Articles publiés en 2025
- Using patient-reported outcomes and health-related quality of life data in regulatory decisions on cancer treatment: highlights from an EMA-EORTC workshop.
Pe M., Voltz-Girolt C., Bell J., Bhatnagar V., Bogaerts J., Booth C., Burgos J.G., Cappelleri J.C., Coens C., Demolis P., Enzmann H., Giesinger J.M., Gilbert A., Groenvold M., Kluetz P., Piccinin C., Postmus D., Quinten C., Ryll B., Sasseville M., Schlichting M., Schuerer H., Schiel A., Shaw J.W., Smith A.W., Tezuka S., Torre C., van der Graaf W.T.A., Wieseler B., Wittenbecher F., Reijneveld J.C., Mol P.
The Lancet Oncology, Volume 26, Issue 6, 687 - 690 - Concilier régulation du médicament et démocratie sanitaire : rôle des conseillers patient ou professionnel de santé à l’ANSM
Maison P., Bacon T., Daynes P., Decoene C., Mazet R., Vial T., Vignot S., Belgodere L., Oualikene-Gonin W., Ratignier-Carbonneil C.
Therapies, Volume 80, Issue 3, May–June 2025, Pages 311-317 - Cardiac serious adverse reactions in donors in France 2010-21.
Boudjedir K., Carlier M., Herve I., Mertes P.-M., Somme S., Lenzotti A.-M., Follea G.
Transfusion Clinique et Biologique, Volume 32, Issue 2, May 2025, Pages 199-204 - Tramadol During Pregnancy: Risk of Adverse Pregnancy Outcome and Major Congenital Anomalies. A Comparative Study in the EFEMERIS Database.
Ferrer E., Delteil L., Caillet A., Karam F., Lacroix I.
Pharmacoepidemiology and Drug Safety, Volume 34, Issue 4, e70143, April 2025 - Frequencies and causes of ABO-incompatible red cell transfusions in France, Germany and the United Kingdom
Mirrione-Savin A., AghiliPour H., Swarbrick N., Muller S., Bacquet C., Malard L., Murphy M.F., Richard P., Davies J., Rowley M., Poles D., Sandid I., Funk M.B., Narayan S., Tiberghien P., Schafer R.
British Journal of Haematology, Volume 206, Issue 2, February 2025, Pages 726-734 - Evidence generation throughout paediatric medicines life cycle: findings from collaborative work between European Medicines Agency (EMA) and EUnetHTA on use of extrapolation
Karres D., Pino-Barrio M.J., Benchetrit S., Benda N., Cochat P., Galluzzo S., Garcia-Solis A., Gonzalez S., de Lisa R., Khan D., Lankester R., Lentz F., Martinez-Ortega P.A., Montilla S., Morales D.R., Tshinanu F.M., Sanchez S.P., Montero A.R., Scherer S., Thomson A., Garrido B.T., Umuhire D., Wang S., Bax R., Hedberg N.
British Journal of Pharmacology, Volume 182, Issue 3, February 2025, Pages 484-494 - Real life data of ONC201 (dordaviprone) in pediatric and adult H3K27-altered recurrent diffuse midline glioma: Results of an international academia-driven compassionate use program
Di Carlo D., Annereau M., Vignes M., Denis L., Epaillard N., Dumont S., Guyon D., Rieutord A., Jacobs S., Salomon V., Yoldjian I., Duperray F., Brunel L., Baiao X., Lemos F., Vauleon E., Capra M., Abbou S., Touat M., Sanson M., Gandemer V., De Carli E., Bourdeaut F., Hezam I., Vassal G., Grill J.
European Journal of Cancer, Volume 216, 5 February 2025, 115165 - Platelet Additive Solutions and Pathogen Reduction Impact on Transfusion Safety, Patient Management and Platelet Supply
Andreu G., Boudjedir K., Meyer N., Carlier M., Drouet C., Py J.-Y., Tacquard C., Mertes P.M., Sandid I.
