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Zahari Vinarov, Mohammad Abdallah, José A. G. Agúndez, Karel Allegaert, Abdul W. Basit, Marlies Braeckmans, Jens Ceulemans, Maura Corsetti, Brendan T. Griffin, Michael F. Grimm and 15 more
The absorption of oral drugs is frequently plagued by significant variability with potentially serious therapeutic consequences. The source of variability can be traced back to interindividual variability in physiology, differences in special populations (age- and disease-dependent), drug and formulation properties, or food-drug interactions. Clinical evidence for the impact of some of these factors on drug pharmacokinetic variability is mounting: e.g. gastric pH and emptying time, small intestinal fluid properties, differences in pediatrics and the elderly, and surgical changes in gastrointestinal anatomy. However, the link of colonic factors variability (transit time, fluid composition, microbiome), sex differences (male vs. female) and gut-related diseases (chronic constipation, anorexia and cachexia) to drug absorption variability has not been firmly established yet. At the same time, a way to decrease oral drug pharmacokinetic variability is provided by the pharmaceutical industry: clinical evidence suggests that formulation approaches employed during drug development can decrease the variability in oral exposure. This review outlines the main drivers of oral drug exposure variability and potential approaches to overcome them, while highlighting existing knowledge gaps and guiding future studies in this area.
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Vinarov, Z., Abdallah, M., Agúndez, J. A. G., Allegaert, K., Basit, A. W., Braeckmans, M., Ceulemans, J., Corsetti, M., Griffin, B. T., Grimm, M. F., Keszthelyi, D., Koziolek, M., Madla, C. M., Matthys, C., McCoubrey, L. E., Mitra, A., Reppas, C. I., Stappaerts, J., Steenackers, N., … Augustijns, P. (2021). Impact of gastrointestinal tract variability on oral drug absorption and pharmacokinetics: An UNGAP review. European Journal of Pharmaceutical Sciences, 162, 105812. https://doi.org/10.1016/j.ejps.2021.105812
Vinarov, Zahari, et al. "Impact of gastrointestinal tract variability on oral drug absorption and pharmacokinetics: An UNGAP review." European Journal of Pharmaceutical Sciences, vol. 162, 2021, pp. 105812, https://doi.org/10.1016/j.ejps.2021.105812.
Vinarov, Zahari, Mohammad Abdallah, José A. G. Agúndez, Karel Allegaert, Abdul W. Basit, Marlies Braeckmans, Jens Ceulemans, et al. "Impact of gastrointestinal tract variability on oral drug absorption and pharmacokinetics: An UNGAP review." European Journal of Pharmaceutical Sciences 162 (2021): 105812. https://doi.org/10.1016/j.ejps.2021.105812.
Vinarov Z., Abdallah M., Agúndez J. A. G. [и др.] Impact of gastrointestinal tract variability on oral drug absorption and pharmacokinetics: An UNGAP review // European Journal of Pharmaceutical Sciences. — 2021. — Vol. 162. — P. 105812. — URL: https://doi.org/10.1016/j.ejps.2021.105812
@article{vinarov2021impact,
title = {{Impact of gastrointestinal tract variability on oral drug absorption and pharmacokinetics: An UNGAP review}},
author = {Zahari Vinarov and Mohammad Abdallah and José A. G. Agúndez and Karel Allegaert and Abdul W. Basit and Marlies Braeckmans and Jens Ceulemans and Maura Corsetti and Brendan T. Griffin and Michael F. Grimm and Dániel Keszthelyi and Mirko Koziolek and Christine M. Madla and Christophe Matthys and Laura E. McCoubrey and Amitava Mitra and Christos I. Reppas and Jef Stappaerts and Nele Steenackers and Natalie L. Trevaskis and Tim Vanuytsel and Maria Vertzoni and Werner Weitschies and CLIVE G. WILSON and Patrick Augustijns},
journal = {European Journal of Pharmaceutical Sciences},
year = {2021},
volume = {162},
pages = {105812},
doi = {10.1016/j.ejps.2021.105812},
url = {https://doi.org/10.1016/j.ejps.2021.105812}
}TY - JOUR AU - Vinarov, Zahari AU - Abdallah, Mohammad AU - Agúndez, José A. G. AU - Allegaert, Karel AU - Basit, Abdul W. AU - Braeckmans, Marlies AU - Ceulemans, Jens AU - Corsetti, Maura AU - Griffin, Brendan T. AU - Grimm, Michael F. AU - Keszthelyi, Dániel AU - Koziolek, Mirko AU - Madla, Christine M. AU - Matthys, Christophe AU - McCoubrey, Laura E. AU - Mitra, Amitava AU - Reppas, Christos I. AU - Stappaerts, Jef AU - Steenackers, Nele AU - Trevaskis, Natalie L. AU - Vanuytsel, Tim AU - Vertzoni, Maria AU - Weitschies, Werner AU - WILSON, CLIVE G. AU - Augustijns, Patrick TI - Impact of gastrointestinal tract variability on oral drug absorption and pharmacokinetics: An UNGAP review JO - European Journal of Pharmaceutical Sciences VL - 162 SP - 105812 PY - 2021 DA - 2021/03/20 DO - 10.1016/j.ejps.2021.105812 UR - https://doi.org/10.1016/j.ejps.2021.105812 ER -
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