Search Results - "van Peer, Achiel"

From preclinical to human - prediction of oral absorption and drug-drug interaction potential using physiologically based pharmacokinetic (PBPK) modeling approach in an industrial setting: a workflow by using case example by Sinha, Vikash Kumar, Snoeys, Jan, Osselaer, Nancy Van, Peer, Achiel Van, Mackie, Claire, Heald, Donald

“…ABSTRACT Purpose A case example is presented in which the physiologically based modeling approach has been used to model the absorption of a lipophilic BCS…”
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In vivo methods for drug absorption – Comparative physiologies, model selection, correlations with in vitro methods (IVIVC), and applications for formulation/API/excipient characterization including food effects by Sjögren, Erik, Abrahamsson, Bertil, Augustijns, Patrick, Becker, Dieter, Bolger, Michael B., Brewster, Marcus, Brouwers, Joachim, Flanagan, Talia, Harwood, Matthew, Heinen, Christian, Holm, René, Juretschke, Hans-Paul, Kubbinga, Marlies, Lindahl, Anders, Lukacova, Viera, Münster, Uwe, Neuhoff, Sibylle, Nguyen, Mai Anh, Peer, Achiel van, Reppas, Christos, Hodjegan, Amin Rostami, Tannergren, Christer, Weitschies, Werner, Wilson, Clive, Zane, Patricia, Lennernäs, Hans, Langguth, Peter

“…[Display omitted] This review summarizes the current knowledge on anatomy and physiology of the human gastrointestinal tract in comparison with that of common…”
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Use of physiologically relevant biopharmaceutics tools within the pharmaceutical industry and in regulatory sciences: Where are we now and what are the gaps? by Flanagan, Talia, Van Peer, Achiel, Lindahl, Anders

“…Regulatory interactions are an important part of the drug development and licensing process. A survey on the use of biopharmaceutical tools for regulatory…”
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Pharmacokinetics of the novel antipsychotic agent risperidone and the prolactin response in healthy subjects by Huang, M L, Van Peer, A, Woestenborghs, R, De Coster, R, Heykants, J, Jansen, A A, Zylicz, Z, Visscher, H W, Jonkman, J H

“…The pharmacokinetics of a novel antipsychotic agent, risperidone, and the prolactin response were studied in 12 dextromethorphan-phenotyped healthy men after…”
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Physiology-Based IVIVE Predictions of Tramadol from in Vitro Metabolism Data by T’jollyn, Huybrecht, Snoeys, Jan, Colin, Pieter, Van Bocxlaer, Jan, Annaert, Pieter, Cuyckens, Filip, Vermeulen, An, Van Peer, Achiel, Allegaert, Karel, Mannens, Geert, Boussery, Koen

“…ABSTRACT Purpose To predict the tramadol in vivo pharmacokinetics in adults by using in vitro metabolism data and an in vitro - in vivo extrapolation…”
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Predicting Oral Clearance in Humans: How Close Can We Get with Allometry? by Sinha, Vikash K., De Buck, Stefan S., Fenu, Luca A., Smit, Johan W., Nijsen, Marjoleen, Gilissen, Ron A. H. J., Van Peer, Achiel, Lavrijsen, Karel, Mackie, Claire E.

“…Background Oral clearance (CL/F) is an important pharmacokinetic parameter and plays an important role in the selection of a safe and tolerable dose for…”
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Towards a Better Prediction of Peak Concentration, Volume of Distribution and Half-Life after Oral Drug Administration in Man, Using Allometry by Sinha, Vikash K., Vaarties, Karin, De Buck, Stefan S., Fenu, Luca. A., Nijsen, Marjoleen, Gilissen, Ron A. H. J., Sanderson, Wendy, Uytsel, Kelly Van, Hoeben, Eva, Peer, Achiel Van, Mackie, Claire E., Smit, Johan W.

