Evaluation of Companion Diagnostics in Scientific Advice and Drug Marketing Authorization Applications by the European Medicines Agency

por Maliepaard, Marc, Nibi, Priscilla, Nibi, Gabrièlla, Pasmooij, Anna M. G.
Publicado 2022

The Use of Remote Monitoring Technologies: A Review of Recent Regulatory Scientific Advices, Qualification Opinions, and Qualification Advices Issued by the European Medicines Agen...

por Dekker, Marieke J. H. J., Stolk, Pieter, Pasmooij, Anna M. G.
Publicado 2021

Revertant Mosaicism in Genodermatoses: Natural Gene Therapy Right before Your Eyes

por van den Akker, Peter C., Bolling, Maria C., Pasmooij, Anna M. G.
Publicado 2022

Orphan Medicinal Products for the Treatment of Pancreatic Cancer: Lessons Learned From Two Decades of Orphan Designation

por Mulder, Jorn, van Rossum, Tobias, Mariz, Segundo, Magrelli, Armando, de Boer, Anthonius, Pasmooij, Anna M. G., Stoyanova-Beninska, Violeta
Publicado 2021

Medication Adherence Measurement Methods in Registration Trials Supporting the Approval of New Medicines: A Cross‐Sectional Analysis of Centralized Procedures in the European Union...

por Mantila, Katerina M., Pasmooij, Anna M.G., Hallgreen, Christine Erikstrup, Mol, Peter G.M., van Boven, Job F.M.
Publicado 2022

A "late-but-fitter revertant cell" explains the high frequency of revertant mosaicism in epidermolysis bullosa

por van den Akker, Peter C., Pasmooij, Anna M. G., Joenje, Hans, Hofstra, Robert M. W., te Meerman, Gerard J., Jonkman, Marcel F.
Publicado 2018

A Comparison of Post-marketing Measures Imposed by Regulatory Agencies to Confirm the Tissue-Agnostic Approach

por Mulder, Jorn, van Stuijvenberg, Odile C., van Hennik, Paula B., Voest, Emile E., Pasmooij, Anna M. G., Stoyanova-Beninska, Violeta, de Boer, Anthonius
Publicado 2022

Murine type VII collagen distorts outcome in human skin graft mouse model for dystrophic epidermolysis bullosa

por Bremer, Jeroen, Kramer, Duco, Eichhorn, Daryll S., Gostyński, Antoni, Diercks, Gilles F. H., Jonkman, Marcel F., van den Akker, Peter C., Pasmooij, Anna M. G.
Publicado 2018

Translating Academic Drug Discovery Into Clinical Development: A Survey of the Awareness of Regulatory Support and Requirements Among Stakeholders in Europe

por Kallio, Marko J., Starokozhko, Viktoriia, Agricola, Eleonora, Burggraf, Manja, Heß, Anne, Ballensiefen, Wolfgang, Löbker, Wiebke, Nuevo, Yoana, Pasmooij, Anna M.G., Mol, Peter G.M.
Publicado 2022

Access to medicines for rare diseases: A European regulatory roadmap for academia

por Rosenberg, Noa, van den Berg, Sibren, Stolwijk, Nina N., Jacobs, Bart A. W., Post, Hendrika C., Pasmooij, Anna M. G., de Visser, Saco J., Hollak, Carla E. M.
Publicado 2023

Extension of Indication for Authorised Oncology Products in the European Union: A Joint Effort of Multiple Stakeholders

por Mulder, Jorn, Verjans, Robin, Verbaanderd, Ciska, Pean, Elias, Weemers, Just, Leufkens, Hubert G. M., Pignatti, Francesco, de Boer, Anthonius, Voest, Emile E., Stoyanova-Beninska, Violeta V., Pasmooij, Anna M. G.
Publicado 2021

Natural Exon Skipping Sets the Stage for Exon Skipping as Therapy for Dystrophic Epidermolysis Bullosa

por Bremer, Jeroen, van der Heijden, Elisabeth H., Eichhorn, Daryll S., Meijer, Rowdy, Lemmink, Henny H., Scheffer, Hans, Sinke, Richard J., Jonkman, Marcel F., Pasmooij, Anna M.G., Van den Akker, Peter C.
Publicado 2019

High-efficiency RNA-based reprogramming of human primary fibroblasts

por Kogut, Igor, McCarthy, Sandra M., Pavlova, Maryna, Astling, David P., Chen, Xiaomi, Jakimenko, Ana, Jones, Kenneth L., Getahun, Andrew, Cambier, John C., Pasmooij, Anna M. G., Jonkman, Marcel F., Roop, Dennis R., Bilousova, Ganna
Publicado 2018

Therapeutic Prospects of Exon Skipping for Epidermolysis Bullosa

por Vermeer, Franciscus C., Bremer, Jeroen, Sietsma, Robert J., Sandilands, Aileen, Hickerson, Robyn P., Bolling, Marieke C., Pasmooij, Anna M.G., Lemmink, Henny H., Swertz, Morris A., Knoers, Nine V.A.M., van der Velde, K. Joeri, van den Akker, Peter C.
Publicado 2021

Ethical challenges of using remote monitoring technologies for clinical research: A case study of the role of local research ethics committees in the RADAR-AD study

por Muurling, Marijn, Pasmooij, Anna M. G., Koychev, Ivan, Roik, Dora, Froelich, Lutz, Schwertner, Emilia, Religa, Dorota, Abdelnour, Carla, Boada, Mercè, Almici, Monica, Galluzzi, Samantha, Cardoso, Sandra, de Mendonça, Alexandre, Owens, Andrew P., Kuruppu, Sajini, Gjestsen, Martha Therese, Lazarou, Ioulietta, Gkioka, Mara, Tsolaki, Magda, Diaz, Ana, Gove, Dianne, Visser, Pieter Jelle, Aarsland, Dag, Lucivero, Federica, de Boer, Casper
Publicado 2023

Correction: Ethical challenges of using remote monitoring technologies for clinical research: A case study of the role of local research ethics committees in the RADAR-AD study

por Muurling, Marijn, Pasmooij, Anna M. G., Koychev, Ivan, Roik, Dora, Froelich, Lutz, Schwertner, Emilia, Religa, Dorota, Abdelnour, Carla, Boada, Mercè, Almici, Monica, Galluzzi, Samantha, Cardoso, Sandra, de Mendonça, Alexandre, Owens, Andrew P., Kuruppu, Sajini, Gjestsen, Martha Therese, Lazarou, Ioulietta, Gkioka, Mara, Tsolaki, Magda, Diaz, Ana, Gove, Dianne, Visser, Pieter Jelle, Aarsland, Dag, Lucivero, Federica, de Boer, Casper
Publicado 2023

Postapproval trials versus patient registries: comparability of advanced melanoma patients with brain metastases

por Ismail, Rawa K., Sikkes, Nienke O., Wouters, Michel W.J.M., Hilarius, Doranne L., Pasmooij, Anna M.G., van den Eertwegh, Alfonsus J.M., Aarts, Maureen J.B., van den Berkmortel, Franchette W.P.J., Boers-Sonderen, Marye J., de Groot, Jan Willem B., Haanen, John B.A.G., Hospers, Geke A.P., Kapiteijn, Ellen, Piersma, Djura, van Rijn, Roos S., Suijkerbuijk, Karijn P.M., ten Tije, Bert-Jan, van der Veldt, Astrid A.M., Vreugdenhil, Art, van Dartel, Maaike, de Boer, Anthonius
Publicado 2020