Transfusion Medicine Reviews, Volume 39, Issue 1, January 2025, 150875 - Le dispositif des préparations pharmaceutiques dans la gestion des ruptures de stocks de médicaments à l’Agence nationale de sécurité du médicament et des produits de santé
Bouley M, Rogeau B, Mazet R, Grange Y, Duperray F, Renaud G, Salomon V
Annales Pharmaceutiques Francaises, Volume 83, Issue 5, September 2025, Pages 981-991 - The enhanced national pharmacovigilance system implemented for COVID-19 vaccines in France: A 2-year experience report
Crommelynck S, Grandvuillemin A, Ferard C, Mounier C, Gault N, Pierron E, Jacquot B, Vaillant T, Chatelet IPD, Jacquet A, Salvo F, Alt M, Bagheri H, Micallef J, Pariente A, Gautier S, Valnet-Rabier MB, Atzenhoffer M, Lepelley M, Cottin J, Lacroix I, Gras V, Massy N, Dhanani A, Vella P, Shaim Y, Baril L, Jonville-Bera AP, Benkebil M
Therapie, Volume 80, Issue 4, July–August 2025, Pages 429-437
Articles publiés en 2024
- Evidence generation throughout paediatric medicines life cycle: findings from collaborative work between European Medicines Agency (EMA) and EUnetHTA on use of extrapolation
Karres D., Pino-Barrio M.J., Benchetrit S., Benda N., Cochat P., Galluzzo S., Garcia-Solis A., Gonzalez S., de Lisa R., Khan D., Lankester R., Lentz F., Martinez-Ortega P.A., Montilla S., Morales D.R., Tshinanu F.M., Sanchez S.P., Montero A.R., Scherer S., Thomson A., Garrido B.T., Umuhire D., Wang S., Bax R., Hedberg N.
British Journal of Pharmacology. (no pagination), 2024. Date of Publication: 2024. - Artificial intelligence integration in the drug lifecycle and in regulatory science: policy implications, challenges and opportunities
Oualikene-Gonin W., Jaulent M.-C., Thierry J.-P., Oliveira-Martins S., Belgodere L., Maison P., Ankri J.
Frontiers in Pharmacology. 15(no pagination), 2024. Article Number: 1437167. Date of Publication: 2024. - An examination of process models and model risk frameworks for pharmaceutical manufacturing
O'Connor T.F., Chatterjee S., Lam J., de la Ossa D.H.P., Martinez-Peyrat L., Hoefnagel M.H.N., Fisher A.C.
International Journal of Pharmaceutics: X. 8(no pagination), 2024. Article Number: 100274. Date of Publication: December 2024. - Studying the Impact of European Union Regulatory Interventions for Minimising Risks From Medicines: Lessons Learnt and Recommendations
Goedecke T., Martirosyan L., Gault N., Seifert K., Morales D., Bahri P., Strassmann V., Huber M., Straus S.
Pharmacoepidemiology and Drug Safety. 33(8) (no pagination), 2024. Article Number: e5874. Date of Publication: August 2024. - Frequencies and causes of ABO-incompatible red cell transfusions in France, Germany and the United Kingdom
Mirrione-Savin A, Aghili Pour H, Swarbrick N, Muller S, Bacquet C, Malard L, Murphy MF, Richard P, Davies J, Rowley M, Poles D, Sandid I, Funk MB, Narayan S, Tiberghien P, Schafer R
British Journal of Haematology. 2024 Oct 30. - Establishment of hepatitis A virus coating reagent batch 2 for in vitro potency assay of hepatitis A vaccines by ELISA
Morgeaux S, Manniam I, Le Tallec D, Chagnaud P, Costanzo A
Pharmeuropa bio & scientific notes. 2024:240-250, 2024. - Validation of an ELISA method for determination of physical particle titre of AAV2-based vector preparations
Costanzo A, Regourd E, Ridoux V
Pharmeuropa bio & scientific notes. 2024:221-233, 2024. - Balancing drug regulation and health democracy: The role of patient and healthcare professional advisors at the ANSM.
Concilier regulation du medicament et democratie sanitaire : role des conseillers patient ou professionnel de sante a l'ANSM
Maison P., Bacon T., Daynes P., Decoene C., Mazet R., Vial T., Vignot S., Belgodere L., Oualikene-Gonin W., Ratignier-Carbonneil C.
