Annales pharmaceutiques francaises最新文献

{"title":"Companion diagnostic: An overview of regulatory framework, challenges, and future directions","authors":"Harshada Kadam, Amisha Vora, Sanjay Sharma","doi":"10.1016/j.pharma.2025.11.010","DOIUrl":"10.1016/j.pharma.2025.11.010","url":null,"abstract":"<div><div>In era of precision medicine, companion diagnostic (CDx) is prominent tool that links the gaps between diagnostics and therapeutics based on biomarker identification which helps to ensure which patient is more likely to benefit for specific treatment. Initially, the focus is on oncology treatment but in recent years the scope of CDx is gradually strengthening towards cardiology, neurology, infectious diseases and rare disorders. This review highlights the co-development of CDx with analyzation of regulatory framework in Unites State (US), Europe (EU) and in Japan. Despite of regulatory standards, there are still bottlenecks exist due to variations in approval pathways, CDx classification, technology transfer and economic issues remains major hurdle for clinical implementation. Integration of advanced technologies like Next Generation Sequencing (NGS), liquid biopsy reshaping the existing frameworks of CDx and helps to tackle existing issues. AI (Artificial Intelligence) in CDx further holds the potential to expedite the biomarker discovery which helps in designing clinical trials studies, improves patient access and provide real time monitoring of treatment response. In addition to this AI driven technologies can able to expedite regulatory decision-making process by evaluating vast, complex data sets in short period of time that ultimately enhance adaptability of CDx development. Overall, these combination of technologies focus on evolution of CDx across the regions to expand the precision medicine approach.</div></div><div><div>À l’ère de la médecine de précision, les diagnostics de compagnon (CDx) constituent un outil essentiel qui comble le fossé entre le diagnostic et le traitement, grâce à l’identification de biomarqueurs permettant de déterminer quels patients sont les plus susceptibles de bénéficier d’un traitement spécifique. Initialement axés sur le traitement oncologique, les CDx se sont progressivement étendus aux domaines de la cardiologie, de la neurologie, des maladies infectieuses et des maladies rares. Ce document passe en revue le développement des CDx et analyse le cadre réglementaire aux États-Unis, en Europe et au Japon. Malgré ces normes réglementaires, des obstacles persistent, notamment en raison des divergences des procédures d’approbation, de la classification des CDx, du transfert technologique et des problèmes économiques, qui entravent encore leur mise en œuvre clinique. L’intégration de technologies de pointe, telles que le séquençage de nouvelle génération (NGS) et les biopsies liquides, modifie le cadre actuel des CDx et contribue à résoudre ces problèmes. L’intelligence artificielle (IA) dans le domaine des CDx accélère la découverte de biomarqueurs, ce qui facilite la conception des essais cliniques, améliore l’accès aux soins et permet un suivi en temps réel de la réponse au traitement. De plus, les technologies basées sur l’IA accélèrent le processus de décision réglementaire en analysant rapidement d","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"84 2","pages":"Pages 149-160"},"PeriodicalIF":1.1,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145656683","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":"In-Vivo and In-Silico analysis of Ficus carica-based acetone extract against the DEN-induced hepatocellular carcinoma","authors":"Kiren Mustafa , Tang Qi , Sania Zaib , Hassan Khan Nasir , Karishma Marwat , Yuanda Song , Zhihe Li","doi":"10.1016/j.pharma.2025.09.004","DOIUrl":"10.1016/j.pharma.2025.09.004","url":null,"abstract":"<div><div>Hepatocellular carcinoma (HCC) is one of the most fatal cancers responsible for mortality worldwide. For the first time, a randomized controlled study was conducted on 32 Balb c albino mice to evaluate the anticancer potential of the acetone-based extract of <em>F.</em> <em>carica</em> variety from Shandong province of China. Diethylamine nitrosamine (DEN) and carbon tetrachloride (CCl<sub>4</sub>) were used as inducers of hepatic carcinoma in mice. We conducted an in vivo study on <em>F.</em> <em>carica-</em>based acetone (FA) extract that has already been proven effective against hepatoblastoma cancer (HepG2) cell lines in our previous experiments. The FA extract (60<!