suggest that moringa leaf extract is a valuable adjoining therapy with safety high profiling with fewer or no side effects as compared to metformin. There is a need for alternative approaches to diabetes management due to side effects of pharmacological therapies. This review paper will also demonstrate the potential of alternative remedy (Moringa oleifera) in the management of DM type 2 and to what extent its dosing is related to efficacy and safety as compared to the pharmacological approach (Metformin).","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630121","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}

引用次数: 0

Regulatory Frameworks and Filing Discrepancies in Generic Drug Approvals: A Cross-Regional Study with Analysis of FDA ANDA Deficiencies.

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Annales pharmaceutiques francaises Pub Date : 2025-03-10 DOI: 10.1016/j.pharma.2025.03.001

Jyoti Pawar, Namita Hegde, Sanjay Sharma

{"title":"Regulatory Frameworks and Filing Discrepancies in Generic Drug Approvals: A Cross-Regional Study with Analysis of FDA ANDA Deficiencies.","authors":"Jyoti Pawar, Namita Hegde, Sanjay Sharma","doi":"10.1016/j.pharma.2025.03.001","DOIUrl":"https://doi.org/10.1016/j.pharma.2025.03.001","url":null,"abstract":"Objectives: This research aims to analyse the regulatory frameworks for generic drug applications in the US, EU, India, Japan, and China comparing their filing requirements to identify gaps and areas for harmonization. Additionally, it focuses on examining common deficiencies in ANDA from FDA submissions in 2014-2023 to address issues, facilitating more efficient approvals and minimizing delays.Material and methods: The research involved analysing regulatory documents available on official websites, including the FDA, EMA, CDSCO, PMDA, and NMPA to achieve first objective. For second objective a recurring common deficiency across key review disciplines such as bioequivalence, labelling and chemistry was identified through a detailed analysis of deficiency letters available on the FDA website. A targeted analysis was conducted on ANDA submissions filed between 2014 and 2024.Results: A total of 172 deficiencies were identified, with Bioequivalence (35%), Chemistry (34%), and Labeling (31%). Method Validation had the most deficiencies, especially non-compliance with FDA guidelines. In the labeling discipline, the most common deficiency was non-compliance with Reference Listed Drug (RLD) labeling. Comparisons with EMA and WHOPQTm revealed similarities in common deficiencies.Conclusion: This descriptive study highlights regulatory frameworks for generics share significant differences in practical requirements. A harmonized approach could enhance efficiency and standardized submissions. Bioequivalence issues were the most prevalent, with chemistry-related deficiencies, while labeling issues were the least common seen in ANDA applications. This offer concern to manufacturers for dossier compilation, aiming to accelerate generic drug registration.","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143613233","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}

引用次数: 0

[European pharmacovigilance of advanced therapy medicinal products].

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Annales pharmaceutiques francaises Pub Date : 2025-02-27 DOI: 10.1016/j.pharma.2025.02.011

Nadine Petitpain, Viktoryia Prontskus, Mélanie Gauthier, Lena Loutterbach, Cécile Pochon, Jean Hugues Dalle, Danièle Bensoussan

{"title":"[European pharmacovigilance of advanced therapy medicinal products].","authors":"Nadine Petitpain, Viktoryia Prontskus, Mélanie Gauthier, Lena Loutterbach, Cécile Pochon, Jean Hugues Dalle, Danièle Bensoussan","doi":"10.1016/j.pharma.2025.02.011","DOIUrl":"10.1016/j.pharma.2025.02.011","url":null,"abstract":"Advanced therapy medicinal products (ATMPs) are playing an increasingly important role in therapeutics, and sometimes represent the only hope of improving or even curing some pathologies. Because of their biological origin, composition, mode of action, and their frequent technical complexity, ATMPs are potentially generating new risks. Moreover, clinical trial data generally concern only a very small number of patients. The pharmacovigilance of ATMPs must adapt to these constraints and to these new identified or potential risks to be authorized according to an European centralized procedure. The conception and the assessment of the Risk Management Plan are essential to complete routine pharmacovigilance with post-authorization studies and additional risk minimisation measures adapted to the identified safety concerns. This article provides an overview of existing ATMPs and their specific regulatory pharmacovigilance requirements, involving the role of the European committees. It aims to describe the essential elements of the risk management plan of ATMPS, with a focus on delayed adverse reactions. The particular case of ATMPs prepared in the context of « hospital exemption », is also addressed, with the example of ATMPs for adoptive immunotherapy.","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143536558","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}

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Solubility and thermodynamic properties of amlodipine besylate in two binary mixtures of n-methyl pyrrolidone+1-propanol/2-propanol at different temperatures.

