Articles publiés en 2023
- What place for intelligent automation and artificial intelligence to preserve and strengthen vigilance expertise in the face of increasing declarations ?
Pariente A., Micallef J., Lahouegue A., Molimard M., Auffret M., Chouchana L., Denis B., Faillie J.L., Grandvuillemin A., Letinier L., Pierron E., Pons C., Pujade I., Rubino H., Salvo F.
Therapies. 78(1) (pp 131-143), 2023. Date of Publication: 01 Jan 2023. - Patient involvement in pharmacovigilance: determinants and evolution of reporting from 2011 to 2020 in France.
Adopo D., Daynes P., Benkebil M., Debs A., Jonville-Berra A., Polard E., Micallef J., Maison P.
European Journal of Clinical Pharmacology. 79(2) (pp 229-236), 2023. Date of Publication: February 2023. - Estimation of the influenza-associated respiratory hospitalization burden using sentinel surveillance data, Lebanon, 2015-2020.
Farah Z., El Naja H.A., Tempia S., Saleh N., Abubakar A., Maison P., Ghosn N.
Influenza and other Respiratory Viruses. 17(4) (no pagination), 2023. Article Number: e13138. Date of Publication: April 2023. - Patient and public involvement in the benefit-risk assessment and decision concerning health products: Position of the Scientific Advisory Board of the French National Agency for Medicines and Health Products Safety (ANSM).
Belgodere L., Pougheon Bertrand D., Jaulent M.C., Rabeharisoa V., Janssens W., Rollason V., Barbot J., Vernant J.P., Oualikene Gonin W., Maison P., Ankri J.
BMJ Global Health. 8(5) (no pagination), 2023. Article Number: e011966. Date of Publication: 19 May 2023. - Prevalence of medication administration errors in hospitalized adults: A systematic review and meta-analysis up to 2017 to explore sources of heterogeneity.
Azar C., Raffoul P., Rizk R., Boutros C., Saleh N., Maison P.
Fundamental and Clinical Pharmacology. 37(3) (pp 531-548), 2023. Date of Publication: June 2023. - Use of proton pump inhibitors during pregnancy: A systematic review and meta-analysis of congenital malformations.
Peron A., Ripoche E., Picot C., Ajiji P., Cucherat M., Cottin J.
Reproductive Toxicology. 119 (no pagination), 2023. Article Number: 108419. Date of Publication: August 2023. - Arboviral Risk Associated with Solid Organ and Hematopoietic Stem Cell Grafts: The Prophylactic Answers Proposed by the French High Council of Public Health in a National Context.
Pozzetto B., Grard G., Durand G., Paty M.-C., Gallian P., Lucas-Samuel S., Dieterle S., Fromage M., Durand M., Lepelletier D., Chidiac C., Hoen B., Nicolas de Lamballerie X.
Viruses. 15(9) (no pagination), 2023. Article Number: 1783. Date of Publication: September 2023. - An academia-driven compassionate use program for patients with recurrent H3K27-altered diffuse midline glioma: a new way to access innovation when clinical trials are lacking.
Di Carlo D., Annereau M., Yoldjian I., Vassal G., Grill J.
Annals of Oncology. 34(9) (pp 826-827), 2023. Date of Publication: September 2023. - National reflection on organs-on-chip for drug development: New regulatory challenges.
Teixeira SG, Houeto P, Gattacceca F, Petitcollot N, Debruyne D, Guerbet M, Guillemain J, Fabre I, Louin G, Salomon V
Toxicology Letters. 388:1-12, 2023 Sep 28. - Access to innovation through clinical trials and the national early access program for patients with lung cancer in France: focus on atezolizumab and durvalumab.
Jacquet E., Pham F., Taouk B., Kerouani-Lafaye G., Monard A., Brunel L., Albin N.
Cancer Chemotherapy and Pharmacology. 92(3) (pp 223-228), 2023. Date of Publication: September 2023. - Opposed evolution of the osseous and soft parts of progestin-associated osteomeningioma after progestin intake discontinuation.