--> <!-->mg/kg) significantly attenuated serum levels of liver functional biomarkers (BUN, ALT, AST, ALP) and alpha-fetoprotein (AFP) in mice. Histopathological analysis revealed that the extract promoted liver tissue regeneration, restoring near-normal hepatic architecture after 60 days of treatment. Silymarin (50<!--> <!-->mg/kg), used as a positive control, similarly reduced liver injury biomarkers. Notably, the extract demonstrated comparable efficacy to silymarin, with significant reductions in serum BUN and AST levels. Complementing our in vivo results, in silico molecular docking and ADMET profiling revealed FA-derived phytochemicals (e.g., sitosterol, quercetin, luteolin) with efficacy rivaling or exceeding silymarin. These compounds exhibited strong binding affinities to hepatocellular carcinoma targets such as EGFR, VEGFR, and MMPs, thus suggesting multi-target therapeutic potential<em>.</em> The findings suggest that sitosterol, quercetin, and luteolin show competitive binding and favorable ADMET properties, proposing them as candidates for further experimental validation. This novel extract and its isolated compounds may represent a more effective and cost-efficient alternative to conventional hepatoprotective drugs for future therapeutic applications.</div></div><div><div>Le carcinome hépatocellulaire (CHC) est l’un des cancers les plus mortels au monde. Pour la première fois, une étude contrôlée randomisée a été menée sur 32 souris albinos Balb c afin d’évaluer le potentiel anticancéreux de l’extrait à base d’acétone de la variété F. carica provenant de la province chinoise du Shandong. La diéthylamine nitrosamine (DEN) et le tétrachlorure de carbone (CCl4) ont été utilisés comme inducteurs de carcinome hépatique chez les souris. Nous avons mené une étude in vivo sur l’extrait d’acétone à base de F. carica (FA) qui s’est déjà révélé efficace contre les lignées cellulaires du cancer de l’hépatoblastome (HepG2) dans nos expériences précédentes. L’extrait FA (60<!--> <!-->mg/kg) a considérablement atténué les taux sériques des biomarqueurs fonctionnels du foie (BUN, ALT, AST, ALP) et de l’alpha-fœtoprotéine (AFP) chez les souris. L’analyse histopathologique a révélé que l’extrait favorisait la régénération des tissus hépatiques, rétablissant une architecture h","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"84 2","pages":"Pages 212-226"},"PeriodicalIF":1.1,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145093482","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":"Cilianthaxone, a novel compound isolated from ethanolic extract of Ephedra ciliata and exploring its anti-inflammatory potential through in vitro, in vivo, and in silico studies","authors":"Malik Saadullah , Abid Mahmood , M. Fakhar-e-Alam , Asad Ali , Rubab Saher , Muhammad Asif","doi":"10.1016/j.pharma.2025.09.005","DOIUrl":"10.1016/j.pharma.2025.09.005","url":null,"abstract":"<div><div>The current study was designed to determine the anti-inflammatory potential of a novel compound isolated from ethanolic extract of <em>Ephedra ciliata</em> (ECE). The extract was fractionated and purified using various chromatographic techniques, followed by structural elucidation via spectroscopic methods. ECE and isolated compound cilianthaxone (ECE-2e-4) were analysed for acute toxicity by in vivo study for 14<!--> <!-->days and it was found that a dose of 2000<!--> <!-->mg/kg has no significant changes on animal body normal parameters. In vivo, animal studies like a hot plate and acetic acid-induced writhing methods were applied to determine the analgesic potential of both the ECE and cilianthaxone. In the hot plate, carrageenan-induced paw edema model, the cilianthaxone exhibited greater anti-inflammatory potential at a dose of up to 10<!--> <!-->mg/kg compared to the standard drug indomethacin. Cilianthaxone exhibited 85.35% inhibition compared to indomethacin, which showed 77.61% inhibition. The analgesic activity of the isolated compound was also confirmed by the acetic acid-indsuced writhing method, where cilianthaxone exhibited a delayed latency time of 30.50<!--> <!-->min, comparable to the standard drug morphine. Antioxidant properties of cilianthaxone were also confirmed through DPPH and NO scavenging methods and have IC<sub>50</sub> values of 14.28<!--> <!-->±<!--> <!-->0.43<!--> <!-->μg/kg and 15.60<!