Publications

Van Neste, M., Bogaerts, A., Nauwelaerts, N., Macente, J., Smits, A., Annaert, P., Allegaert, K., (2023) Challenges Related to Acquisition of Physiological Data for Physiologically Based Pharmacokinetic (PBPK) Models in Postpartum, Lactating Women and Breastfed Infants—A Contribution from the ConcePTION Project. Pharmaceutics, 15(11):2618. https://doi.org/10.3390/pharmaceutics15112618

Nordeng, H., Wegler, C., Lindqvist, A., Melander, E., Magnusson, M., Gandia, P., Panchaud., Baranczewski, P., & Spigset, O., (2023) Transfer of cetirizine/levocetirizine into human breast milk and estimation of drug exposure to infants through breastfeeding – a human lactation study from the ConcePTION project, Basic & Clinical Pharmacology & Toxicology, 9 October 2023, DOI: 10.1111/bcpt.13948

Bluett-Duncan, M., Astill, D., Charbak, R., Clayton-Smith, J., Cole, S., Cook, P.A., Cozens, J., Keely, K., Morris, J., Mukherjee, R., Murphy, E., Turnpenny, P., Williams, J., Wood, A.G., Yates, L.M., Bromley R.L., Neurodevelopmental outcomes in children and adults with Fetal Valproate Spectrum Disorder: A contribution from the ConcePTION project, Neurotoxicology and Teratology, Volume 100, November–December 2023, 107292, DOI: 10.1016/j.ntt.2023.107292

Cardoso, E., Montford, A., Ferreira, E., Norgeng, H., Winterfeld, U., Allegaert, K., Gandia, P., Guidi, M., & Panchaud, A. (2023) Maternal drugs and breastfeeding: Risk assessment from pharmacokinetics to safety evidence – A contribution from the ConcePTION project, Therapies 78(2), DOI: 10.1016/j.therap.2023.01.008

Monfort A, Cardoso E, Eap CB, Fischer Fumeaux CJ, Graz MB, Morisod Harari M, Weisskopf E, Gandia P, Allegaert K, Nordeng H, Hascoët J-M, Claris O, Epiney M, Csajka C, Guidi M, Ferreira E and Panchaud A (2023) Infant exposure to Fluvoxamine through placenta and human milk: a case series – A contribution from the ConcePTION project. Frontiers in Psychiatry 14:1167870. doi: 10.3389/fpsyt.2023.1167870

van Rijt-Weetink, Y.R.J., Chamani, K., Egberts, A.C.G., van Hunsel, F.P.A.M., Lewis D.J., Yates, L.M., Winterfeld, U., van Puijenbroek, E.P. (2023) Elements to assess the quality of information of case reports in pregnancy pharmacovigilance data—a ConcePTION project, Frontiers in Drug Safety and Regulation 3, DOI: 10.3389/fdsfr.2023.1187888

Hollestelle, M.J., van der Graaf, R., Sturkenboom, M.C. & van Delden J.JM. (2023) Stimulating solidarity to improve knowledge on medications used during pregnancy, BMC Med Ethics 24(44), DOI 10.1186/s12910-023-00924-x

Cardoso, E., Guidi, M., Nauwelaerts, N., Nordeng, H., Teil, M., Allegaert, K., Smits, A., Gandia, P., Edginton, A., Ito, S., Annaert, P., & Panchaud, A. (2023) Safety of medicines during breastfeeding – from case report to modeling: a contribution from the ConcePTION project, Expert Opinion on Drug Metabolism & Toxicology, DOI: 10.1080/17425255.2023.2221847

Bromley R. L., Bickle Graz M., Bluett-Duncan M., Chambers C., Damkier P., Dietrich K., Dolk H., Grant K., Mattson S., Meador K. J., Nordeng H., Oberlander T. F., Ornoy A., Revet A., Richardson J., Rovet J., Schuler-Faccini L., Smearman E., Simms V., Vorhees C., Wide K., Wood A., Yates L., Ystrom E., Supraja T. A., Adams J. (2023) Expert consensus on neurodevelopmental outcomes in pregnancy pharmacovigilance studies, Frontiers in Pharmacology 14, https://doi.org/10.3389/fphar.2023.1094698

Armoudjian, Y., Lin, A., Lammens, B., Van Daele, J., Annaert, P. (2023) Sensitive and rapid method for the quantitation of amoxicillin in minipig plasma and milk by LC-MS/MS: A contribution from the IMI ConcePTION project, Journal of Pharmacological and Toxicological Methods,107264, https://doi.org/10.1016/j.vascn.2023.107264.

