Physiologically based pharmacokinetic modeling in regulatory decision‐making at the European Medicines Agency

Elisa Luzon, Kevin Blake, Susan Cole, +3

Clinical Pharmacology & Therapeutics

European Medicines AgencyPhysiologically Based PharmacokineticsPharmacokinetic ModelingPharmacodynamicsRegulatory Procedures +12

EXPRESSION OF CYP3A ISOFORMS AND P‐GLYCOPROTEIN IN HUMAN STOMACH, JEJUNUM AND ILEUM

Roberto Canaparo, Niklas Finnström, Loredana Serpe, +5

Clinical and Experimental Pharmacology and Physiology

Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report

Sandra Suarez‐Sharp, Michael R. Cohen, Filippos Kesisoglou, +15

The AAPS Journal

Drug TestAnalytical ChemistryWorkshop Summary ReportClinical ChemistryMedicine

Effects of caffeine intake on the pharmacokinetics of melatonin, a probe drug for CYP1A2 activity

Sebastian Härtter, Anna Nordmark, Dirk‐Matthias Rose, +3

British Journal of Clinical Pharmacology

Physiologically Based Models in Regulatory Submissions: Output From the ABPI/MHRA Forum on Physiologically Based Modeling and Simulation

Terry Shepard, Graham Scott, Susan Cole, +2

CPT Pharmacometrics & Systems Pharmacology

EngineeringPhysiological StatusPhysiological RegulationPhysiologically-based Pharmacokinetic ModelingPharmacodynamic Modeling +19

The effect of the <i>CYP1A2 *1F</i> mutation on CYP1A2 inducibility in pregnant women

Anna Nordmark, Stefan Lundgren, Birgitta Ask, +2

British Journal of Clinical Pharmacology

<i>In Vivo</i> Predictive Dissolution (IPD) and Biopharmaceutical Modeling and Simulation: Future Use of Modern Approaches and Methodologies in a Regulatory Context

Hans Lennernäs, Anders Lindahl, A. Van Peer, +12

Molecular Pharmaceutics

Biopharmaceutical ModelingGastroenterologyBiomedical EngineeringAnnual Orbito MeetingPhysiologically-based Pharmacokinetic Modeling +17

Dietary caffeine as a probe agent for assessment of cytochrome P4501A2 activity in random urine samples

Anna Nordmark, Stefan Lundgren, Sven Cnattingius, +1

British Journal of Clinical Pharmacology

A formulation comparison between micro- and nanosuspensions: the importance of particle size for absorption of a model compound, following repeated oral administration to rats during early development

Kalle Sigfridsson, Anna Nordmark, Stefanie Theilig, +1

Drug Development and Industrial Pharmacy

Discovery and characterization of AZD9272 and AZD6538—Two novel mGluR5 negative allosteric modulators selected for clinical development

Patrick Raboisson, Anna Breitholtz‐Emanuelsson, Henrik Dahllöf, +15

Bioorganic & Medicinal Chemistry Letters

Negative Allosteric ModulatorsMolecular PharmacologyG Protein-coupled ReceptorMedicineDrug Discovery +4