--> <!-->±<!--> <!-->0.21<!--> <!-->μg/kg, respectively. The chorioallantoic membrane (CAM) assay was also performed to check anti-angiogenesis, and no angio-toxicity was found. Furthermore, in silico studies were also performed to determine the binding mode and protein targeting ability of isolated compound. Overall, the current research highlights the significant anti-inflammatory effects and wound-healing potential of cilianthaxone, supported by its favorable target protein interactions.</div></div><div><div>La présente étude visait à déterminer le potentiel anti-inflammatoire d’un nouveau composé isolé à partir d’un extrait éthanolique d’<em>Ephedra ciliata</em> (ECE). L’extrait a été fractionné et purifié à l’aide de diverses techniques chromatographiques. Les fractions purifiées ont été soumises à une élucidation structurelle à l’aide de différentes techniques spectroscopiques. L’ECE et le composé isolé cilianthaxone (ECE-2e-4) ont été analysés pour déterminer leur toxicité aiguë dans le cadre d’une étude in vivo menée pendant 14 jours. Il a été constaté qu’une dose de 2000<!--> <!-->mg/kg n’entraînait aucun changement significatif des paramètres normaux du corps des animaux. In vivo, des études animales telles que la méthode de la plaque chauffante et la méthode des contorsions induites par l’acide acétique ont été utilisées pour déterminer le potentiel analgésique de l’ECE et de la cilianthaxone. Dans le modèle de plaque chauffante et d’œdème de la patte induit par le carraghénane, la cilianthaxone a montré un potenti","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"84 2","pages":"Pages 227-239"},"PeriodicalIF":1.1,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145093483","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":"Ensuring data integrity in the pharmaceutical lifecycle: Challenges, principles, and global implications","authors":"Monali Rushi Dakhole ,&nbsp;Kalyani Ramprasad Thombre ,&nbsp;Krishna Radheshyam Gupta ,&nbsp;Milind Janrao Umekar","doi":"10.1016/j.pharma.2025.10.002","DOIUrl":"10.1016/j.pharma.2025.10.002","url":null,"abstract":"<div><div>Data integrity is a cornerstone of the pharmaceutical sector's capacity to provide safe, efficacious, and high-quality medicinal products. It guarantees that data remains accurate, consistent, comprehensive, and dependable across the entire product lifecycle, encompassing research, clinical development, manufacturing, regulatory submissions, and post-marketing surveillance. This discourse explains the significance of data integrity in maintaining regulatory adherence, safeguarding patient welfare, and upholding quality benchmarks. It delves into the principles of ALCOA and ALCOA+, underscores the critical nature of Good Documentation Practices (GDP), and identifies prevalent threats such as data falsification, inadequate documentation, and insufficient system controls. Empirical case studies exemplify the grave repercussions of data breaches, alongside the advantages of robust data governance frameworks. The review further accentuates how compromised data can culminate in hazardous products and erosion of public confidence. Ultimately, it proposes methodologies for bolstering data integrity, fostering a culture of transparency, and ensuring regulatory conformity to facilitate consistent and reliable pharmaceutical operations globally.</div></div><div><div>L’intégrité des données est essentielle à la capacité du secteur pharmaceutique à fournir des médicaments sûrs, efficaces et de haute qualité. Elle garantit l’exactitude, la cohérence, l’exhaustivité et la fiabilité des données tout au long du cycle de vie du produit, incluant la recherche, le développement clinique, la fabrication, les soumissions réglementaires et la surveillance post-commercialisation. Ce document explique l’importance de l’intégrité des données pour le respect de la réglementation, la protection du bien-être des patients et le respect des normes de qualité. Il approfondit les principes d’ALCOA et d’ALCOA+, souligne l’importance des bonnes pratiques de documentation (BPD) et identifie les menaces courantes telles que la falsification des données, une documentation inadéquate et des contrôles système insuffisants. Des études de cas empiriques illustrent les graves répercussions des violations de données, ainsi que les avantages de cadres de gouvernance des données robustes. L’analyse met également en évidence comment la compromission des données peut aboutir à des produits dangereux et à une érosion de la confiance du public. En fin de compte, il propose des méthodologies pour renforcer l’intégrité des données, favoriser une culture de transparence et garantir la conformité réglementaire afin de faciliter des operations pharmaceutiques cohérentes et fiables à l’échelle mondiale.