“…Background: It is imperative that new drugs demonstrate adequate pharmacokinetic properties, allowing an optimal safety margin and convenient dosing regimens…”
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Including Information on the Therapeutic Window in Bioequivalence Acceptance by Jacobs, Tom, De Ridder, Filip, Rusch, Sarah, Van Peer, Achiel, Molenberghs, Geert, Bijnens, Luc

“…Purpose A novel bioequivalence limit is proposed taking into account the therapeutic window. Methods The therapeutic range is introduced as the ratios maximum…”
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Galantamine Population Pharmacokinetics in Patients with Alzheimer's Disease: Modeling and Simulations by Piotrovsky, Vladimir, Van Peer, Achiel, Van Osselaer, Nancy, Armstrong, Martin, Aerssens, Jeroen

“…Galantamine is a reversible, competitive inhibitor of acetylcholinesterase and an allosteric modulator of nicotinic acetylcholine receptors. It is cleared by…”
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Variability and Impact on Design of Bioequivalence Studies by Van Peer, Achiel

“…:  In 2008, the European Agency for the Evaluation of Medicinal Products released a draft guidance on the investigation of bioequivalence for immediate release…”
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The successes and failures of physiologically based pharmacokinetic modeling: there is room for improvement by Poggesi, Italo, Snoeys, Jan, Van Peer, Achiel

“…From the year 2000 onwards, physiologically based pharmacokinetic (PBPK) models in the field of drug research and development have been increasingly used. This…”
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Mechanistic Understanding of Brain Drug Disposition to Optimize the Selection of Potential Neurotherapeutics in Drug Discovery by Loryan, Irena, Sinha, Vikash, Mackie, Claire, Van Peer, Achiel, Drinkenburg, Wilhelmus, Vermeulen, An, Morrison, Denise, Monshouwer, Mario, Heald, Donald, Hammarlund-Udenaes, Margareta

“…ABSTRACT Purpose The current project was undertaken with the aim to propose and test an in-depth integrative analysis of neuropharmacokinetic (neuroPK)…”
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Physiologically-Based PK/PD Modelling of Therapeutic Macromolecules by Thygesen, Peter, Macheras, Panos, Van Peer, Achiel

“…Therapeutic proteins are a diverse class of drugs consisting of naturally occurring or modified proteins, and due to their size and physico-chemical…”
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Preclinical Bioavailability Strategy for Decisions on Clinical Drug Formulation Development: An In Depth Analysis by Van den Bergh, An, Van Hemelryck, Sandy, Bevernage, Jan, Van Peer, Achiel, Brewster, Marcus, Mackie, Claire, Mannaert, Erik

“…The aim of the presented retrospective analysis was to verify whether a previously proposed Janssen Biopharmaceutical Classification System (BCS)-like decision…”
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A model with separate hepato-portal compartment (first-pass model) : Fitting to plasma concentration-time profiles in humans by PIOTROVSKIJ, V, VAN PEER, A

“…To demonstrate the value of "first-pass" pharmacokinetic models (FPMs) in which the hepato-portal (HP) system is kinetically separated from the central…”
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Molecular Properties Determining Unbound Intracellular and Extracellular Brain Exposure of CNS Drug Candidates by Loryan, Irena, Sinha, Vikash, Mackie, Claire, Van Peer, Achiel, Drinkenburg, Wilhelmus H, Vermeulen, An, Heald, Donald, Hammarlund-Udenaes, Margareta, Wassvik, Carola M