Florea SM, Passeri T, Abbritti R, Bernat AL, Fontanel S, Yoldjian I, Funck-Brentano T, Weill A, Mandonnet E, Froelich S
Journal of Neurosurgery. 139(4):944-952, 2023 Oct 01. - Performance Characteristics of Mass Spectrometry-Based Analytical Procedures for Quantitation of Nitrosamines in Pharmaceuticals: Insights from an Inter-laboratory Study.
Yang J., Kakarla R., Marzan T., Sherwin B., George M., Bennett J., Basutto J., Su Y., Ollerenshaw J., Morin J., Rebiere H., Maggio A.-F., Kermaidic A., Gervela E., Brenier C., Civade C., Chauvey D., Duperray F., Wollein U., Conti M., Tromp J., Meyer S., Wanko R., Wierer M., Bertrand M., Rodriguez J., Sommers C., Keire D.
Journal of Pharmaceutical Sciences. 112(10) (pp 2685-2695), 2023. Date of Publication: October 2023. - Real-world dostarlimab use in advanced/recurrent endometrial cancer in France.
Rodrigues M., Eberst L., Follana P., Gauthier L., Jacquemin V., Tessier C., El Mouaddin N., Boudier P., Fiteni F., Angeli E., Roche S., Delanoy N., Sabatier R., Flippot R., de la Motte Rouge T.
Bulletin du Cancer. 110(10) (pp 1041-1050), 2023. Date of Publication: October 2023. - Assessment of 19 years of a prospective national survey on drug-facilitated crimes in France.
Djezzar S., Gaulier J.-M., Gorgiard C., Cheze M., Alvarez J.-C., Martin C., Dumestre-Toulet V., Lavit M., Mathieu O., Eysseric H., Berland E., Roussel C., Gaillard Y., Hurtel-Lemaire A.-S., Deveaux M., Pion C.
Legal Medicine. 65 (no pagination), 2023. Article Number: 102297. Date of Publication: November 2023. - S14-3 Effets indesirables receveurs (EIR) apres transfusion de plaquettes (CP) 2007-2021.
Andreu G., Carlier M., Drouet C., Mertes P.-M., Py J.-Y., Ambroise Tacquard C., Boudjedir K.
Transfusion Clinique et Biologique. Conference: SFTS 2023. Toulouse France. 30(Supplement 1) (pp S15), 2023. Date of Publication: November 2023. - L08-4 Presentation de l'hemovigilance en France et focus sur le TACO.
Boudjedir K., Sandid I., Drougard S., Freyche C., Lenzotti A.-M., Fromage M., Matko C., Sainte Marie I.
Transfusion Clinique et Biologique. Conference: SFTS 2023. Toulouse France. 30(Supplement 1) (pp S10), 2023. Date of Publication: November 2023. - Clustering of Tadalafil API Samples According to their Manufacturer in the Context of API Falsification Detection.
Deconinck E., Raimondo M., Borioni A., Grange Y., Rebiere H., Mihailova A., Boyum O., Maurin J.K., Piorunska-Sedlak K., Olsen L.S., Acevska J., Brezovska K., Rundlof T., Portela M.J., Meieranz S., Miquel M., Bertrand M.
Journal of Pharmaceutical Sciences. 112(11) (pp 2834-2842), 2023. Date of Publication: November 2023. - The new European Medicines Agency guideline on antidepressants: a guide for researchers and drug developers.
Butlen-Ducuing F, Haberkamp M, Aislaitner G, Balkowiec-Iskra E, Mattila T, Doucet M, Kollb-Sielecka M, Balabanov P, Leuchs AK, Elferink A
European Psychiatry: the Journal of the Association of European Psychiatrists. 67(1):e2, 2023 Dec 15. - Risk of drug use during pregnancy: master protocol for living systematic reviews and meta-analyses performed in the metaPreg project.
Picot C., Ajiji P., Jurek L., Nourredine M., Massardier J., Peron A., Cucherat M., Cottin J.