</div></div>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"84 2","pages":"Pages 175-191"},"PeriodicalIF":1.1,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145260502","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":"AI in ethnopharmacology, the pharmaceutical industry, and its applications","authors":"Ravikiran Maheshrao Suryawanshi ,&nbsp;Pratik Deepak Chaudhari ,&nbsp;Ritu M. Gilhotra","doi":"10.1016/j.pharma.2025.11.011","DOIUrl":"10.1016/j.pharma.2025.11.011","url":null,"abstract":"&lt;div&gt;&lt;div&gt;Traditional knowledge from medicinal plants receives substantial analysis through the field of ethnopharmacology in its role for drug discovery. AI technology now enhances ethnopharmacology practices through its sophisticated applications in data mining analysis combined with molecular docking systems and bioactivity prediction modeling and clinical validation processes. A review provides insights into how contemporary medicine uses artificial intelligence through machine learning, deep learning, and natural language processing to upgrade drug research while also strengthening pharmacovigilance. Advanced algorithms built around artificial intelligence analyze immense ethnobotanical records to produce predictions about biological agents along with herbal mixtures evaluation while improving quality measures in traditional medicine practices. The implementation of AI technologies allows scientists to conduct omics-based research, including genomic research and metabolic and proteomic studies, to identify pharmaceutical compounds from medicinal plants. AI plays a dual role in sustainability by supporting biodiversity conservation and respecting ethical boundaries when protecting traditional knowledge as per the study findings. The incorporation of AI technology into ethnopharmacology shows promising potential for developing evidence-based herbal medicine even though standardization and validation tasks and regulatory frameworks require improvement. Modern pharmaceutical sciences will benefit from AI-powered databases, automated clinical trials, and AI-driven drug repurposing structures to unite traditional knowledge with contemporary pharmaceutical sciences.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;div&gt;Les connaissances traditionnelles issues des plantes médicinales font l’objet d’analyses approfondies en ethnopharmacologie, notamment en ce qui concerne leur rôle dans la découverte de médicaments. L’IA améliore désormais les pratiques ethnopharmacologiques grâce à ses applications sophistiquées en matière d’analyse de données, combinées à des systèmes d’ancrage moléculaire, à la modélisation de la prédiction de la bioactivité et aux processus de validation clinique. Une analyse offre un aperçu de la manière dont la médecine contemporaine utilise l’intelligence artificielle (IA) par le biais de l’apprentissage automatique, de l’apprentissage profond et du traitement du langage naturel pour optimiser la recherche sur les médicaments et renforcer la pharmacovigilance. Des algorithmes avancés, basés sur l’IA, analysent d’immenses archives ethnobotaniques afin de produire des prédictions sur les composés bioactifs et d’évaluer les mélanges de plantes, tout en améliorant les mesures de qualité dans les pratiques de médecine traditionnelle. La mise en œuvre des technologies d’IA permet aux scientifiques de mener des recherches basées sur les sciences omiques, notamment la recherche génomique et les études métaboliques et protéomiques, afin d’identifier les composés pharm","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"84 2","pages":"Pages 161-174"},"PeriodicalIF":1.1,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145673503","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":"Characterization of thromboembolic events after recombinant coagulation factor VIIa (rFVIIa - NovoSeven®) use in cardiac surgery: A descriptive pilot study","authors":"Delphine Boden ,&nbsp;Camille Bouchand ,&nbsp;Charlotte Fenat ,&nbsp;Alison Leichnam ,&nbsp;Charles-Henri David ,&nbsp;Jean-Christophe Rigal ,&nbsp;Marion Bonsergent","doi":"10.1016/j.pharma.2025.10.004","DOIUrl":"10.1016/j.pharma.2025.10.004","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Objectives&lt;/h3&gt;&lt;div&gt;Cardiac surgery carries a high risk of bleeding. In the event of massive bleeding, the administration of rFVIIa may be necessary. However, due to the thromboembolic risk, the use of this factor is only recommended for severe bleeding that does not respond to standard treatments. Our aim was to describe the use of rFVIIa in bleeding situations in cardiac surgery and the thromboembolic events after administration.