Understanding Mechanisms of Food Effect and Developing Reliable PBPK Models Using a Middle-out Approach

The mechanisms of pharmacokinetic food-drug interactions – A perspective from the UNGAP group

(2019) Mirko Koziolek et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Bridging in vitro dissolution and in vivo exposure for acalabrutinib. Part II. A mechanistic PBPK model for IR formulation comparison, proton pump inhibitor drug interactions, and administration with acidic juices

(2019) Xavier J.H. Pepin et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Phase-Appropriate Application of Analytical Methods to Monitor Subvisible Particles Across the Biotherapeutic Drug Product Life Cycle

(2019) Roman Mathaes et al.   AAPS Journal

Mechanistic Physiologically Based Pharmacokinetic Modeling of the Dissolution and Food Effect of a Biopharmaceutics Classification System IV Compound—The Venetoclax Story

(2018) Arian Emami Riedmaier et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Food Effect Projections via Physiologically Based Pharmacokinetic Modeling: Predictive Case Studies

(2018) Christophe Tistaert et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Food for thought: formulating away the food effect - a PEARRL review

(2018) Joseph P. O'Shea et al.   JOURNAL OF PHARMACY AND PHARMACOLOGY

The impact of food intake on the luminal environment and performance of oral drug products with a view to in vitro and in silico simulations: a PEARRL review

(2018) Christina Pentafragka et al.   JOURNAL OF PHARMACY AND PHARMACOLOGY

Prediction of pKa Values for Neutral and Basic Drugs based on Hybrid Artificial Intelligence Methods

(2018) Mengshan Li et al.   Scientific Reports

Mechanistic investigation of the negative food effect of modified release zolpidem

(2017) Cord J. Andreas et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Evaluation of Dissolution in the Lower Intestine and Its Impact on the Absorption Process of High Dose Low Solubility Drugs

(2017) Danai Georgaka et al.   MOLECULAR PHARMACEUTICS

Justification of Drug Product Dissolution Rate and Drug Substance Particle Size Specifications Based on Absorption PBPK Modeling for Lesinurad Immediate Release Tablets

(2016) Xavier J. H. Pepin et al.   MOLECULAR PHARMACEUTICS

Inter-subject variability in intestinal drug solubility

(2015) Sarit Cohen Rabbie et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Size selectivity of intestinal mucus to diffusing particulates is dependent on surface chemistry and exposure to lipids

(2015) Hasan M. Yildiz et al.   JOURNAL OF DRUG TARGETING

Direct Measurement of Macromolecule-Coated Colloid–Mucus Interactions

(2015) Julia C. Swavola et al.   LANGMUIR

Mucus as a Barrier to Drug Delivery - Understanding and Mimicking the Barrier Properties

(2014) Marie Boegh et al.   BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY

Viscosity-mediated negative food effect on oral absorption of poorly-permeable drugs with an absorption window in the proximal intestine: In vitro experimental simulation and computational verification

(2014) Sandra Cvijić et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Quantification of Gastrointestinal Liquid Volumes and Distribution Following a 240 mL Dose of Water in the Fasted State

(2014) Deanna M. Mudie et al.   MOLECULAR PHARMACEUTICS

Combining the ‘bottom up’ and ‘top down’ approaches in pharmacokinetic modelling: fitting PBPK models to observed clinical data

(2013) Nikolaos Tsamandouras et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Mucus as a barrier to lipophilic drugs

(2013) Hakon H. Sigurdsson et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Biorelevant solubility of poorly soluble drugs: Rivaroxaban, furosemide, papaverine and niflumic acid

(2013) Krisztina Takács-Novák et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Human in Vivo Regional Intestinal Permeability: Importance for Pharmaceutical Drug Development

(2013) Hans Lennernäs   MOLECULAR PHARMACEUTICS

Mechanistic investigation of food effect on disintegration and dissolution of BCS class III compound solid formulations: the importance of viscosity

(2012) Asma Radwan et al.   BIOPHARMACEUTICS & DRUG DISPOSITION

Phosphatidylcholine as a constituent in the colonic mucosal barrier—Physiological and clinical relevance

(2010) Robert Ehehalt et al.   BIOCHIMICA ET BIOPHYSICA ACTA-MOLECULAR AND CELL BIOLOGY OF LIPIDS

Multiple Peaking Phenomena in Pharmacokinetic Disposition

(2010) Neal M. Davies et al.   CLINICAL PHARMACOKINETICS

Forecasting in vivo oral absorption and food effect of micronized and nanosized aprepitant formulations in humans

(2010) Yasushi Shono et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Mucus-penetrating nanoparticles for drug and gene delivery to mucosal tissues

(2008) Samuel K. Lai et al.   ADVANCED DRUG DELIVERY REVIEWS