Systematic Reviews. 12(1) (no pagination), 2023. Article Number: 101. Date of Publication: December 2023. - Independent control of COVID-19 vaccines by EU Official Control Authority Batch Release: challenges, strengths and successes.
Milne C., Wagner R., Cano F., Bruysters M., Waeterloos G., Pullirsch D., Wierer M., Mallet L.
npj Vaccines. 8(1) (no pagination), 2023. Article Number: 22. Date of Publication: December 2023. - Informal investigation on the added value of a potential certification system for the qualification of raw materials for the production of ATMPs.
Le Maux S., Closson-Carella V., Kolaj-Robin O., Bruguera H., Charton E.
Pharmeuropa bio & scientific notes. 2023 (pp 60-68), 2023. Date of Publication: 2023. - Alprazolam misuse: Analysis of French Addictovigilance Network data from 2011 to 2020.
Diaz L., Eiden C., Jouanjus E., Frauger E., Fouilhe N., Djezzar S., Gibaja V., Boucher A., Le Boisselier R., Libert F., Caous A.-S., Monzon E., Guerlais M., Daveluy A., Fauconneau B., Peyriere H.
Therapies. (no pagination), 2023. Date of Publication: 2023. - Validation of a qPCR method for determination of viral genome titres of AAV2-based vector preparations.
Ridoux V, Laurens S, Venturini S, Le Tallec D, Costanzo A
Pharmeuropa bio & scientific notes. 2023:42-59, 2023. - Clinical Trial Authorisation: A Final Look Back to Better Appraise the New European Regulation.
Vignot S., Guyader G., Salomon V., Vella P., Yoldjian I., Maison P., Ratignier-Carbonneil C.
Reviews on Recent Clinical Trials. 18(3) (pp 167-171), 2023. Date of Publication: 2023. - Risk of hospitalisation for serious colchicine intoxication after concomitant exposure to pristinamycin: A nationwide healthcare database study.
Souty C., Vilcu A.-M., Conte C., Saint-Salvi B., Sarazin M., Rossignol L., Blanchon T., Hanslik T., Lapeyre-Mestre M., Steichen O.
Therapies. (no pagination), 2023. Date of Publication: 2023. - Regulatory assessment of nano-enabled health products in public health interest. Position of the scientific advisory board of the French National Agency for the Safety of Medicines and Health Products.
Oualikene-Gonin W., Sautou V., Ezan E., Bastos H., Bellissant E., Belgodere L., Maison P., Ankri J.
Frontiers in public health. 11 (pp 1125577), 2023. Date of Publication: 2023. - Implementation of amotosalen plus ultraviolet A-mediated pathogen reduction for all platelet concentrates in France: Impact on the risk of transfusion-transmitted infections.
Richard P., Pouchol E., Sandid I., Aoustin L., Lefort C., Chartois A.-G., Baima A., Malard L., Bacquet C., Ferrera-Tourenc V., Gallian P., Laperche S., Bliem C., Morel P., Tiberghien P.
Vox Sanguinis. (no pagination), 2023. Date of Publication: 2023. - Prevention and management of health products shortages by the French national agency (ANSM), 10 years of experience.
Belgodere L., Emmerich J., Albin N., Bacon T., Daynes P., Vignot S., Vial T., Renaud G., Le Saulnier C., Maillard-Couvreur C., Cachet M., Veyries M.-L., Youdarene R., Oualikene-Gonin W., Ratignier-Carbonneil C., Maison P.
Frontiers in public health. 11(pp 1293110), 2023. Date of Publication: 2023. - Numerical study of the deployment of a femoral artery self-expanding nitinol stent.
Parpaillon E., Nguyen T.-H., Louche H., Huon V., Chauvey D., Jeanjean A., Jourdan F.
Computer Methods in Biomechanics and Biomedical Engineering. Conference: 48th Congress of the Society of Biomechanics. Grenoble France. 26(Supplement 1) (pp S148-S149), 2023. Date of Publication: 2023.