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;This is a monocentric observational study including patients who received rFVIIa from January 2019 to December 2021 for the treatment of massive bleeding associated with cardiac surgery. Data collected included population characteristics, surgery, bleeding management, rFVIIa prescription and incidence of postoperative thromboembolic events.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;A total of 67 patients were included. Most of the operations were for aortic dissection (46%) and valve replacement (33%), and 54% of the cases were urgent procedures. Labile blood products were systematically used in the treatment of bleeding. The average total dose of rFVIIa per patient was 10&lt;!--&gt; &lt;!--&gt;±&lt;!--&gt; &lt;!--&gt;5&lt;!--&gt; &lt;!--&gt;mg, i.e. an average total dose/weight of 129&lt;!--&gt; &lt;!--&gt;±&lt;!--&gt; &lt;!--&gt;67&lt;!--&gt; &lt;!--&gt;μg/kg. Postoperative thromboembolic events occurred in 22 patients (33%), in 73% of cases in the superior vena cava (head, neck and upper extremities).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusions&lt;/h3&gt;&lt;div&gt;Our study allowed us to describe the use of rFVIIa in massive bleeding in cardiac surgery. The average total dose of rFVIIa administered was higher in patients with thromboembolic events than in those who did not. A more robust study will be conducted to investigate the attributability of rFVIIa to the occurrence of postoperative thromboembolic events.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Objectifs&lt;/h3&gt;&lt;div&gt;Les chirurgies cardiaques sont à haut risque de saignement. En cas d’hémorragie massive, l’administration de rFVIIa peut être nécessaire. Cependant, dû au risque thromboembolique, l’utilisation de ce facteur est uniquement recommandée en cas de saignements sévères réfractaires aux traitements standards. Notre objectif était de décrire l’utilisation du rFVIIa dans les hémorragies massives de chirurgie cardiaque et la survenue associée d’événements thromboemboliques.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Méthodes&lt;/h3&gt;&lt;div&gt;Il s’agit d’une étude monocentrique observationnelle incluant les patients ayant reçu du rFVIIa entre janvier 2019 et décembre 2021 pour le traitement d’une hémorragie massive liée à une chirurgie cardiaque. Les données collectées concernaient les patients, la chirurgie, la gestion du saignement, la prescription du rFVIIa et l’incidence des événements thromboemboliques post-opératoires.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Résultats&lt;/h3&gt;&lt;div&gt;Au total, 67 patients ont été inclus. Les principales interventions étaient des dissections aortiques (46 %) et des remplacements valvulaires (33 %), et 54 % des opérations étaient urgentes. L’utilisatio","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"84 2","pages":"Pages 240-249"},"PeriodicalIF":1.1,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145277060","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":"Comparative evaluation of the anticancer effects of Echium amoenum and Valeriana officinalis on U87-MG glioblastoma cells","authors":"Maryam Mohseni ,&nbsp;Reza Masoomi Jahandizi ,&nbsp;Ehsan Zayerzadeh","doi":"10.1016/j.pharma.2025.08.003","DOIUrl":"10.1016/j.pharma.2025.08.003","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Objectives&lt;/h3&gt;&lt;div&gt;Glioblastoma (GBM) is one of the most aggressive and treatment-resistant types of brain cancer, and conventional therapies such as surgery, chemotherapy, and radiotherapy have limited effectiveness in controlling it. In this context, the use of natural compounds with anticancer properties has been explored as a complementary strategy. The purpose of the current study was to assess the cytotoxic and pro-apoptotic potential of the plant extracts &lt;em&gt;Echium amoenum&lt;/em&gt; and &lt;em&gt;Valeriana officinalis&lt;/em&gt; in U87-MG glioblastoma cells.