Bibliographie
Les membres du personnel de l’EDQM présentant un haut niveau de qualification contribuent régulièrement à des articles scientifiques publiés dans diverses revues. La liste ci-dessous répertorie tous ceux parus au cours de l’année 2023.
Publications externes
- Bernat J. L., Domínguez-Gil B., Glazier A. K. et al. (2023), « Understanding the Brain-based Determination of Death When Organ Recovery Is Performed With DCDD In Situ Normothermic Regional Perfusion », Transplantation, 2023, vol. 107, nº 8.
- Blöndal A. B., Magnússon E., Ravera S. (2024), « The role of electronic leaflets in improving access to medication-related information », Communication and Medicine, 2023, vol. 19, nº 1.
- Chandrasekar A., Lomas R., Sánchez-Ibáñez J. et al. (2023), « Physical Examination of Potential Deceased Organ and Tissue Donors: An Overview of the European Landscape », Transplant International, 2023, vol. 36.
- Cirefice G., Schütte K., Spreitzer I. et al. (2023), « The future of pyrogenicity testing: Phasing out the rabbit pyrogen test. A meeting report », Biologicals, 2023, vol. 84, 101702.
- Deconinck E., Raimondo M., Borioni A. et al. (2023), « Clustering of Tadalafil API Samples According to their Manufacturer in the Context of API Falsification Detection », Journal of Pharmaceutical Sciences, 2023, vol. 112, nº 11, p. 2834-2842.
- Khan A. S., Mallet L., Blümel J. et al. (2023), « Report of the third conference on next-generation sequencing for adventitious virus detection in biologics for humans and animals », Biologicals, 2023, vol. 83, 101696.
- Kolaj-Robin O., Dufour M.-T. (2023), « European Pharmacopoeia’s Approach to Cell and Gene Therapy: Focus on How Gene Therapy Texts Are Evolving », Advances in Experimental Medicine and Biology, 2023, vol. 1430.
- Mihály S., Smudla A., Dominguez-Gil B. et al. (2023), « Approaching the Families of Potential Deceased Organ Donors: An Overview of Regulations and Practices in Council of Europe Member States », Transplant International, 2023, vol. 36.
- Milne C., Wagner R., Cano F. et al. (2023), « Independent control of COVID-19 vaccines by EU Official Control Authority Batch Release: challenges, strengths and successes », npj Vaccines 2023, vol. 8, nº 22.
- Ndomondo-Sigonda M., Azatyan S., Doerr P. et al. (2023), « Best practices in the African Medicines Regulatory Harmonization initiative: Perspectives of regulators and medicines manufacturers », PLOS Glob Public Health,2023, vol. 3, nº 4, e0001651.
- Ravera S., Henman M. C. (2023), « Council of Europe’s guidelines to harmonize the medication review process in Europe », dans « FIP Seville 2022: Social and Administrative Pharmacy », FIP Seville 2022: Social and Administrative Pharmacy, Pharmacy Education, 2023, vol. 23, nº 3.
- Reid K., Hecquet M.-L. (2023), « Industry is Urging EMA to Increase its Focus on Medicine Impact of EU Food, Chemical, and Environmental Legislation », International Pharmaceutical Quality (IPQ), 21 juillet 2023.
- Sánchez Ibáñez J., Bokhorst A., Chandrasekar A. et al. (2023a), « Protection of haematopoietic progenitor cell donors: an updated overview of the European landscape », Bone Marrow Transplant,vol. 58, p. 842-848.
- Sánchez Ibáñez J., Humphreys C., Lomero M. et al. (2023b), « Tissue and Cell Donation: Recommendations From an International Consensus Forum », Transplantation Direct, vol. 9, nº 5, e1466.
- Urbańczyk K., Guntschnig S., Antoniadis V. et al. (2023), « Recommendations for wider adoption of clinical pharmacy in Central and Eastern Europe in order to optimise pharmacotherapy and improve patient outcomes », Frontiers in Pharmacology, 2023, vol. 14.
- Viviani L., Balks E., Beken S. et al. (2023), « 3Rs implementation in veterinary vaccine batch-release testing: Current state-of-the-art and future opportunities. A webinar and workshop report », Biologicals, vol. 83, 101695.
- Yang J., Kakarla R., Marzan T. et al. (2023), « Performance Characteristics of Mass Spectrometry-Based Analytical Procedures for Quantitation of Nitrosamines in Pharmaceuticals: Insights from an Inter-laboratory Study », Journal of Pharmaceutical Sciences, vol. 112, nº 10.
Pharmeuropa Bio & Scientific Notes
Pharmeuropa Bio & Scientific Notes a pour objectif de diffuser des connaissances sur les méthodes d’analyse applicables au contrôle qualité pharmaceutique, en particulier les résultats obtenus pour les produits pharmaceutiques. Cette revue contient des articles scientifiques relatifs à la standardisation biologique, qui mettent principalement l’accent sur le Programme de standardisation biologique de l’EDQM et sur les travaux de la Pharmacopée Européenne (Ph. Eur.). Elle comporte également des rapports d’établissement d’étalons de référence clés de la Ph. Eur. (PBR/SCR/RBR) pour les produits biologiques.
Tous les articles publiés dans Pharmeuropa Bio & Scientific Notes en 2023 sont disponibles à l’adresse https://pbiosn.edqm.eu/app/pbiosn/search?chapter=165869&title=2023.
- Esposito V., Carocci A., Luciani F. et al. (2023), « Validation and application of a SEC-HPLC method for the determination of total protein in therapeutic immunoglobulins as an alternative to the European Pharmacopoeia methods ». Pharmeur Bio Sci Notes. 2023, p. 69-80.
- Garcia-Moreno S., Mulloy B., Rodrigo-Castro I. et al. (2023), « Collaborative study for the establishment of replacement batches of Ph. Eur. Heparin Low-Molecular-Mass for Calibration CRS ». Pharmeur Bio Sci Notes. 2023, p. 82-111.
- Pisani G., Le Tallec D., Costanzo A. « Establishment of Ph. Eur. Hepatitis C Virus RNA for NAT testing BRP batch 2 ». Pharmeur Bio Sci Notes. 2023, p. 15-41.
- Raut S., Daas A., Rigsby P. et al. (2023), « Assay discrepancies using human coagulation factor VIII chromogenic kits: Results from a plasma-derived factor VIII collaborative study (BSP112) ». Pharmeur Bio Sci Notes. 2023, p. 1-14.
- Ridoux V., Laurens S., Venturini S., Le Tallec D., Costanzo A. (2023), « Validation of a qPCR method for determination of viral genome titres of AAV2-based vector preparations ». Pharmeur Bio Sci Notes. 2023, p. 42-59.
- Le Maux S., Closson-Carella V., Kolaj-Robin O. et al. (2023), « Informal investigation on the added value of a potential certification system for the qualification of raw materials for the production of ATMPs ». Pharmeur Bio Sci Notes. 2023, p. 60-68.