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Annales pharmaceutiques francaises Pub Date : 2025-02-26 DOI: 10.1016/j.pharma.2025.02.009

Seyedmahdi Naghavi Kalajahi, Elaheh Rahimpour, Abolghasem Jouyban

引用次数: 0

Biosensors in Wearable Medical Devices: Regulatory Framework and Compliance across US, EU, and Indian Markets.

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Annales pharmaceutiques francaises Pub Date : 2025-02-26 DOI: 10.1016/j.pharma.2025.02.007

Vaishnavi Pawnikar, Mital Patel

{"title":"Biosensors in Wearable Medical Devices: Regulatory Framework and Compliance across US, EU, and Indian Markets.","authors":"Vaishnavi Pawnikar, Mital Patel","doi":"10.1016/j.pharma.2025.02.007","DOIUrl":"https://doi.org/10.1016/j.pharma.2025.02.007","url":null,"abstract":"Biosensors play a crucial role in the diagnosis and monitoring of diseases as therapeutic applications that come with ease through incorporation and collaboration with wearable medical devices. Various regulatory markets are implementing development and management strategies for this emerging medical device field. This paper provides regulatory navigation of biosensors in wearable diagnostic devices across the US, EU, and Indian markets. The regulatory structure of all three countries differs from their origination and management which is discussed in this article along with the regulatory requirements applicable to such devices. The study also focuses on areas such as Good Manufacturing Practices (GMP), risk-based device classification, validation, and post-market surveillance. Key highlights include understanding regulatory authorities, guidelines, rules, regulations, and standards; comparison of regulatory perspectives between the three markets; application of biosensors in medical devices; prospects and market size. The study identifies approval pathways, regulatory challenges, and harmonization efforts across the globe. The paper explores recent advancements in biosensors for health interventions, such as personalized medicine, collaboration with the IoT, biomedical applications, and their accessibility.","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143530952","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}

引用次数: 0

Topical formulation for wound management in animals: A paradigm shifts from conventional to advance.

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Annales pharmaceutiques francaises Pub Date : 2025-02-26 DOI: 10.1016/j.pharma.2025.02.008

Sunita Nirban, Manisha Pandey, Sumit Kumar

{"title":"Topical formulation for wound management in animals: A paradigm shifts from conventional to advance.","authors":"Sunita Nirban, Manisha Pandey, Sumit Kumar","doi":"10.1016/j.pharma.2025.02.008","DOIUrl":"https://doi.org/10.1016/j.pharma.2025.02.008","url":null,"abstract":"Chronic wounds are a significant clinical problem for the healthcare system and require several intensive efforts to improve alternative drug delivery systems for wound care. Sometimes, this is insufficient to support the healing process. There are several obstacles to effective wound therapy, such as poor healing, off-targeting, noncompliance, and frequent dosage. Animal healthcare is a much-needed service for pet owners, farmers, and government agencies. However, the varied physiology of animals presents a challenge in producing effective medicines for animal health. To improve drug therapeutic performance, reduce animal stress, and minimize adverse effects, the industry focuses on current developments in technology for wound management in animals. The literature search utilized various reviews, research articles, clinical trials, case reports, etc. Search engines like Google Scholar, PubMed, and ScienceDirect were used to retrieve data. Various keywords such as \"wound dressing and animals\", \"antimicrobials and animal wounds\", \"wound healing and animals\" etc. were used to search the literature. Different formulation avenues are being explored, including hydrogels, wafers, and nanoemulsions. Therefore, further research is necessary to explore wound healing techniques. Utilising various advanced drug delivery systems for veterinary medicine has significantly reduced adverse effects, the frequency of doses, and stress on animals, resulting in increased profits for the industry. However, this also requires investment in research to ensure the safety, quality, and effectiveness of drugs, and delivery systems. This article reviews the various phases involved in wound healing, multiple factors affecting wound healing, different wound healing approaches, clinical trials, and case studies.","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143530960","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}

引用次数: 0

Photodynamic anti-cancer therapy and arachidonic acid metabolism: State of the art in 2024. 光动力抗癌疗法与花生四烯酸代谢：2024 年的技术水平。