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Materials and methods&lt;/h3&gt;&lt;div&gt;The Maceration technique was used to prepare the plant extracts. U87-MG cells and L-929 cell lines were cultured and treated with various concentrations (31.25, 62.5, 125, 250, 500 and 1000&lt;!--&gt; &lt;!--&gt;μg/mL) of the extracts upon reaching optimal confluence. An MTT assay was performed to evaluate the cytotoxicity at 24, 48 and 72&lt;!--&gt; &lt;!--&gt;hours. To investigate the expression of apoptosis-related genes (&lt;em&gt;Bax&lt;/em&gt;, &lt;em&gt;Bcl-2&lt;/em&gt; and &lt;em&gt;Caspase-3&lt;/em&gt;, &lt;em&gt;Caspase-9&lt;/em&gt; and &lt;em&gt;puma&lt;/em&gt;), RNA was extracted and converted to cDNA and then the expression of these genes was analyzed by real-time PCR.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;MTT assay results showed that both extracts inhibited cancer cell growth in a dose- and time-dependent manner. At 72&lt;!--&gt; &lt;!--&gt;hours and a concentration of 1000&lt;!--&gt; &lt;!--&gt;μg/mL, &lt;em&gt;E. amoenum&lt;/em&gt; extract exhibited the highest inhibition rate (96%), while &lt;em&gt;V. officinalis&lt;/em&gt; extract showed 95% inhibition under the same conditions. At the molecular level, &lt;em&gt;E. amoenum&lt;/em&gt; extract significantly upregulated &lt;em&gt;Caspase-3&lt;/em&gt; expression by more than 20-fold (&lt;em&gt;P&lt;/em&gt; &lt;!--&gt;&lt;&lt;!--&gt; &lt;!--&gt;0.0001) indicating a strong activation of the apoptotic pathway, while &lt;em&gt;V. officinalis&lt;/em&gt; extract did not cause a significant change in the expression of this gene. Additionally, &lt;em&gt;Bcl-2&lt;/em&gt; expression was significantly elevated in the &lt;em&gt;E. amoenum&lt;/em&gt;-treated group (&lt;em&gt;P&lt;/em&gt; &lt;!--&gt;&lt;&lt;!--&gt; &lt;!--&gt;0.001). However, the upregulation of &lt;em&gt;Bcl-2&lt;/em&gt;—a gene associated with cell survival—was considerably weaker compared to the robust induction of &lt;em&gt;Caspase-3&lt;/em&gt;. Also, &lt;em&gt;E. amoenum&lt;/em&gt; significantly upregulated &lt;em&gt;Caspase-9&lt;/em&gt; expression (&lt;em&gt;P&lt;/em&gt; &lt;!--&gt;&lt;&lt;!--&gt; &lt;!--&gt;0.0001), indicating activation of the intrinsic apoptotic pathway.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;The results demonstrated that extracts from &lt;em&gt;V. officinalis&lt;/em&gt; and &lt;em&gt;E. amoenum&lt;/em&gt; have anticancer effects on U87-MG cells, possibly through the induction of apoptosis. &lt;em&gt;E. amoenum&lt;/em&gt; was more effective in raising &lt;em&gt;Caspase-3&lt;/em&gt; and initiating pathways leading to programmed cell death, whereas &lt;em&gt;V. officinalis&lt;/em&gt; did not change the expression levels of apoptotic genes. Our finding suggests that this plant may exert its anticancer effects through non-apoptotic or alternative apoptotic mechanisms, rather than the c","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"84 1","pages":"Pages 90-100"},"PeriodicalIF":1.1,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803311","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":"Synthesizing safety data on novel intravaginal formulations: A comprehensive scoping review of in vivo and in vitro research","authors":"Athul TP ,&nbsp;Anjani Seth ,&nbsp;Vanshika Sharma ,&nbsp;Meenakshi Pandey ,&nbsp;R. Galib ,&nbsp;Sanjay Jachak ,&nbsp;Tanuja Nesari ,&nbsp;Meena S. Deogade","doi":"10.1016/j.pharma.2025.07.009","DOIUrl":"10.1016/j.pharma.2025.07.009","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Background and objectives&lt;/h3&gt;&lt;div&gt;Intravaginal drug delivery systems are gaining attention for their potential to treat local and systemic gynaecological conditions, offering advantages such as bypassing hepatic first-pass metabolism and improved bioavailability. However, the safety evaluation of these novel formulations remains inconsistent, with limited regulatory guidance. This scoping review aims to consolidate data from in vivo and in vitro safety studies to support the design of standardized safety protocols for future intravaginal formulations.