“…In the present work we sought to gain a mechanistic understanding of the physicochemical properties that influence the transport of unbound drug across the…”
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IMI – Oral biopharmaceutics tools project – Evaluation of bottom-up PBPK prediction success part 3: Identifying gaps in system parameters by analysing In Silico performance across different compound classes by Darwich, Adam S., Margolskee, Alison, Pepin, Xavier, Aarons, Leon, Galetin, Aleksandra, Rostami-Hodjegan, Amin, Carlert, Sara, Hammarberg, Maria, Hilgendorf, Constanze, Johansson, Pernilla, Karlsson, Eva, Murphy, Dónal, Tannergren, Christer, Thörn, Helena, Yasin, Mohammed, Mazuir, Florent, Nicolas, Olivier, Ramusovic, Sergej, Xu, Christine, Pathak, Shriram M., Korjamo, Timo, Laru, Johanna, Malkki, Jussi, Pappinen, Sari, Tuunainen, Johanna, Dressman, Jennifer, Hansmann, Simone, Kostewicz, Edmund, He, Handan, Heimbach, Tycho, Wu, Fan, Hoft, Carolin, Pang, Yan, Bolger, Michael B., Huehn, Eva, Lukacova, Viera, Mullin, James M., Szeto, Ke X., Costales, Chester, Lin, Jian, McAllister, Mark, Modi, Sweta, Rotter, Charles, Varma, Manthena, Wong, Mei, Mitra, Amitava, Bevernage, Jan, Biewenga, Jeike, Van Peer, Achiel, Lloyd, Richard, Shardlow, Carole, Langguth, Peter, Mishenzon, Irina, Nguyen, Mai Anh, Brown, Jonathan, Lennernäs, Hans, Abrahamsson, Bertil

“…Three Physiologically Based Pharmacokinetic software packages (GI-Sim, Simcyp® Simulator, and GastroPlus™) were evaluated as part of the Innovative Medicine…”
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Physiologically Based Pharmacokinetic Predictions of Tramadol Exposure Throughout Pediatric Life: an Analysis of the Different Clearance Contributors with Emphasis on CYP2D6 Maturation by T’jollyn, Huybrecht, Snoeys, Jan, Vermeulen, An, Michelet, Robin, Cuyckens, Filip, Mannens, Geert, Van Peer, Achiel, Annaert, Pieter, Allegaert, Karel, Van Bocxlaer, Jan, Boussery, Koen

“…This paper focuses on the retrospective evaluation of physiologically based pharmacokinetic (PBPK) techniques used to mechanistically predict clearance…”
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Physiological red blood cell kinetic model to explain the apparent discrepancy between adenosine breakdown inhibition and nucleoside transporter occupancy of draflazine by Snoeck, E, Ver Donck, K, Jacqmin, P, Van Belle, H, Dupont, A G, Van Peer, A, Danhof, M

“…A physiological red blood cell (RBC) kinetic model is proposed for the adenosine (ADO) transport into erythrocytes and its subsequent intracellular deamination…”
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IMI – oral biopharmaceutics tools project – evaluation of bottom-up PBPK prediction success part 1: Characterisation of the OrBiTo database of compounds by Margolskee, Alison, Darwich, Adam S., Pepin, Xavier, Pathak, Shriram M., Bolger, Michael B., Aarons, Leon, Rostami-Hodjegan, Amin, Angstenberger, Jonas, Graf, Franziska, Laplanche, Loic, Müller, Thomas, Carlert, Sara, Daga, Pankaj, Murphy, Dónal, Tannergren, Christer, Yasin, Mohammed, Greschat-Schade, Susanne, Mück, Wolfgang, Muenster, Uwe, van der Mey, Dorina, Frank, Kerstin Julia, Lloyd, Richard, Adriaenssen, Lieve, Bevernage, Jan, De Zwart, Loeckie, Swerts, Dominique, Tistaert, Christophe, Van Den Bergh, An, Van Peer, Achiel, Beato, Stefania, Nguyen-Trung, Anh-Thu, Bennett, Joanne, McAllister, Mark, Wong, Mei, Zane, Patricia, Ollier, Céline, Vicat, Pascale, Kolhmann, Markus, Marker, Alexander, Brun, Priscilla, Mazuir, Florent, Beilles, Stéphane, Venczel, Marta, Boulenc, Xavier, Loos, Petra, Lennernäs, Hans, Abrahamsson, Bertil

“…Predicting oral bioavailability (Foral) is of importance for estimating systemic exposure of orally administered drugs. Physiologically-based pharmacokinetic…”
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