Data driven evaluation of healthy volunteer characteristics at screening for phase I clinical trials to inform on study design and optimize screening processes

Autor: Annemie Deiteren, Erwin Coenen, Sabine Lenders, Peter Verwilst, Erik Mannaert, Freya Rasschaert

Publikováno v: Clinical and Translational Science, Vol 14, Iss 6, Pp 2450-2460 (2021)

Abstract Protocols for clinical trials describe inclusion and exclusion criteria based on general and compound‐specific considerations to ensure subject safety and data quality. In phase I clinical trials, healthy volunteers (HVs) are screened agai

Externí odkaz: https://doaj.org/article/4235eb3060a14b7e8e5f2d52ef5832b6

In Vitro Evaluation of Poly(lactide-co-glycolide) In Situ Forming Gels for Bedaquiline Fumarate Salt and Pharmacokinetics Following Subcutaneous Injection in Rats

Autor: Sandy Van Hemelryck, Rani Wens, Hannelore van Poppel, Milou Luijks, Koosha Shahidi, Marcin Marczak, Ariane Kahnt, René Holm, Erik Mannaert, Peter Langguth

Publikováno v: Pharmaceutics, Vol 13, Iss 8, p 1231 (2021)

This study evaluated in vitro and in vivo drug release of bedaquiline from in situ forming gels (ISGs) containing 200 mg eq./g bedaquiline fumarate salt prepared with four different grades of poly(d,l-lactide) (PDLLA) or poly(d,l-lactide-co-glycolide

Externí odkaz: https://doaj.org/article/2a963148dce44c2a8f2e1c01e20930bf

In Vitro Evaluation of Poly(lactide-co-glycolide) In Situ Forming Gels for Bedaquiline Fumarate Salt and Pharmacokinetics Following Subcutaneous Injection in Rats

Autor: René Holm, Erik Mannaert, Rani Wens, A. Kahnt, Sandy Van Hemelryck, Milou Luijks, Hannelore van Poppel, Marcin Marczak, Peter Langguth, Koosha Shahidi

Publikováno v: Pharmaceutics
Volume 13
Issue 8
Pharmaceutics, Vol 13, Iss 1231, p 1231 (2021)
Van Hemelryck, S, Wens, R, van Poppel, H, Luijks, M, Shahidi, K, Marczak, M, Kahnt, A, Holm, R, Mannaert, E & Langguth, P 2021, ' In vitro evaluation of poly(Lactide-co-glycolide) in situ forming gels for bedaquiline fumarate salt and pharmacokinetics following subcutaneous injection in rats ', Pharmaceutics, vol. 13, no. 8, 1231 . https://doi.org/10.3390/pharmaceutics13081231

This study evaluated in vitro and in vivo drug release of bedaquiline from in situ forming gels (ISGs) containing 200 mg eq./g bedaquiline fumarate salt prepared with four different grades of poly(d,l-lactide) (PDLLA) or poly(d,l-lactide-co-glycolide

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a9c28ce7bb7297b9b549960c10e5f448

A survey on IVIVC/IVIVR development in the pharmaceutical industry – Past experience and current perspectives

Autor: John R. Crison, Martin Mueller-Zsigmondy, Talia Flanagan, A. Van Peer, Mark McAllister, Uwe Muenster, Peter Timmins, Erik Mannaert, Jeike Biewenga, René Holm, Stefania Beato, S. Page, Stefaan Rossenu, Peter Langguth, Alan F. Parr, Filippos Kesisoglou, Mai Anh Nguyen, R. Li, An Vermeulen, Krista Ojala, Marcus E. Brewster

Publikováno v: European Journal of Pharmaceutical Sciences. 102:1-13

The present work aimed to describe the current status of IVIVC/IVIVR development in the pharmaceutical industry, focusing on the use and perception of specific approaches as well as successful and failed case studies. Two questionnaires have been dis

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6c33dedd043afdd6fbb8d10c77d2cdf0
https://doi.org/10.1016/j.ejps.2017.02.029

Stable isotope-labelled intravenous microdose for absolute bioavailability and effect of grapefruit juice on ibrutinib in healthy adults

Autor: Juthamas Sukbuntherng, James Jiao, Donna Skee, Joseph Murphy, Jan de Jong, Ronald de Vries, Loeckie de Zwart, Erik Mannaert, Maarten Vliegen, Jan Snoeys, Johan W. Smit, Peter Hellemans

Publikováno v: British Journal of Clinical Pharmacology. 81:235-245

Aims Ibrutinib, an inhibitor of Bruton's tyrosine kinase, is used in the treatment of mantle cell lymphoma or chronic lymphocytic leukaemia. Ibrutinib undergoes extensive rapid oxidative metabolism mediated by cytochrome P450 3A both at the level of

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::bff9427ba9481af157e8d11d97e01421
https://doi.org/10.1111/bcp.12787