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
2026 Review on organs-on-chips for medicines safety assessment: A European regulatory perspective

ALTEX.  43(1): 98-112

Joana M.D. Portela, Polly Paul, Orla Moriarty, Peter Theunissen, Sonja Beken, Susanne Brendler-Schwaab, Corinne de Vries, Stefano Ponzano
2026 From animal testing to model-informed drug development: building on ICH M15 and EMA initiatives to make new approach methodologies (NAMs) deliver Frontiers in Pharmacology. doi: 10.3389/fphar.2026.1877947 Jean-Michel Dogné, Médéa Locquet, Flora Musuamba, Sonja Beken
2026 Revisiting ICH S7A after 25 years: Outcomes of a multi-stakeholder workshop and strategic pillars for modernizing safety pharmacology Regulatory Toxicology and Pharmacology. doi: 10.1016/j.yrtph.2026.106096

Jean-Pierre Valentin, Sonja Beken, Yasunari Kanda, Derek Leishman, Jennifer B Pierson, Colleen M Pike, Jan Turner

Datum publicatie Artikel/advies Tijdschrift/overheidsinstelling Auteurs
07.10.2025 The impact of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) to address shortages of human and veterinary medicines across Europe Frontiers in Public Health Inga Abed, Vanessa Bennett, Brendan Cuddy, Sandra Dang,
Juan García Burgos, Domenico Di Giorgio, Maria Lamas,
Momir Radulovic, Nuno Simões, Rui Santos Ivo,
Hugues Malonne, Monica Dias
26.07.2025 Evaluation of Awareness of Photosensitivity Risk and Additional Risk Minimisation Measures for Ketoprofen Gel in Belgium and Luxembourg Drugs - Real World Outcomes Veselina Skrinska-Kirilova, Javier Sawchik, Martine Sabbe, Martine Debacker, Guy Weber, Anne-Cécile Vuillemin & Jamila Hamdani 
10.02.2025 From guideline to practice: three years of ICH S11 insights and recommendations Frontiers in Medicine Diana Tavares, Hsiao-Tzu Chien, Maria Elzbieta Sheean, Peter Theunissen, Peter van Meer, Karen Van Malderen

2025

Biology-inspired dynamic microphysiological system approaches to revolutionize basic research, healthcare and animal welfare

ALTEX. 2025;42(2):204-223

Uwe Marx, Sonja Beken, Zaozao Chen, Eva-Maria Dehne, Ann Doherty, Lorna Ewart, Suzanne C Fitzpatrick, Linda G Griffith, Zhongze Gu, Thomas Hartung, James Hickman, Donald E Ingber, Seiichi Ishida, Jayoung Jeong, Marcel Leist, Lisa Levin, Donna L Mendrick, Giorgia Pallocca, Stefan Platz, Marian Raschke, Lena Smirnova, Danilo A Tagle, Martin Trapecar, Bas W M van Balkom, Janny van den Eijnden-van Raaij, Andries van der Meer, Adrian Roth

2025

New approach Methodologies: EU regulatory horizons Nature Reviews Drug Discovery 24(8): 571-572

Mariana Edwards, Oriane Blanquie, Orla Moriarty, Sonja Beken, Falk Ehmann

Datum publicatie Artikel/advies Tijdschrift/overheidsinstelling Auteurs
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

2024

Role of standards and funding in accelerating the development and use of microphysiological systems

ALTEX. 2024;41(4):669-670

Surat Parvatam, Harshita Mittal, Francesca Pistollato, Kasturi Mahadik, Lorna Ewart, Abhijit Majumder, Y K Gupta, Sonja Beken, Rajeshwari Adheseshan, Glyn Stacey, Vishal Gandhi, Dhiraj Kumar, Helder Constantino, Goutami Nayak, Tejaswini Ghurde, Mousumi Gupta, Alokparna Sengupta, Troy Seidle

2024 Taking the leap toward human-specific nonanimal methodologies: The need for harmonizing global policies for microphysiological systems

Stem Cell Reports. 19(1):37-40

Surat Parvatam, David Pamies, Francesca Pistollato, Sonja Beken, Indumathi Mariappan, Adrian Roth, Monica Piergiovanni, Benoît G C Maisonneuve, Lorna Ewart, Abhijit Majumder, Prajakta Dandekar, Rahul Date, Kasturi Mahadik, Saravanan Thiyagarajan, Sandra Coecke

