You will find below the summary of the scientific publications to which employees of the FAMHP contributed.
Publication date | Article/advice | Journal/public institution | Authors |
18.03.2024 | Inherited retinal dystrophies and orphan designations in the European Union | European Journal of Ophthalmology | Jane Moseley, Tim Leest, Kristina Larsson, Armando Magrelli, and Violeta Stoyanova-Beninska |
09.01.2024 | Taking the leap toward human-specific nonanimal methodologies: The need for harmonizing global policies for microphysiological systems | Stem Cell Reports - ISSCR | Surat Parvatam,David Pamies, Francesca Pistollato, Sonja Beken, Indumathi Mariappan, Adrian Roth, Monica Piergiovanni, Benoıt G.C. Maisonneuve, Lorna Ewart, Abhijit Majumder, Prajakta Dandekar, Rahul Date, Kasturi Mahadik, Saravanan Thiyagarajan, and Sandra Coecke |
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Publication date | Article/advice | Journal/public institution | Authors |
10.11.2023 | Substandard and falsified ivermectin tablets obtained for self-medication during the COVID-19 pandemic as a source of potential harm. | National Library of Medicine National Center for Biotechnology Information |
Celine Vanhee, Bram Jacobs, Angélique Kamugisha, Michael Canfyn, Hans Van Der Meersch, Bart Ceyssens, Eric Deconinck, Koenraad van Hoorde, Marie Willocx |
22.07.2023 | Uncovering the Quality Deficiencies with Potentially Harmful Effects in Substandard and Falsified PDE-5 Inhibitors Seized by Belgian Controlling Agencies | Forensic Sciences | Celine Vanhee, Bram Jacobs, Angélique Kamugisha, Michael Canfyn, Hans Van Der Meersch, Bart Ceyssens, Eric Deconinck, Koenraad van Hoorde, Marie Willocx |
27.04.2023 | EMA commentary on the ICH guideline for testing for carcinogenicity of pharmaceuticals | Brit J Clinical Pharma | Jan Willem van der Laan, Mikael Andersson, Sonja Beken, Milton Bonelli, Susanne Brendler-Schwaab, Rosemary Kane, Markku Pasanen, Stefano Ponzano, Jakob Paur, Christine Siezen, Anne Soleng, Rhys Whomsley |
07.04.2023 |
Drug Saf. 2023 Apr;46(4):391-404. doi: 10.1007/s40264-023-01281-9. Epub 2023 Apr 7. | Monika Raethke, Florence van Hunsel, Nicolas H Thurin, Caroline Dureau-Pournin, Dirk Mentzer, Barbara Kovačić, Nikica Mirošević Skvrce, Evelien De Clercq, Martine Sabbe, Gianluca Trifirò, Nicoletta Luxi, Alexia Giovanazzi, Saad Shakir, Olaf H Klungel, Sandor Schmikli, Miriam Sturkenboom | |
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Publication date | Article/advice | Journal/public institution | Authors |
02.06.2022 | Survey on the use of benzodiazepines and Z-drugs to treat insomnia in Belgium | Federal Agency for Medicines and Health Products | Sophie Kiridis (FAMHP), Javier Sawchik (FAMHP), Nele Maenhaut (FAMHP), Martine Sabbe (FAMHP), Françoise Wuillaume (FAMHP), Jamila Hamdani (FAMHP) |
16.02.2022 |
Use and misuse of prescription stimulants by university students: a cross-sectional survey in the french-speaking community of Belgium | National Library of Medicine National Center for Biotechnology Information |
Martine Sabbe, Javier Sawchik, Mégane Gräfe, Françoise Wuillaume, Sara De Bruyn, Pierre Van Antwerpen, Guido Van Hal Martin Desseilles, Jamila Hamdani, Hugues Malonne |
21.01.2022 | Reliable and Scalable SARS-CoV-2 qPCR Testing at a High Sample Throughput: Lessons Learned from the Belgian Initiative | Life | Van Vooren S, Grayson J, Van Ranst M, Dequeker E, Laenen L, Janssen R, Gillet L, Bureau F, Coppieters W, Devos N, Hengchen B, Wattiau P, Méhauden S, Verlinden Y, Van Baelen K, Pattery T, Valentin JP, Janssen K, Geraerts M, Smeraglia J, Hellemans J, Wytynck P, Mestdagh P, Besbrugge N, Höfer R, Nollet F, Vandesompele J, De Smet P, Lebon J, Vandewynckele E, Verstrepen S, Uten W, Capron A, Malonne H, Poels J, André E. |