Articles publiés en 2022
- Edito : Reform of early access to medicinal products in France. Reforme de l'accès dérogatoire aux médicaments.
Chu C., Barbou des Courieres S., Fournier K., Kelley S., Bay J.-O., Gadeyne M.
Bulletin du Cancer. 109(1) (pp 20-22), 2022. Date of Publication: January 2022. - European fingerprint study on omeprazole drug substances using a multi analytical approach and chemometrics as a tool for the discrimination of manufacturing sources.
Rebiere H., Grange Y., Deconinck E., Courselle P., Acevska J., Brezovska K., Maurin J., Rundlof T., Portela M.J., Olsen L.S., Offerle C., Bertrand M.
Journal of Pharmaceutical and Biomedical Analysis. 208 (no pagination), 2022. Article Number: 114444. Date of Publication: 20 Jan 2022. - GEONs API fingerprint project: Selection of analytical techniques for clustering of sildenafil citrate API samples.
Deconinck E., Courselle P., Raimondo M., Grange Y., Rebiere H., Mihailova A., Boyum O., Maurin J.K., Piorunska-Sedlak K., Olsen L.S., Acevska J., Brezovska K., Rundlof T., Portela M.J., Bertrand M.
Talanta. 239 (pp 123123), 2022. Date of Publication: 01 Mar 2022 - Patterns of Medication Errors Involving Older Adults Reported to the French Medication Error Guichet.
Azar C., Thomas L., Gras-Champel V., Laroche M.-L., Grau M., Allue D., Saleh N., Maison P. Journal of patient safety. 18(2) (pp e514-e521), 2022. Date of Publication: 01 Mar 2022. - Incidence, associated factors, and effect on renal function of amoxicillin crystalluria in patients receiving high doses of intravenous amoxicillin (The CRISTAMOX Study): A cohort study.
Demotier S., Limelette A., Charmillon A., Baux E., Parent X., Mestrallet S., Pavel S., Servettaz A., Drame M., Muggeo A., Wynckel A., Gozalo C., Taam M.A., Fillion A., Jaussaud R., Trenque T., Piroth L., Bani-Sadr F., Hentzien M.
eClinicalMedicine. 45 (no pagination), 2022. Article Number: 101340. Date of Publication: March 2022. - Hypersensitivity transfusion reactions to fresh frozen plasma: a retrospective analysis of the French hemovigilance
Tacquard C., Andreu G., Meyer N., Carlier M., Py J.-Y., Drouet C., Bienvenu J., Mertes P.M., Boudjedir K.
Transfusion Medicine Reviews. 36(2) (pp 77-81), 2022. Date of Publication: April 2022. - Biases associated with epidermal necrolysis reporting in pharmacovigilance: An exploratory analysis using World Health Organization VigiBase
Bettuzzi T., Ingen-Housz-Oro S., Maison P., de Prost N., Wolkenstein P., Lebrun-Vignes B., Sbidian E.
Pharmacoepidemiology and Drug Safety. 31(4) (pp 434-441), 2022. Date of Publication: April 2022. - Letter to the Editor: Added therapeutic benefit regarding ESMO-MCBS and the French health technology assessment of drugs granted early access program
Pham FY, Jacquet E, Monard A, Brunel L, Blay JY, Albin N
Annals of Oncology. 33(5):561-563, 2022 05. - Validation of Artificial Intelligence to Support the Automatic Coding of Patient Adverse Drug Reaction Reports, Using Nationwide Pharmacovigilance Data
Martin G.L., Jouganous J., Savidan R., Bellec A., Goehrs C., Benkebil M., Miremont G., Micallef J., Salvo F., Pariente A., Letinier L.
Drug Safety. 45(5) (pp 535-548), 2022. Date of Publication: May 2022. - Feasibility study and evaluation of expert opinion on the semi-automated meta-analysis and the conventional meta-analysis
Ajiji P., Cottin J., Picot C., Uzunali A., Ripoche E., Cucherat M., Maison P.
