- Renske M.T. ten Ham, Anke M. Hövels, Olaf H. Klungel ,Hubert G.M. Leufkens, Andre W. Broekmans, and Jarno Hoekman. Development and Regulation of Gene and Cell-Based Therapies in Europe: A Quantification and Reflection. Trends in Pharmacological Sciences, Volume 41, Issue 2, 67-71. February 2020.
- Christine C. Gispen‐de Wied, Just Weemers, Wouter Boon, Peter G.M. Mol, Pieter Stolk. Future of the drug label: Perspectives from a multistakeholder dialogue. BJCP. July 18 2019
- Klein K., Scholl J.H.G., De Bruin M.L., Van Puijenbroek E.P., Leufkens H.G.M., Stolk P. When More Is Less: An Exploratory Study of the Precautionary Reporting Bias and Its Impact on Safety Signal Detection. Clin Pharmacol Ther. Sep 15 2017
- Hussaarts L., Mühlebach S., Shah VP., McNeil S., Borchard G., Flühmann B., Weinstein V., Neervannan S., Griffiths E., Jiang W., Wolff-Holz E., Crommelin DJA., de Vlieger JSB. Equivalence of complex drug products: advances in and challenges for current regulatory frameworks. Ann N Y Acad Sci Apr 26. [Epub ahead of print] (2017)
- Klein, K., Scholl, J.H., Vermeer, N.S., Broekmans, A.W., Van Puijenbroek, E.P., De Bruin, M.L., Stolk, P. Traceability of Biologics in The Netherlands: An Analysis of Information-Recording Systems in Clinical Practice and Spontaneous ADR Reports. Drug Safety 39, 185-192. (2016)
- Crommelin, D. J., & de Vlieger, J. S. (Eds.). Non-biological complex drugs: the science and the regulatory landscape 20. Springer. (2015)
- Klein, K., De Bruin, M.L., Broekmans, A.W., Stolk, P. Classification of Recombinant Biologics in the EU: Divergence Between National Pharmacovigilance Centers. BioDrugs 29, 373-379. (2015)
- Schellekens, H., Stegemann, S., Weinstein, V., de Vlieger, J. S., Flühmann, B., Mühlebach, S., & Crommelin, D. J. How to regulate nonbiological complex drugs (NBCD) and their follow-on versions: points to consider. The AAPS journal 16, 15-21. (2014)
- Escher. Improving the EU system for the marketing authorization of medicines - Learning from regulatory practice. Leiden: Escher – The TI Pharma Platform for Regulatory Innovation. (2014) [PDF file]
A full list of publications on non-biological complex drugs co-authored by our team can be found here.
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