01.10.2021 | Safety, Immunogenicity and Interchangeability of Biosimilar Monoclonal Antibodies and Fusion Proteins: A Regulatory Perspective | Drugs | Pekka Kurki, Sean Barry, Ingrid Bourges, Panagiota Tsantili, Elena Wolff Holz |
01.10.2021 | Evaluating Diagnostic Accuracy of Saliva Sampling Methods for Severe Acute Respiratory Syndrome Coronavirus 2 Reveals Differential Sensitivity and Association with Viral Load | J Mol Diagn | Pieter Mestdagh, Michel Gillard, Sharonjit K Dhillon, Jean-Paul Pirnay, Jeroen Poels , Jan Hellemans Veronik Hutse, Celine Vermeiren, Maxime Boutier, Veerle De Wever, Patrick Soentjens, Sarah Djebara, Hugues Malonne, Emmanuel André, Marc Arbyn, John Smeraglia, Jo Vandesompele |
09.08.2021 |
International Society of Blood Transfusion | Jana Vanden Broeck, Katrien Beeckman, Evelyne Van Gastel, Luc De Keersmaecker, Timothy Devos, Christiane Gérard, Lucien Noens, Dominique Putzeys, Karin Van Poucke, Margareta Haelterman, Véronique Deneys, Rik Schots | |
24.03.2021 | Diagnostic and analytical performance evaluation of ten commercial assays for detecting SARS-CoV-2 humoral immune response | J Immunol Methods | Marnix Mylemans, Eveline Van Honacker, Louis Nevejan, Stefanie Van Den Bremt, Laura Hofman, Jeroen Poels, Lien Cattoir, An Boel, Lieve Van Hoovels |
15.10.2020 |
Pharmacoepidemiology and Drug Safety | Françoise Wuillaume, Martine Sabbe, Javier Sawchik, Jamila Hamdani | |
10.04.2020 |
Federal Agency for Medicines and Health Products |
Javier Sawchik, Martine Sabbe, Mégane Gräfe |
10.01.2019 |
Lymphome anaplasique à grandes cellules associé à un implant mammaire (LAGC-AIM) | Conseil Supérieur de la Santé | Decaluwe Kelly; De Mey Albert |
29.10.2019 |
International Journal of Toxicology |
Jan Willem van der Laan, Karen van Malderen, Nico de Jager, Dinah Duarte, Gunter F. Egger, Fabien Lavergne, Cláudio Gouveia Roque, Isabel Vieira, Lutz Wiesner, and Jacqueline Carleer |
10.2017 |
Recruitment barriers for prophylactic vaccine trials: a study in Belgium | Vaccine | Lauriane Harrington, , Pierre Van Damme, , Corinne Vandermeulen, Stéphanie Mali |
07.2017 |
Acute kidney injury in the critically ill still remains a challenge |
European Medical Journal p 92 - 100 |
Karin Janssen van Doorn |
10.2016 | Cell-based therapies for cardiac repair: a meeting report on scientific observations and European regulatory viewpoints. | Eur J Heart Fail. 2016 Feb;18(2):133-41. doi: 10.1002/ejhf.422. Epub 2015 Oct 16. | Schüssler-Lenz M, Beuneu C, Menezes-Ferreira M, Jekerle V, Bartunek J, Chamuleau S, Celis P, Doevendans P, O'Donovan M, Hill J, Hystad M, Jovinge S, Kyselovič J, Lipnik-Stangelj M, Maciulaitis R, Prasad K, Samuel A, Tenhunen O, Tonn T, Rosano G, Zeiher A, Salmikangas P. |
10.2016 | Residues in Beeswax: A Health Risk for the Consumer of Honey and Beeswax? | Journal of Agricultural and Food Chemistry website | Co-auteur: Bruno Urbain |
10.2016 |
Clarification on the naming of a VMP and the use of standard terms | Regulatory Rapporteur | Valérie Van Merris, Hedi Hellenurm-Sepp |
06.2016 |
Marketing authorisation transfer to a mutual recognition procedure for a veterinary product |
Regulatory Rapporteur |
Valérie Van Merris, Johan Vanlerberghe, |
02.2016 | Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges | mAbs Journal, 8(3), 427-45. De Smet K. and Van Aerts A., Non-clinical studies for biosimilars (2017) Eds Endrenyi, Declerck and Chow,Taylor and Francis. | Chapman K., Adjei A., Baldrick P., da Silva A., De Smet K., DiCicco R., Hong S.S., Jones D., Leach M., McBlane J., Ragan I., Reddy P., Stewart D., Suitters A. and Sims J. |
11.2015