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Materials and methods&lt;/h3&gt;&lt;div&gt;A systematic data search was conducted using PubMed and Scopus (2009–2024) data base following PRISMA-ScR guidelines. Eligible studies were included after data screening by individual reviewers. Study selection, data extraction, and charting were performed using a pre-defined protocol registered on the Open Science Framework.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;A total of 77 studies were included, comprising 64 in vivo and 13 in vitro studies. Rabbit was the frequently used animal model, while HeLa and normal vaginal epithelial cells were predominant in cell-based assays. Key safety endpoints evaluated included vaginal irritation, systemic toxicity, cytotoxicity, and cytokine expression. A wide range of formulations was assessed, including gels, rings, suppositories, and hydrogels.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusions&lt;/h3&gt;&lt;div&gt;This review highlights the need for harmonized safety assessment protocols for intravaginal formulations. By mapping current practices and models used in preclinical research, this work offers a foundation for researchers and regulators to develop more robust and standardized safety evaluation frameworks.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Contexte et objectifs&lt;/h3&gt;&lt;div&gt;Les systèmes d’administration intravaginale de médicaments suscitent un intérêt croissant pour leur potentiel dans le traitement des affections gynécologiques locales et systémiques, offrant des avantages tels que le contournement du métabolisme de premier passage hépatique et une biodisponibilité améliorée. Cependant, l’évaluation de la sécurité de ces nouvelles formulations reste incohérente, les directives réglementaires étant limitées. Cette revue de la littérature vise à consolider les données issues d’études de sécurité in vivo et in vitro afin de soutenir la conception de protocoles de sécurité standardisés pour les futures formulations intravaginales.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Matériel et méthodes&lt;/h3&gt;&lt;div&gt;Une recherche systématique de données a été réalisée à l’aide des bases de données PubMed et Scopus (2009–2024) conformément aux recommandations PRISMA-ScR. Les études éligibles ont été incluses après examen des données par des évaluateurs individuels. La sélection des études, l’extraction des données et la consignation des données ont été réalisées selon un protocole prédéfini et enregistré dans l’Open Science Framework.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Résultats&lt;/h3&gt;&lt;div&gt;Au to","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"84 1","pages":"Pages 35-47"},"PeriodicalIF":1.1,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144717278","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":"Laggera pterodonta: Traditional uses, phytochemistry and biological activities","authors":"Pham Van Huyen,&nbsp;Nguyen Thi Thu Hien,&nbsp;Tran Thi Ngoc Hanh,&nbsp;Nguyen Huu Huong Duyen,&nbsp;Nguyen Huu Toan Phan,&nbsp;Nguyen Thi Dieu Thuan","doi":"10.1016/j.pharma.2025.07.008","DOIUrl":"10.1016/j.pharma.2025.07.008","url":null,"abstract":"<div><div><em>Laggera pterodonta</em> is a promising medicinal plant with multiple therapeutic applications, supporting its traditional use and potential for modern drug development. With its diverse bioactive constituents such as flavonoids, terpenoids, phenolics, alkaloids, and lignans, along with antiviral activity, anti-inflammatory activity, insecticidal activity, antibacterial activity, and antifungal activity, <em>L. pterodonta</em> is gradually asserting its value in pharmaceutical applications. Studies have shown its effectiveness against influenza viruses, enteroviruses, and herpes simplex viruses by inhibiting viral replication and modulating immune responses. Additionally, its anti-inflammatory effects help reduce pro-inflammatory cytokines, while its antimicrobial and antifungal activities make it a promising candidate for combating drug-resistant pathogens. The plant's insecticidal properties suggest its potential use in eco-friendly pest control. The present review aims to provide an in-depth report on the traditional uses, phytochemistry, and biological activities of <em>L. pterodonta</em>. This knowledge provides scientists with a clear direction for effectively utilizing the plant in the search for potent and sustainable medicinal resources for public health care.