Wetenschappelijke publicaties

 Hieronder vindt u het overzicht van de wetenschappelijke publicaties waar medewerkers van het FAGG aan meegewerkt hebben.

Datum publicatie Artikel/advies Tijdschrift/overheidsinstelling Auteurs
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


Cohort Event Monitoring of Adverse Reactions to COVID-19 Vaccines in Seven European Countries: Pooled Results on First Dose

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


Datum publicatie Artikel/advies Tijdschrift/overheidsinstelling Auteurs
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)
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


Improvement of transfusion practice and reduction in red blood cell utilization in Belgian hospitals: Results of a national survey and benchmarking

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 Evaluation of the effectiveness of direct healthcare professional communication regarding new dosage of paracetamol paediatric syrup

Pharmacoepidemiology and Drug Safety

Françoise Wuillaume, Martine Sabbe, Javier Sawchik, Jamila Hamdani
10.04.2020 Survey on prescription stimulant use among university students in Wallonia and Brussels:
prevalence, motives and perceived effects
Survey performed in October 2018

Federal Agency for Medicines and Health Products

Javier Sawchik, Martine Sabbe, Mégane Gräfe
Françoise Wuillaume, Jamila Hamdani, Hugues Malonne

10.01.2019 Borstimplantaat-geassocieerd anaplastisch grootcellig lymfoom (breast implant associated-anaplastic large cell lymphoma, bia-alcl)

Hoge Gezondheidsraad

Decaluwe Kelly; De Mey Albert

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


Recruitment barriers for prophylactic vaccine trials: a study in Belgium Vaccine Lauriane Harrington, , Pierre Van Damme, , Corinne Vandermeulen, Stéphanie Mali


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
10.2016 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.


Birth Control in Clinical Trials: Industry Survey of Current Use Practices, Governance, and Monitoring

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 Advies 8866 -Analyse van de globale toxiciteit van aluminium en blootstellingsberekening met eenbijzondere aandacht voor aluminiumverbindingen in cosmetica Hoge Gezondheidsraad K. De Smet
14.07.2015 Advies 12-2015 –Betreft: Residuen van gewasbeschermingsmiddelen en van diergeneesmiddelen in bijenwas : scenarioanalyse van de chronische blootstelling van de consumenten en voorstel van actielimieten (SciCom 2014/13) AFSCA De werkgroep was samengesteld uit:
Leden van het Wetenschappelijk Comité:
C. Saegerman (verslaggever), P. Delahaut, P. Gustin, A. Legrève, M.-L. Scippo, W. Steurbaut
Externe experten: D. de Graaf (UGent), B.K. Nguyen (ULg – GxABT), W. Reybroeck (ILVO), B. Urbain (FAGG)
Dossierbeheerder: O. Wilmart (FAVV)
De activiteiten van de werkgroep werden opgevolgd door de volgende leden van de administratie: C. Rettigner (FAVV) en C. Vinkx (FOD Volksgezondheid, Veiligheid van de Voedselketen en Leefmilieu)
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. andDan 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*

With comments in: 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* 

Synergism between particle-based multiplexing and microfluidics technologies may bring diagnostics closer to the patient

Analytical and Bioanalytical Chemistry 2008, 391(7), 2453-2467 S. Derveaux, B.G. Stubbe, K. Braeckmans, C. Roelant, J. Demeester, S.C. De Smedt*


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


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


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


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

Macromolecules 2004, 37, 8739-8744

B. Stubbe, W.E. Hennink, S.C. De Smedt*, J. Demeester


“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
Laatste update op 25/07/2023