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Therapeutic Innovation & Regulatory Science |
J. Stewart, W. J. Breslin, B. K. Beyer, K. Chadwick, L. De Schaepdrijver, M. Desai, B. Enright, W. Foster, J. Y. Hui, G. J. Moffat, B. Tornesi, K. Van Malderen, L. Wiesner, and C. L. Chen | |
08.2015 | Avis 8866 -Titre: Analyse de la toxicité globale de l’aluminium et calcul de l’exposition avec une attention particulière pour les composés d’aluminium dans les produits cosmétiques | Hoge Gezondheidsraad | K. De Smet |
14.07.2015 | Avis 12-2015 - Objet : Résidus de produits phytopharmaceutiques et de médicaments vétérinaires dans la cire d’abeille : analyse de scénarios de l’exposition chronique des consommateurs et proposition de limites d’action (SciCom2014/13) | AFSCA | Le groupe de travail était composé de : Membres du Comité scientifique C. Saegerman (rapporteur), P. Delahaut, P. Gustin, A. Legrève, M.-L. Scippo, W. Steurbaut Experts externes : D. de Graaf (UGent), B.K. Nguyen (ULg – GxABT), W. Reybroeck (ILVO), B. Urbain (AFMPS) Gestionnaire du dossier : O. Wilmart (AFSCA) Les activités du groupe de travail ont été suivies par les membres de l’administration suivants : C. Rettigner (AFSCA) et C. Vinkx (SPF Santé publique, Sécurité de la Chaîne alimentaire et Environnement). |
04.2015 | Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Products Successfully to the Market - Report from the CAT-DGTI-GSCN Workshop at the DGTI Annual Meeting 2014. | Transfus Med Hemother. 2015 May;42(3):194-9. doi: 10.1159/000382107. Epub 2015 Apr 28. | Celis P, Ferry N, Hystad M, Schüßler-Lenz M, Doevendans PA, Flory E, Beuneu C, Reischl I, Salmikangas P. |
2015 | Paracetamol use during pregnancy and child neurodevelopment | Dev Med Child Neurol, 57(8), 718-24 | Defays L., Van Malderen K., De Smet K., Verlinden V., Hamdani J., Sawchick J., Dogné J.-M. and Dan B. |
2014 | Animal studies in non-clinical development of biosimilars – a paradigm shift in the EU | mAbs Journal, 6(5), 1155-1162 | Van Aerts A., De Smet K., Reichmann G., van der Laan J.W. and Schneider C. K. |
2014 | Generic chiral method development in SFC and ultra-performance SFC | Journal of Chromatography A 1363 (2014) 311-322 | Katrijn De Klerck, Yvan Vander Heyden and Debby Mangelings |
2014 | Pharmaceutical enantiomer resolution using immobilized polysaccharide-based chiral stationary phases in supercritical fluid chromatography | Journal of Chromatography A 1328 (2014) 85-97 | Katrijn De Klerck, Debby Mangelings, and Yvan Vander Heyden |
2014 | Exploratory data analysis as a tool for similarity assesment and clustering of chiral polysaccharide-based systems in supercritical fluid chromatography | Journal of Chromatography A 1326 (2014) 110-124 | Katrijn De Klerck, Debby Mangelings, and Yvan Vander Heyden |
2014 | Three versus five µm chlorinated polysaccharide-based packings in chiral capillary electrochromatography: efficiency and precision evaluation | Journal of Biomedical Chromatography 28 (2014) 68-81 | Ans Hendrickx, Katrijn De Klerck, Debby Mangelings, Lies Clincke, and Yvan Vander Heyden |
2014 | Three versus five µm chlorinated polysaccharide-based packings in chiral capillary electrochromatography: performance evaluation | Journal of Biomedical Chromatography 28 (2014) 182-191 | Ans Hendrickx, Katrijn De Klerck, Debby Mangelings, Lies Clincke, and Yvan Vander Heyden |
2014 | The occurrence of N-nitrosamines, residual nitrite and biogenic amines in commercial dry fermented sausages and evaluation of their occasional relation | Journal of Meat Science 96 (2) (2014) 821-828 | Evelinde De Mey, Katrijn De Klerck, Hannelore De Maere, Lore Dewulf, Guy Derdelinckx, Marie-Christine Peeters, Ilse Fraeye, Yvan Vander Heyden and Hubert Paelinck |