</div></div><div><div><em>Laggera pterodonta</em> est une plante médicinale prometteuse présentant de multiples applications thérapeutiques, ce qui soutient son usage traditionnel ainsi que son potentiel pour le développement pharmaceutique moderne. Grâce à sa richesse en composés bioactifs divers tels que les flavonoïdes, les terpènes, les composés phénoliques, les alcaloïdes et les lignanes, et à ses activités antivirale, anti-inflammatoire, insecticide, antibactérienne et antifongique, <em>L. pterodonta</em> affirme progressivement sa valeur dans les applications pharmaceutiques. Des études ont démontré son efficacité contre les virus de la grippe, les entérovirus et les virus de l’herpès simplex, en inhibant la réplication virale et en modulant les réponses immunitaires. En outre, ses effets anti-inflammatoires contribuent à réduire les cytokines pro-inflammatoires, tandis que ses activités antimicrobienne et antifongique en font une candidate prometteuse dans la lutte contre les agents pathogènes résistants aux médicaments. Les propriétés insecticides de la plante suggèrent également un potentiel dans le cadre de la lutte antiparasitaire respectueuse de l’environnement. La présente revue vise à fournir un rapport approfondi sur les usages traditionnels, la phytochimie et les activités biologiques de <em>L. pterodonta</em>. Ces connaissances offrent aux scientifiques une orientation claire pour exploiter efficacement cette plante dans la recherche de ressources médicinales puissantes et durables en faveur de la santé publique.</div></div>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"84 1","pages":"Pages 1-34"},"PeriodicalIF":1.1,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144681911","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 evolving role of Hospital Oncology Pharmacists (HOPs) in assessing therapeutic innovations and managing toxicities in cancer care","authors":"Florence Ranchon ,&nbsp;Florian Slimano ,&nbsp;Maha Ayyoub ,&nbsp;Charlotte Bérard ,&nbsp;Anais Grand ,&nbsp;Marie Kroemer ,&nbsp;Xavier Paoletti ,&nbsp;Vérane Schwiertz ,&nbsp;Pascale Tomasini ,&nbsp;Christophe Bardin ,&nbsp;Emmanuel Raffoux ,&nbsp;Catherine Rioufol ,&nbsp;Régine Chevrier ,&nbsp;Bertrand Pourroy ,&nbsp;Jean-Louis Cazin","doi":"10.1016/j.pharma.2025.10.001","DOIUrl":"10.1016/j.pharma.2025.10.001","url":null,"abstract":"<div><div>Hospital oncology pharmacy (HOP) is evolving in tandem with the rapid pace of oncology research, encompassing breakthroughs in anticancer therapies, the management of treatment-related toxicities, and the application of novel methodologies for evaluating therapeutic strategies. This paper presents a synthesis on these topics, based in part, on the latest scientific event organized by the French society for oncology pharmacy (SFPO), known as St. Louis’ Day. During this event, seven leading experts — comprising medical oncologists and HOPs — engaged in in-depth discussions on three pivotal themes: the assessment of therapeutic innovations, recent progress in cancer-related vaccinology, and the management of immune-related adverse events. The proceedings underscore the critical role of HOPs as key members of the interdisciplinary oncology team, driving ongoing advancements in the quality and safety of cancer care.</div></div><div><div>Le pharmacien hospitalier en oncologie est pleinement intégré au rythme rapide des évolutions de la recherche, englobant les progrès thérapeutiques, la prise en charge des toxicités liées aux traitements anticancéreux et la mise en place de nouvelles méthodologies d’évaluation des stratégies thérapeutiques. Cet article présente une synthèse de ces sujets basée, en partie, sur le dernier évènement scientifique organisé par la Société française de pharmacie oncologique (SFPO), « La journée de Saint Louis ». Durant cet évènement, sept experts de premier plan – oncologues médicaux et pharmaciens hospitaliers en oncologie – ont engagé des discussions sur trois thèmes pivots : évaluation des innovations thérapeutiques, vaccinologie anticancéreuse et toxicités des immunothérapies. Les débats ont pointé le rôle essentiel des pharmaciens hospitaliers en oncologie en tant que membres des équipes interdisciplinaires conduisant les progrès continus dans la qualité et la sécurité de la prise en charge du malade présentant un cancer.</div></div>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"84 1","pages":"Pages 69-77"},"PeriodicalIF":1.1,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145277107","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}