2024

Considerations from an International Regulatory and Pharmaceutical Industry (IQ MPS Affiliate) Workshop on the Standardization of Complex In Vitro Models in Drug Development Advanced Biology (Weinh). 2024 Aug;8(8):e2300131

Lindsay Tomlinson, Diane Ramsden, Sofia Batista Leite, Sonja Beken, Jessica A Bonzo, Paul Brown, Pelin L Candarlioglu, Tom S Chan, Eugene Chen, Colin K Choi, Rhiannon David, Nathalie Delrue, Patrick J Devine, Kevin Ford, Martha Iveth Garcia, James R Gosset, Philip Hewitt, Kimberly Homan, Onyi Irrechukwu, Anna K Kopec, Jennifer L Liras, Sandhya Mandlekar, Arek Raczynski, Nakissa Sadrieh, Melanie Z Sakatis, Jeffrey Siegel, Kyung Sung, Ilona Sunyovszki, Terry R Van Vleet, Jason E Ekert, Rhiannon N Hardwick

Datum publicatie Artikel/advies Tijdschrift/overheidsinstelling Auteurs
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, Marcella Mori, Angélique Kamugisha, Loïc Debehault, Michael Canfyn, Bart Ceyssens, Hans Van Der Meersch, Koenraad van Hoorde, Eric Deconinck and 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

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

2023

EMA commentary on the ICH guideline for testing for carcinogenicity of pharmaceuticals British Journal of Clinical Pharmacology. 89(8):2341-2348

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

2023

3Rs implementation in veterinary vaccine batch-release testing: Current state-of-the-art and future opportunities. A webinar and workshop report Biologicals. 83:101695

Laura Viviani, Elisabeth Balks, Sonja Beken, Anna-Maria Brady, Rick Clayton, Florence Cliquet, Liys Desmayanti, Silvia Fragoeiro, Terrie Jo Hamtak, David John, Carmen Jungbaëck, M Kalaivani, Imke Kross, Catherine Lang, Ni Made Ria Isriyanthi, Laurent Mallet, Catherine Milne, Michelle Rubbrecht, Botond Siklódi, Brajesh Singh, Geetha B Srinivas, Paul Stickings, Catrina Stirling, Pushpanathan Sundram, Mária Szabó, Anne Thomas, Mariette van den Berg, Angela Walker, Corinne Philippe, Joris Vandeputte

2023

Exposure considerations in human safety assessment: Report from an EPAA Partners' Forum Regulatory Toxicology and Pharmacology. 144:105483

Mark T D Cronin, Nicholas Ball, Sonja Beken, Hans Bender, Ofelia Bercaru, Laura Caneva, Marco Corvaro, Richard A Currie, Jeffrey L Dawson, Paul Desert, Sylvia E Escher, Antonio Franco, Amaia Irizar, Jyotigna M Mehta, Vera Rogiers, Raphaël T Tremblay, Carl Westmoreland, Gavin Maxwell

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)
 
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

2022 Organ-on-a-chip: current gaps and future directions Biochemical Society Transactions. 50(2):665-673 Pelin L Candarlioglu, Gianni Dal Negro, David Hughes, Frances Balkwill, Kate Harris, Hazel Screen, Hywel Morgan, Rhiannon David, Sonja Beken, Olivier Guenat, Wendy Rowan, Augustin Amour
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

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-Co

Journal of Immunological 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
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

05.2018

Randomized clinical trials and observational studies in the assessment of drug safety Rev Epidemiol Sante Publique; 66(3):217-225 Sawchik J, Hamdani J, Vanhaeverbeek M.