27.12.2013 | Omentum is better site than kidney capsule for growth, differentiation, and vascularization of immature porcineβ-cell implants in immunodeficient rats | Transplantation. 2013 Dec27;96(12):1026-33 | Bartholomeus K, Jacobs-Tulleneers-Thevissen D, Shouyue S, Suenens K, In't Veld PA, Pipeleers-Marichal M, Pipeleers DG, Hellemans K. |
2013 | Recent advances in SFC for the analysis of chiral and achiral pharmaceuticals | LC/GC Europe Supplement (May 2013) 'Advances in pharmaceutical analysis' | Katrijn De Klerck, Debby Mangelings and Yvan Vander Heyden |
2013 | Updating a generic screening approach in sub- or supercritical fluid chromatography for the enantioresolution of pharmaceuticals | Journal of supercritical fluids 80 (2013) 50-59 | Katrijn De Klerck, Christophe Tistaert, Debby Mangelings and Yvan Vander Heyden |
2012 | Enantioselectivity of polysaccharide-based chiral stationary phases in supercritical fluid chromatography using methanol-containing carbon dioxide mobile phases | Journal of Chromatography A 1269 (2012) 336-345 | Katrijn De Klerck, Greet Parewyck, Debby Mangelings and Yvan Vander Heyden |
2012 | Supercritical fluid chromatography for the enantioseparation of pharmaceuticals | Journal of Pharmaceutical and Biomedical Analysis 69 (2012) 77-92 | Katrijn De Klerck, Debby Mangelings and Yvan Vander Heyden |
2012 | Combined use of isopropylamine and trifluoroacetic acid in methanol-containing mobile phases for chiral supercritical fluid chromatography | Journal of Chromatography A 1234 (2012) 72-79 | Katrijn De Klerck, Debby Mangelings, David Clicq, Filip De Boever and Yvan Vander Heyden |
08.2010 | Human islet cell implants in a nude rat model of diabetes survive better in momentum than in liver with a positive influence of beta cell number and purity | Diabetologia. 2010 Aug;53(8):1690-9 | Jacobs-Tulleneers-Thevissen D, Bartholomeus K, Suenens K, Vermeulen I, Ling Z, Hellemans KH, In't Veld P, Pipeleers-Marichal M, Pipeleers D. |
03.2010 | Challenges with advanced therapy medicinal products and how to meet them. | Nat Rev Drug Discov. 2010 Mar;9(3):195-201. doi: 10.1038/nrd3052. Review. | Committee for Advanced Therapies (CAT); CAT Scientific Secretariat, Schneider CK, Salmikangas P, Jilma B, Flamion B, Todorova LR, Paphitou A, Haunerova I, Maimets T, Trouvin JH, Flory E, Tsiftsoglou A, Sarkadi B, Gudmundsson K, O'Donovan M, Migliaccio G, Ancāns J, Maciulaitis R, Robert JL, Samuel A, Ovelgönne JH, Hystad M, Fal AM, Lima BS, Moraru AS, Turcáni P, Zorec R, Ruiz S, Akerblom L, Narayanan G, Kent A, Bignami F, Dickson JG, Niederwieser D, Figuerola-Santos MA, Reischl IG, Beuneu C, Georgiev R, Vassiliou M, Pychova A, Clausen M, Methuen T, Lucas S, Schüssler-Lenz M, Kokkas V, Buzás Z, MacAleenan N, Galli MC, Linē A, Gulbinovic J, Berchem G, Fraczek M, Menezes-Ferreira M, Vilceanu N, Hrubisko M, Marinko P, Timón M, Cheng W, Crosbie GA, Meade N, di Paola ML, VandenDriessche T, Ljungman P, D'Apote L, Oliver-Diaz O, Büttel I, Celis P. |
2008 | Layer-by-Layer coated digitally encoded microcarriers allow sensitive quantification of proteins in serum and plasma | Analytical Chemistry 2008, 80, 85-94 | S. Derveaux, B. Stubbe, C. Roelant, M. Leblans, B. De Geest, J. Demeester, S.C. De Smedt* |
2008 |
Journal of Proteome Research (2008, 7, 479-480) Evaluation of encoded layer-by-layer coated microparticles as protease sensors |
Advanced Functional Materials 2008, 18(11), 1624-1631 | B.G. Stubbe, S. Gevaert, S. Derveaux,K. Braeckmans, B.G. De Geest, M. Goethals, J. Vandekerckhove, J. Demeester, S.C. De Smedt* |
2008 | Analytical and Bioanalytical Chemistry 2008, 391(7), 2453-2467 | S. Derveaux, B.G. Stubbe, K. Braeckmans, C. Roelant, J. Demeester, S.C. De Smedt* |