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Annales pharmaceutiques francaises Pub Date : 2025-02-26 DOI: 10.1016/j.pharma.2025.02.010

Hicham Wahnou, Youness Limami, Raphaël Emmanuel Duval, Bassel Ismail, David Yannick Léger, Vincent Sol, Bertrand Liagre

{"title":"Photodynamic anti-cancer therapy and arachidonic acid metabolism: State of the art in 2024.","authors":"Hicham Wahnou, Youness Limami, Raphaël Emmanuel Duval, Bassel Ismail, David Yannick Léger, Vincent Sol, Bertrand Liagre","doi":"10.1016/j.pharma.2025.02.010","DOIUrl":"10.1016/j.pharma.2025.02.010","url":null,"abstract":"Photodynamic therapy (PDT) has emerged as a promising and evolving modality in cancer treatment leveraging light-sensitive compounds known as photosensitizers to selectively induce cell death in malignant tissues through the generation of reactive oxygen species (ROS). This review delves into the intricate mechanisms of PDT highlighting the pivotal role of photosensitizers and the resultant oxidative stress that damages cancer cells. It explores the versatile applications of PDT across various cancer types alongside the advantages and limitations inherent to this therapy. Recent technological advancements including improved photosensitizers and novel light delivery systems are also discussed. Additionally the review examines the critical role of arachidonic acid (AA) metabolism in cancer progression detailing the cyclooxygenase, lipoxygenase and cytochrome P450 pathways and their contributions to tumor biology. By elucidating the interplay between PDT and AA metabolism the review underscores the potential of targeting AA metabolic pathways to enhance PDT efficacy. Finally it provides clinical and translational perspectives highlighting ongoing research and future directions aimed at optimizing PDT for improved cancer treatment outcomes.","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143530955","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}

引用次数: 0

[Training healthcare teams of a multi-site university hospital on high-alert medication issues: Using an escape room].

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Annales pharmaceutiques francaises Pub Date : 2025-02-25 DOI: 10.1016/j.pharma.2025.02.006

Pierre Leroux, Caroline Castera-Ducros, Laurence Conreur, Said Ait Taleb, Adja Fatou Diack, Louise Cayez, Romain Paoli-Lombardo, Édouard Lamy, Nicolas Primas, Christophe Curti, Patrice Vanelle, Pascal Rathelot

{"title":"[Training healthcare teams of a multi-site university hospital on high-alert medication issues: Using an escape room].","authors":"Pierre Leroux, Caroline Castera-Ducros, Laurence Conreur, Said Ait Taleb, Adja Fatou Diack, Louise Cayez, Romain Paoli-Lombardo, Édouard Lamy, Nicolas Primas, Christophe Curti, Patrice Vanelle, Pascal Rathelot","doi":"10.1016/j.pharma.2025.02.006","DOIUrl":"10.1016/j.pharma.2025.02.006","url":null,"abstract":"Objectives: High-Alert Medications represent a significant concern in clinical practice. The importance of raising awareness and training healthcare professionals appears essential for improving the quality and safety of care. Thus, an interactive and participatory educational format named escape room was employed in a multi-site University Hospital Center.Methods: The escape room 'Never Events Enigma' was implemented across 4 hospitals. Collaboration between our department and quality unit of each hospital facilitated the determination of organizational modalities regarding registration and session scheduling, which were carried out by our mobile team. Each session included: initial knowledge assessment, gameplay, formative debriefing and satisfaction survey. Two months later, a follow-up knowledge assessment was conducted.Results: The completion of 83 sessions enabled the training of 495 participants (average of 6 per team; minimum 2 and maximum 13). The average duration of a session was 1hour. The initial knowledge assessment revealed gaps among the various represented professions (average score 11.8/20). The satisfaction survey highlighted the relevance of this educational format. The post-training knowledge assessment demonstrated an improvement in the average score (17.2/20, gain of +5.4 points), but also its limitations, with a low response rate (25.7%).Conclusion: The escape room proved effective for the desired pedagogical objectives. This playful format offers numerous advantages to engage a diverse audience, although it represents a time-consuming method for large-scale training in small groups and requires thorough organization and communication beforehand for the smooth running of sessions.","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143522571","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}

引用次数: 0

Sommaire / Contents

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Annales pharmaceutiques francaises Pub Date : 2025-02-16 DOI: 10.1016/S0003-4509(25)00024-0

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