 

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

2017

Comparing rat and rabbit embryo-fetal developmental toxicity data for 379 pharmaceuticals: on systemic dose and developmental effects

Critical Reviews in Toxicology, 7(5):402-414

Peter T Theunissen, Sonja Beken, Bruce Beyer, William J Breslin, Gregg D Cappon, Connie L Chen, Gary Chmielewski, Luc de Schaepdrijver, Brian Enright, Jennifer E Foreman, Wafa Harrouk, Kok-Wah Hew, Alan M Hoberman, Julia Y Hui, Thomas B Knudsen, Susan B Laffan, Susan L Makris, Matthew Martin, Mary Ellen McNerney, Christine L Siezen, Dinesh J Stanislaus, Jane Stewart, Kary E Thompson, Belen Tornesi, Jan Willem Van der Laan, Gerhard F Weinbauer, Sandra Wood, Aldert H Piersma

2017

Biology-inspired Microphysiological Systems to Advance Patient Benefit and Animal Welfare in Drug Development ALTEX,  37(3):364-394

Uwe Marx, Takafumi Akabane, Tommy B Andersson, Elizabeth Baker, Mario Beilmann, Sonja Beken, Susanne Brendler-Schwaab, Murat Cirit, Rhiannon David, Eva-Maria Dehne, Isabell Durieux, Lorna Ewart, Suzanne C Fitzpatrick, Olivier Frey, Florian Fuchs, Linda G Griffith, Geraldine A Hamilton, Thomas Hartung, Julia Hoeng, Helena Hogberg, David J Hughes, Donald E Ingber, Anita Iskandar, Toshiyuki Kanamori, Hajime Kojima, Jochen Kuehnl, Marcel Leist, Bo Li, Peter Loskill, Donna L Mendrick, Thomas Neumann, Giorgia Pallocca, Ivan Rusyn, Lena Smirnova, Thomas Steger-Hartmann, Danilo A Tagle, Alexander Tonevitsky, Sergej Tsyb, Martin Trapecar, Bob Van de Water, Janny Van den Eijnden-van Raaij 7, Paul Vulto, Kengo Watanabe, Armin Wolf, Xiaobing Zhou, Adrian Roth

2017 Opportunities for use of one species for longer-term toxicology testing during drug development: A cross-industry evaluation

Regulatory Toxicology and Pharmacology 113, 14624 (Epub)

Helen Prior, Paul Baldrick, Sonja Beken, Helen Booler, Nancy Bower, Paul Brooker, Paul Brown, Brian Burlinson, Leigh Ann Burns-Naas, Warren Casey, Melissa Chapman, David Clarke, Lolke de Haan, Olaf Doehr, Noel Downes, Meghan Flaherty, Nichola Gellatly, Sophia Gry Moesgaard, Jennifer Harris, Mark Holbrook, Julia Hui, David Jones, Keith Jones, Hilla Kedar, Andreas Mahl, Alli Manninen, Aidan McGuire, Elisabeth Mortimer-Cassen, Marjorie Peraza, Michael K Pugsley, Jacques Richard, Ruth Roberts, Wendy Roosen, Andreas Rothfuss, Ankie Schoenmakers, Fiona Sewell, Richard Weaver, Lucinda Weir, Alison Wolfreys, Ian Kimber

2017 Building confidence in skin sensitization potency assessment using new approach methodologies: report of the 3rd EPAA Partners Forum, Brussels, 28th October 2019

Regulatory Toxicology and Pharmacology 117:104767

D. Basketter, S. Beken, H. Bender, J. Bridges, S. Casati, M. Corvaro, S. Cuvellier, B. Hubesch, A. Irizar, M.N. Jacobs, P. Kern, F. Lamplmair, I. Manou, B.P. Müller, R. Roggerbrand, L.H. Rossi
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.

2016

Biology-inspired microphysiological system approaches to solve the prediction dilemma of substance testing

ALTEX. 33(3):272-321

Uwe Marx, Tommy B Andersson, Anthony Bahinski, Mario Beilmann, Sonja Beken, Flemming R Cassee, Murat Cirit, Mardas Daneshian, Susan Fitzpatrick, Olivier Frey, Claudia Gaertner, Christoph Giese, Linda Griffith, Thomas Hartung, Minne B Heringa, Julia Hoeng, Wim H de Jong, Hajime Kojima, Jochen Kuehnl, Marcel Leist, Andreas Luch, Ilka Maschmeyer, Dmitry Sakharov, Adrienne J A M Sips, Thomas Steger-Hartmann, Danilo A Tagle, Alexander Tonevitsky, Tewes Tralau, Sergej Tsyb, Anja van de Stolpe, Rob Vandebriel, Paul Vulto, Jufeng Wang, Joachim Wiest, Marleen Rodenburg, Adrian Roth