2007 |
Influence of free chains on the swelling pressure of PEG-HEMA and dex-HEMA hydrogels |
International Journal of Pharmaceutics 2007, 337, 31-39 |
T.G. Van Thienen, F. Horkay, K. Braeckmans, B.G. Stubbe, J. Demeester, S.C. De Smedt |
2007 |
Digitally encoded drug tablets to combat counterfeiting |
Advanced Materials 2007, 19(22), 3854-3858 With comments in: Nature Materials (Research Highlicht, December 2007) |
F. Fayazpour, B. Lucas, N. Huyghebaert, K. Braeckmans, S. Derveaux, B.G. Stubbe, J.P. Remon, J. Demeester, C. Vervaet, S.C. De Smedt |
09.2007 | Development and application of a simplified clean-up procedure for the determination of polychlorinated biphenyls and polybrominated diphenyl ethers in horse fat by gas chromatography – tandem mass spectrometry | Rapid Communications in Mass Spectrometry 18 (2004) 2317-2322 | C. Naert and C. Van Peteghem |
02.2007 | Distribution of polychlorinated biphenyls and polybrominated diphenyl ethers in birds of prey from Switzerland | Chemosphere 68 (2007) 977-987 | C. Naert, C. Van Peteghem, J. Kupper, L. Jenni and H. Naegeli |
2006 |
Self-exploding lipid coated microgels |
Biomacromolecules 2006, 7, 371-379 |
B.G. De Geest, B.G. Stubbe, A.M. Jonas, T. Van Thienen, W.L.J. Hinrichs, J. Demeester, S.C. De Smedt |
2006 |
Anomalous photobleaching in fluorescence recovery after photobleaching measurements due to excitation saturation - a case study for fluorescein |
Journal of Biomedical Optics 2006, 11(4), 044013 |
K. Braeckmans, B.G. Stubbe, K. Remaut, J. Demeester, and S. C. De Smedt |
02.2006 | Occurrence of polychlorinated biphenyls and polybrominated diphenyl ethers in Belgian human adipose tissue | Archives of Environmental Contamination and Toxicology 50 (2006) 290-296 | C. Naert, M. Piette, N. Bruneel and C. Van Peteghem |
10.09.2004 | Development of a gas chromatograpy/ion trap mass spectrometry based method for the quantification of polybrominated diphenyl ethers and polychlorinated biphenyls in adipose tissue | Rapid Communications in Mass Spectrometry 18 (2004) 2317-2322 | C. Naert, S. De Saeger and C. Van Peteghem |
2004 | Modeling the swelling pressure of degrading hydroxyethylmethacrylate-grafted dextran hydrogels | Journal of Polymer Science-part B: Polymer Physics 2004, 42, 3397-3404 | B.G. Amsden, B. Stubbe, F. Horkay, S.C. De Smedt, J. Demeester |
2004 | Swelling pressure of hydrogels that degrade through different mechanisms | Journal of Polymer Science-part B: Polymer Physics 2004, 42, 3397-3404 | B.G. Amsden, B. Stubbe, F. Horkay, S.C. De Smedt, J. Demeester |
2004 |
“Programmed polymeric devices” for pulsed drug delivery |
Pharmaceutical Research 2004, 21, 1732-1740 |
B. Stubbe, S.C.De Smedt*, J. Demeester |
2003 | Tailoring the swelling pressure of degrading dextran hydroxyethyl methacrylate hydrogels | Biomacromolecules 2003, 4, 691-695 | B.G. Stubbe, F. Horkay, B. Amsden, W.E. Hennink, S.C. De Smedt*, J. Demeester |
2002 | Swelling Pressure Observations on Degrading dex-HEMA Hydrogels | Macromolecules 2002, 35, 2501-2505 | B. G. Stubbe, K. Braeckmans, F. Horkay, W.E. Hennink, S.C. De Smedt*, J. Demeester |
2002 | A comparison between the use of dynamic mechanical analysis and oscillatory shear rheometry for the characterisation of hydrogels | International Journal of Pharmaceutics 2002, 244, 163-168 | T.K.L. Meyvis, B.G. Stubbe, J. Van Steenbergen, W.E. Hennink, S.C. De Smedt , J.Demeester |
2001 | The in Vitro Evaluation of ‘Azo Containing Polysaccharide Gels’ for Colon Delivery | Journal of Controlled Release 2001, 75, 103-114 | B. Stubbe, B. Maris, G. Van den Mooter, S.C. De Smedt* and J. Demeester |