In Vitro Biopredictive Methods: A Workshop Summary Report

Autor: Erik Sjögren, James Butler, Vidula Kolhatkar, Xavier Pepin, Lynne S. Taylor, Andrew Babiskin, Sandra Suarez-Sharp, Paul Seo, Jennifer B. Dressman, Christer Tannergren, André Dallmann, Xinyuan Zhang, Poonam Delvadia, Edmund Kostewicz, Yang Zhao, Amitava Mitra, Filippos Kesisoglou, Mirko Koziolek, Neil Parrott

Publikováno v: Journal of Pharmaceutical Sciences. 110:567-583

This workshop report summarizes the proceedings of Day 1 of a three-day workshop on “Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls”. Physiologica

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https://doi.org/10.1016/j.xphs.2020.09.021

Physiological Considerations and In Vitro Strategies for Evaluating the Influence of Food on Drug Release from Extended-Release Formulations

Autor: Maria Vertzoni, Mirko Koziolek, Edmund Kostewicz

Publikováno v: AAPS PharmSciTech. 19:2885-2897

Food effects on oral drug bioavailability are a consequence of the complex interplay between drug, formulation and human gastrointestinal (GI) physiology. Accordingly, the prediction of the direction and the extent of food effects is often difficult.

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https://doi.org/10.1208/s12249-018-1159-0

IMI – Oral biopharmaceutics tools project – Evaluation of bottom-up PBPK prediction success part 2: An introduction to the simulation exercise and overview of results

Autor: Richard Lloyd, Leon Aarons, Mark McAllister, Amitava Mitra, Chester Costales, Timo Korjamo, Maria Hammarberg, Helena Thörn, Carole Shardlow, Jussi Malkki, Adam S. Darwich, Tycho Heimbach, Achiel Van Peer, James M. Mullin, Jennifer B. Dressman, Johanna Laru, Dónal Murphy, Handan He, Jian Lin, Irina Mishenzon, Ke X. Szeto, Mei Wong, Peter Langguth, Bertil Abrahamsson, Carolin Hoft, Fan Wu, Mohammed Yasin, Olivier Nicolas, Manthena V.S. Varma, Alison Margolskee, Christer Tannergren, Edmund Kostewicz, Yan Pang, Shriram M. Pathak, Johanna Tuunainen, Constanze Hilgendorf, Sari Pappinen, Viera Lukacova, Charles J. Rotter, Jan Bevernage, Sweta Modi, Sergej Ramusovic, Simone Hansmann, Mai Anh Nguyen, Amin Rostami-Hodjegan, Eva Huehn, Michael B. Bolger, Jonathan Brown, Loic Laplanche, Christine Xu, Eva Karlsson, Sara Carlert, Pernilla Johansson, Florent Mazuir, Jeike Biewenga, Xavier Pepin, Hans Lennernäs, Aleksandra Galetin

Publikováno v: Margolskee, A, Darwich, A, Aarons, L, Galetin, A, Rostami-Hochaghan, A, Carlert, S, Hammarberg, M, Hilgendorf, C, Johansson, P, Karlsson, E, Murphy, D, Tannergren, C, Thorn, H, Yasin, M, Mazuir, F, Nicolas, O, Ramusovic, S, Xu, C, Pathak, S, Korjamo, T, Laru, J, Malkki, J, Pappinen, S, Tuunainen, J, Dressman, J, Hansmann, S, Kostewicz, E, He, H, Heimbach, T, Wu, F, Hoft, C, Laplanche, L, Pang, Y, Bolger, M B, Huehn, E, Lukacova, V, Mullin, J M, Szeto, K X, Costales, C, Lin, J, McAllister, M, Modi, S, Rotter, C, Varma, M, Wong, M, Mitra, A, Bevernage, J, Biewenga, J, Van Peer, A, Lloyd, R, Shardlow, C, Langguth, P, Mishenzon, I, Nguyen, M A, Brown, J, Lennernas, H & Abrahamsson, B 2016, ' IMI – Oral Biopharmaceutics Tools project – Evaluation of Bottom-up PBPK Prediction Success Part 2: An Introduction to the Simulation Exercise and Overview of Results ', European Journal of Pharmaceutical Sciences . https://doi.org/10.1016/j.ejps.2016.10.036

Orally administered drugs are subject to a number of barriers impacting bioavailability (Foral), causing challenges during drug and formulation development. Physiologically-based pharmacokinetic (PBPK) modelling can help during drug and formulation d

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https://doi.org/10.1016/j.ejps.2016.10.036

In vitro models for the prediction of in vivo performance of oral dosage forms: Recent progress from partnership through the IMI OrBiTo collaboration

Autor: Cord J. Andreas, Christos Reppas, Patrick Augustijns, Filippos Kesisoglou, Mans Minekus, Kerstin Julia Schaefer, James Butler, Mirko Koziolek, Philipp Jedamzik, Bart Hens, Edmund Kostewicz, Masoud Jamei, James Mann, Joachim Brouwers, Jennifer B. Dressman, Philippe Berben, Maria Vertzoni, Ronald Schilderink, Peter Langguth, Werner Weitschies, Anette Müllertz, Mark McAllister

Publikováno v: European Journal of Pharmaceutics and Biopharmaceutics, 136, 70-83
Butler, J, Hens, B, Vertzoni, M, Brouwers, J, Berben, P, Dressman, J, Andreas, C J, Schaefer, K J, Mann, J, McAllister, M, Jamei, M, Kostewicz, E, Kesisoglou, F, Langguth, P, Minekus, M, Mullertz, A, Schilderink, R, Koziolek, M, Jedamzik, P, Weitschies, W, Reppas, C & Augustijns, P 2019, ' In vitro models for the prediction of in vivo performance of oral dosage forms: Recent progress from partnership through the IMI OrBiTo collaboration ', European Journal of Pharmaceutics and Biopharmaceutics, vol. 136, pp. 70-83 . https://doi.org/10.1016/j.ejpb.2018.12.010

The availability of in vitro tools that are constructed on the basis of a detailed knowledge of key aspects of gastrointestinal (GI) physiology and their impact on formulation performance and subsequent drug release behaviour is fundamental to the su

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http://resolver.tudelft.nl/uuid:6d550c74-1751-4915-ba01-df580dc8a211

In vitro methods to assess drug precipitation in the fasted small intestine - a PEARRL review

Autor: Chara Litou, Christos Reppas, Karl J. Box, Jennifer B. Dressman, Patrick J O'Dwyer, Martin Kuentz, Edmund Kostewicz

Publikováno v: Journal of Pharmacy and Pharmacology

Objectives Drug precipitation in vivo poses a significant challenge for the pharmaceutical industry. During the drug development process, the impact of drug supersaturation or precipitation on the in vivo behaviour of drug products is evaluated with

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fdd1225be988c3f894c5212e668b69fc