Nauwelaerts, N., Macente, J., Deferm, N., Bonan, R.H., Huang, M-C., Van Neste, M., Bibi, D., Badee, J., Martins, F.S., Smits, A., Allegaert, K., Bouillon, T., Annaert, P. (2023) Generic Workflow to Predict Medicine Concentrations in Human Milk Using Physiologically-Based Pharmacokinetic (PBPK) Modelling—A Contribution from the ConcePTION Project. Pharmaceutics. 15(5):1469. https://doi.org/10.3390/pharmaceutics15051469

Jordan, S., Komninou, S., Lopez Leon, S. (2023), Where are the data linking infant outcomes, breastfeeding and medicine exposure? A systematic scoping review. PLOS ONE 18(4): e0284128. https://doi.org/10.1371/journal.pone.0284128

Richardson, J.L., Moore, A., Bromley, R.L. et al. (2023)  Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project. Drug Safety. https://doi.org/10.1007/s40264-023-01291-7 Epub 2023 Mar 28

Swertz, M., van Enckevort, E., Oliveira, J.L., Fortier, I., Bergeron, J., Thurin, N.H., Hyde, E., Pahoueshnja, R., Sturkenboom, M., Cunnington, M., Nybo Andersen, A-M., Marcon, Y., Gonçalves, G., Gini, R. (2022), Towards an Interoperable Ecosystem of Research Cohort and Real-world Data Catalogues Enabling Multi-center Studies, Yearb Med Inform, 2022:Aug;31(1):262-272. doi: 10.1055/s-0042-1742522. Epub 2022 Dec 4.

Jordan, S., Jones, E., Komninou, S., Loane, M., & Damase-Michel, C. (2022), Families need support to reduce the risk of adverse drug reactions from breastfeeding, Pharmaceutical Journal, Editorial, 7 November 2022

Given, J., Bromley, R. L., Coste, F., Lopez-Leon, S., & Loane, M. (2022), An inventory of European data sources to support pharmacoepidemiologic research on neurodevelopmental outcomes in children following medication exposure in pregnancy: A contribution from the ConcePTION project. PLoS ONE, 17(10): e0275979. https://doi.org/10.1371/journal.pone.0275979

Jordan, S., Bromley, R., Damase-Michel, C., Given, J., Komninou, S., Loane, M., Marfell, N., & Dolk, H. (2022). Breastfeeding, pregnancy, medicines, neurodevelopment, and population databases: the information desert. International Breastfeeding Journal, vol 17(55). https://doi.org/10.1186/s13006-022-00494-5

Roque Pereira, L., Durán, C.E., Layton, D., Poulentzas, G., Lalagkas, P-N., Kontogiorgis, C., & Sturkenboom, M. (2022). A Landscape Analysis of Post-Marketing Studies Registered in the EU PAS Register and ClinicalTrials.gov Focusing on Pregnancy Outcomes or Breastfeeding Effects: A Contribution from the ConcePTION Project. Drug Safety, 45, 333-344. https://doi.org/10.1007/s40264-022-01154-7

Wegler, C., Saleh, A., Lindqvist, A., Nordeng, H., Smeraglia, J., Baranczewski, B. (2022). Simple and rapid quantification of cetirizine, venlafaxine, and O-desmethylvenlafaxine in human breast milk, and metformin in human milk and plasma with UHPLC-MS/MS. Journal of Chromatography B, vol 1205. https://doi.org/10.1016/j.jchromb.2022.123340

Nauwelaerts, N., Ceulemans, M., Deferm, N., Eerdekens, A., Lammens, B., Armoudjian, Y., Van Calsteren, K., Allegaert, K., de Vries, L., Annaert, P., Smits, A. (2022). Case Report: Bosentan and Sildenafil Exposure in Human Milk A contribution from the ConcePTION project. Frontiers in Pharmacology, vol 13. https://doi.org/10.3389/fphar.2022.881084