Therapies, Volume 80, Issue 3, May–June 2025, Pages 311-317 - Real-World Evidence to Support EU Regulatory Decision Making-Results From a Pilot of Regulatory Use Cases
Prilla S., Groeneveld S., Pacurariu A., Restrepo-Mendez M.C., Verpillat P., Torre C., Gartner C., Mol P.G.M., Naumann-Winter F., Breen K.C., Gault N., Gross-Martirosyan L., Benchetrit S., Aylward B., Stoyanova-Beninska V., O'Donovan M., Straus S., Kjaer J., Arlett P.
Clinical Pharmacology and Therapeutics. (no pagination), 2024. Date of Publication: 2024. - Determining recommended acceptable intake limits for N-nitrosamine impurities in pharmaceuticals: Development and application of the Carcinogenic Potency Categorization Approach (CPCA).
Kruhlak N.L., Schmidt M., Froetschl R., Graber S., Haas B., Horne I., Horne S., King S.T., Koval I.A., Kumaran G., Langenkamp A., McGovern T.J., Peryea T., Sanh A., Siqueira Ferreira A., van Aerts L., Vespa A., Whomsley R.
Regulatory Toxicology and Pharmacology. 150(no pagination), 2024. Article Number: 105640. Date of Publication: June 2024. - Prevalence of pulmonary tuberculosis and HIV infections and risk factors associated to tuberculosis in detained persons in Antananarivo, Madagascar
Rakotomanana F., Dreyfus A., Randrianarisoa M.M., Raberahona M., Chevallier E., Andriamasy H.E., Bernardson B.A., Ranaivomanana P., Ralaitsilanihasy F., Rasoamaharo M., Randrianirisoa S.A.N., Razafindranaivo T.A., Rakotobe L., Ratefiharimanana A., Randriamanana D.A., Rakotondrazanany H., Cauchoix B., Baril L., Rakotosamimanana N., Randremanana R.V.
Scientific reports. 14(1) (pp 8640), 2024. Date of Publication: 15 Apr 2024. - 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. 119(3) (pp 212-218), 2024. Date of Publication: March 2024. - Estimands in CNS trials - A review of strategies for addressing intercurrent events.
Meszaros L., Lasch F., Delafont B., Guizzaro L.
Contemporary Clinical Trials Communications. 38(no pagination), 2024. Article Number: 101266. Date of Publication: April 2024. - Neurodevelopmental outcomes after prenatal exposure to lamotrigine monotherapy in women with epilepsy: a systematic review and meta-analysis
Peron A., Picot C., Jurek L., Nourredine M., Ripoche E., Ajiji P., Cucherat M., Cottin J.
BMC Pregnancy and Childbirth. 24(1) (no pagination), 2024. Article Number: 103. Date of Publication: December 2024. - 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 A.-K., Elferink A.
European Psychiatry. 67(1) (no pagination), 2024. Article Number: e2. Date of Publication: 15 Dec 2024. - The enhanced national pharmacovigilance system implemented for COVID-19 vaccines in France: A 2-year experience report
Samuel Crommelynck, Aurélie Grandvuillemin, Claire Ferard, Céline Mounier, Nathalie Gault, Evelyne Pierron, Baptiste Jacquot, Tiphaine Vaillant, Isabelle Parent du Chatelet, Alexis Jacquet, Francesco Salvo 7 , Martine Alt, Haleh Bagheri, Joëlle Micallef, Antoine Pariente, Sophie Gautier, Marie-Blanche Valnet-Rabier, Marina Atzenhoffer, Marion Lepelley, Judith Cottin, Isabelle Lacroix, Valérie Gras, Nathalie Massy, Alban Dhanani, Philippe Vella, Youssef Shaim, Laurence Baril, Annie-Pierre Jonville-Béra, Mehdi Benkebil ; 30 French Regional Pharmacovigilance Centres
Therapies. 14 November 2024 - Le risque transfusionnel en 2024. Transfusion risk in 2024
Agnès Bazin, Karim Boudjedir, Bernard Lassale, Corinne Lorriaux, Maryse Puntous, Jean-Yves Py, Imad Sandid
Anesthésie & Réanimation, Volume 10, Issues 5–6, December 2024. Pages 435-452
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
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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
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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 ?
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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
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