European Journal of Clinical Pharmacology. 78(7) (pp 1177-1184), 2022. Date of Publication: July 2022. - Authorization of COVID-19 clinical trials: lessons from 2 years of experience of a national competent authority
Vignot S., Dhanani A., Sainte-Marie I., de Ligniville Lajavardi L., Even G., Echemann M., Hulin N., Menoret C., Maison P., Ratignier-Carbonneil C.
Frontiers in Pharmacology. 13 (no pagination), 2022. Article Number: 972660. Date of Publication: 15 Aug 2022. - Adverse reactions following transfusion of blood components, with a focus on some rare reactions: Reports to the International Haemovigilance Network Database (ISTARE) in 2012-2016
Politis C., Wiersum-Osselton J., Richardson C., Grouzi E., Sandid I., Marano G., Goto N., Condeco J., Boudjedir K., Asariotou M., Politi L., Land K.
Transfusion Clinique et Biologique. 29(3) (pp 243-249), 2022. Date of Publication: August 2022. - IT/QA and Regulatory Aspects of Digital Pathology: Results of the 8thESTP International Workshop
Boisclair J., Bawa B., Barale-Thomas E., Bertrand L., Carter J., Crossland R., Dorn C., Forest T., Grote S., Gilis A., Hildebrand D., Knight B., Laurent S., Marxfeld H.A., Ostergaard S.J., Roguet T., Schlueter T., Schumacher V., Spehar R., Varady W., Zeugin C.
Toxicologic Pathology. 50(6) (pp 793-807), 2022. Date of Publication: August 2022. - L'Histoire d'une mobilisation : deux ans après !
Salomon V., Bernard C., Odou P., Pirot F.
Journal de Pharmacie Clinique. 41(3) (pp 97-98), 2022. Date of Publication: September 2022. - Adverse events of recreational cannabis use during pregnancy reported to the French Addictovigilance Network between 2011 and 2020
Bouquet E., Eiden C., Fauconneau B., Pion C., Pain S., Perault-Pochat M.-C.
Scientific reports. 12(1) (pp 16509), 2022. Date of Publication: 03 Oct 2022. - Survival, cost and added therapeutic benefit of drugs granted early access through the French temporary authorization for use program in solid tumors from 2009 to 2019Pham F.Y.V., Jacquet E., Taleb A., Monard A., Kerouani-Lafaye G., Turcry F., Brunel L., Grude F., Yoldjian I., Sainte-Marie I., Boudali L., Blay J.-Y., Albin N.
International Journal of Cancer. 151(8) (pp 1345-1354), 2022. Date of Publication: 15 Oct 2022. - Quelle place pour l'automatisation intelligente et l'intelligence artificielle pour preserver et renforcer l'expertise en vigilance devant l'augmentation des declarations ?
Pariente A, Micallef J, Lahouegue A, Molimard M, Auffret M, Chouchana L, Denis B, Faillie JL, Grandvuillemin A, Letinier L, Pierron E, Pons C, Pujade I, Rubino H, Salvo F
Therapie. 2022 Nov 25. - Pharmacovigilance for COVID-19 vaccines: A 1-year experience in France
Crommelynck S., Thill P.
Infectious Diseases Now. 52(8 Supplement) (pp S16-S18), 2022. Date of Publication: November 2022. - Patient involvement in pharmacovigilance: determinants and evolution of reporting from 2011 to 2020 in FranceAdopo D, Daynes P, Benkebil M, Debs A, Jonville-Berra AP, Polard E, Micallef J, Maison P
European Journal of Clinical Pharmacology. 2022 Dec 12. - European regulatory strategy for supporting childhood cancer therapy developments
Karres D., Lesa G., Ligas F., Benchetrit S., Galluzzo S., Van Malderen K., Sterba J., van Dartel M., Renard M., Sisovsky P., Wang S., Norga K.
European Journal of Cancer. 177 (pp 25-29), 2022. Date of Publication: December 2022.