Bibliography
The highly qualified EDQM staff regularly contributes to scientific articles published in a variety of journals. The list below presents the articles published in 2023.
External publications
- 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;107:8.
- Blöndal, A. B., Magnússon, E., & Ravera, S. (2024), “The role of electronic leaflets in improving access to medication-related information”, Communication and Medicine, 2023;19:1.
- 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;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;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;112(11):2834-42.
- 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, Volume 2023;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 No. 1430, Maria Cristina Galli (Ed.), Springer.
- Mihály S., Smudla A., Domínguez-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;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;8:22.
- 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;3:4:e0001651
- Ravera S., Henman M. C. (2023), “Council of Europe’s guidelines to harmonize the medication review process in Europe”, FIP Seville 2022: Social and Administrative Pharmacy, Pharmacy Education, 2023;23:3.
- 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 July 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 2023;58:842-848.
- Sánchez Ibáñez J., Humphreys C., Lomero M. et al. (2023b), “Tissue and Cell Donation: Recommendations From an International Consensus Forum”, Transplantation Direct, 2023;9:5: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;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, 2023;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, 2023;112:10.
Pharmeuropa Bio & Scientific Notes
Pharmeuropa Bio & Scientific Notes seeks to disseminate knowledge on methods of analysis for pharmaceutical quality control, with a particular emphasis on the results obtained for pharmaceutical products. The journal publishes scientific articles related to biological standardisation with a primary focus on the EDQM Biological Standardisation Programme and the work of the European Pharmacopoeia (Ph. Eur.). It also includes reports on the establishment of key Ph. Eur. reference standards (BRP/CRS/BRR) for biologicals.
All articles published in Pharmeuropa Bio & Scientific Notes in 2023 can be found at: 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, 2023:69-80.
- 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, 2023:82-111.
- Pisani G., Le Tallec D., Costanzo A. (2023), “Establishment of Ph. Eur. Hepatitis C Virus RNA for NAT testing BRP batch 2”, Pharmeur Bio Sci Notes, 2023:15-41.
- 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, 2023:1-14.
- 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, 2023:42-59.
- Le Maux, V. Closson-Carella, O. Kolaj-Robin 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, 2023:60-68.