Hollestelle, M.J., van der Graaf, R., Hartman, S.D., Sturkenboom, M., van Delden, J. (2022). A Learning Healthcare System for pregnant and breastfeeding women: what do women during preconception, pregnancy, and nursing think? – A qualitative study. BMC Pregnancy and Childbirth, vol 22(334). https://doi.org/10.1186/s12884-022-04675-2

Thurin, N.H., Pajouheshnia, R., Roberto, G., Dodd C., Hyeraci, G., Bartolini, C., Paoletti, O., Nordeng, H., Wallach-Kildemoes, H., Ehrenstein, V., Dudukina, E., MacDonald, T., De Paoli, G., Loane, M., Damase-Michel, C., Beau, A-B., Droz-Perroteau, C., Lassalle, R., Bergman, J., … Gini, R. (2021). From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding. Clinical Pharmacology & Therapeutics, vol 2022:111(1), 321-331. https://doi.org/10.1002/cpt.2476

Lewis, D.J., Yates, L., van Puijenbroek, E., Alexe, A. (2021). A framework for evidence of the safety of medicines in pregnancy and breastfeeding [Letter to the editor]. BMJ, 21 October 2021, https://www.bmj.com/content/375/bmj.n2377/rr-1

Bernardini, C., La Mantia, D., Salaroli, R., Zannoni, A., Nauwelaerts, N., Deferm, N., Ventrella, D., Bacci, M.L., Sarli, G., Bouisset-Leonard, M., Annaert, P., Forni, M. (2021). Development of a Pig Mammary Epithelial Cell Culture Model as a Non-Clinical Tool for Studying Epithelial Barrier — A Contribution from the IMI-ConcePTION Project. Animals, vol 11(7). https://doi.org/10.3390/ani11072012

Nörby, U., Noël-Cuppers, B., Hristoskova, S., Desai, M., Härmark, L., Steel, M., El-Haddad, C., Douarin, L. (2021). Online information discrepancies regarding safety of medicine use during pregnancy and lactation: an IMI ConcePTION study. Expert Opinion on Drug Safety, vol 20(9), 1117-1124. https://doi.org/10.1080/14740338.2021.1935865

Dudman, D.C., Tauqueer, F., Kaur, M., Ritchey, M.E., Li, H., Lopez-Leon, S. (2022). A systematic review and meta-analyses on the prevalence of pregnancy outcomes in migraine treated patients: a contribution from the IMI2 ConcePTION project. Journal of Neurology, vol 269, 742-749. https://doi.org/10.1007/s00415-021-10534-5

Ventrella, D., Ashkenazi, N., Elmi, A., Allegaert, K., Aniballi, C., DeLise, A., Devine, P.J., Smits, A., Steiner, L., Forni, M., Bouisset-Leonard, M., Bacci, M.L. (2021). Animal Models for In Vivo Lactation Studies: Anatomy, Physiology and Milk Compositions in the Most Used Non-Clinical Species: A Contribution from the ConcePTION Project. Animals, 11(3), 714; https://doi.org/10.3390/ani11030714

Nauwelaerts, N., Deferm, N., Smits, A., Bernardini, C., Lammens, B., Gandia, P., Panchaud , A., Nordeng, H., Bacci, M.L., Forni, M., Ventrella, D., Van Calsteren, K., DeLise, A., Huys, I., Bouisset-Leonard, M., Allegaert, K., Annaert, P. (2021). A comprehensive review on non-clinical methods to study transfer of medication into breast milk – A contribution from the ConcePTION project. Biomedicine & Pharmacotherapy, vol 136, article 111038. https://doi.org/10.1016/j.biopha.2020.111038

Lopez-Leon, S., Geissbühler, Y., Sabidó, M., Turkson, M., Wahlich, C., Morris, J.K. (2020). A systematic review and meta-analyses of pregnancy and fetal outcomes in women with multiple sclerosis: a contribution from the IMI2 ConcePTION project. Journal of Neurology, vol 267, 2721–2731. https://doi.org/10.1007/s00415-020-09913-1