2016

 

Regulatory acceptance of alternative methods in the development and approval of pharmaceuticals

Validation of alternative methods for toxicity testing, Eds. M. Whelan and C. Eskes, Springer, 27 September 2016:33-64

Sonja Beken, Peter Kasper, Jan-Willem van der Laan

2016

Comparison of rat and rabbit embryo-fetal developmental toxicity data for 379 pharmaceuticals: on the nature and severity of developmental effects

Critical Reviews in Toxicology, 46(10):900-910

Peter T Theunissen, Sonja Beken, Bruce K Beyer, William J Breslin, Gregg D Cappon, Connie L Chen, Gary Chmielewski, Luc De Schaepdrijver, Brian Enright, Jennifer E Foreman, Wafa Harrouk, Kok-Wah Hew, Alan M Hoberman, Julia Y Hui, Thomas B Knudsen, Susan B Laffan, Susan L Makris, Matt Martin, Mary Ellen McNerney, Christine L Siezen, Dinesh J Stanislaus, Jane Stewart, Kary E Thompson, Belen Tornesi, Jan Willem Van der Laan, Gerhard F Weinbauer, Sandra Wood 3, Aldert H Piersma

11.2015

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.

2015

“Open Source”–Based Engineered Human Tissue Models: A New Gold Standard for Nonanimal Testing Through Openness, Transparency, and Collaboration, Promoted by the ALEXANDRA Association

Applied In vitro Toxicology, 1, 1, pp. 5-9

Bart De Wever, Alan Goldberg, Chantra Eskes, Erwin Roggen, Philippe Vanparys, Klaus Schröder, Béatrice Le Varlet, Howard Maibach, Sonja Beken, Benoit De Wilde, Constantin Turchina, Ginette Bogaert, Jean-Pierre Bogaert

2015

Removing Obstacles on the Way to Implement 3R Methods in Toxicology: Regulatorys Point of View

Toxicology Letters, 282, 2, S3

Sonja Beken

2015 Knowledge sharing to facilitate regulatory decision-making in regard to alternatives to animal testing: Report of an EPAA workshop

Regulatory Toxicology and Pharmacology, 73(1): 210-226T

Tzutzuy Ramirez, Sonja Beken, Magda Chlebus, Graham Ellis, Claudius Griesinger, Sandra De Jonghe, Irene Manou, Annette Mehling, Kerstin Reisinger, Laura H Rossi, Jan van Benthem, Jan Willem van der Laan, Renate Weissenhorn, Ursula G Sauer

2015

Impact Analysis of ICH S9 on Non-Clinical Development of Anticancer Drugs

Regulatory Toxicology and Pharmacology, 73(1) 361-366

Milton Bonelli, Francesca Di Giuseppe, Sonja Beken

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 

2014

Impact of Silver Nanoparticles on Haemolysis, Platelet Function and Coagulation

Nanobiomedicine, 4(7):1-9

Julie Laloy, Valentine Minet, Lutfiye Alpan, François Mullier, Sonja Beken, Olivier Toussaint, Stéphane Lucas, Jean-Michel Dogné

2014

Regulatory acceptance and use of 3R models for pharmaceuticals and chemicals: Expert opinions on the state of affairs and the way forward

Regulatory Toxicology and Pharmacology, 69:41-48

Marie-Jeanne W A Schiffelers, Bas J Blaauboer, Wieger E Bakker, Sonja Beken, Coenraad F M Hendriksen, Herman B W M Koëter, Cyrille Krul

2014

Towards a comparative retrospective analysis of rat and rabbit developmental toxicity studies for pharmaceutical compounds

Reproductive Toxicology 47:27-32

Peter Theunissen, Sonja Beken, Gregg Cappon, Connie Chen, Alan Hoberman, Jan-Willem van der Laan, Jane Stewart, Aldert Piersma

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

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* 
2008

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*

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

Macromolecules 2004, 37, 8739-8744

B. Stubbe, W.E. Hennink, 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
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