Translational Modeling Strategies for Orally Administered Drug Products: Academic, Industrial and Regulatory Perspectives

A Mechanistic Physiologically-Based Biopharmaceutics Modeling (PBBM) Approach to Assess the In Vivo Performance of an Orally Administered Drug Product: From IVIVC to IVIVP

(2020) Marival Bermejo et al.   Pharmaceutics

Physiologically Based Pharmacokinetic Modeling to Supplement Nilotinib Pharmacokinetics and Confirm Dose Selection in Pediatric Patients

(2019) Tycho Heimbach et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Dissolution and Translational Modeling Strategies Toward Establishing an In Vitro-In Vivo Link—a Workshop Summary Report

(2019) Tycho Heimbach et al.   AAPS Journal

Measuring the Impact of Gastrointestinal Variables on the Systemic Outcome of Two Suspensions of Posaconazole by a PBPK Model

(2018) Bart Hens et al.   AAPS Journal

Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective

(2018) Mohamad Shebley et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

PBPK in Preterm and Term Neonates: A Review

(2018) Robin Michelet et al.   CURRENT PHARMACEUTICAL DESIGN

Linking the concentrations of itraconazole and 2-hydroxypropyl-β-cyclodextrin in human intestinal fluids after oral intake of Sporanox ®

(2018) Philippe Berben et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

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

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

Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report

(2018) Sandra Suarez-Sharp et al.   AAPS Journal

Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the U.S. Food and Drug Administration’s Office of Clinical Pharmacology

(2018) Manuela Grimstein et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Application of a Dynamic Fluid and pH Model to Simulate Intraluminal and Systemic Concentrations of a Weak Base in GastroPlus™

(2018) Bart Hens et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Assessment of Bioequivalence of Weak Base Formulations Under Various Dosing Conditions Using Physiologically Based Pharmacokinetic Simulations in Virtual Populations. Case Examples: Ketoconazole and Posaconazole

(2017) Rodrigo Cristofoletti et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Low Buffer Capacity and Alternating Motility along the Human Gastrointestinal Tract: Implications for in Vivo Dissolution and Absorption of Ionizable Drugs

(2017) Bart Hens et al.   MOLECULAR PHARMACEUTICS

Variability in Mass Spectrometry-based Quantification of Clinically Relevant Drug Transporters and Drug Metabolizing Enzymes

(2017) Christine Wegler et al.   MOLECULAR PHARMACEUTICS

In Silico Modeling Approach for the Evaluation of Gastrointestinal Dissolution, Supersaturation, and Precipitation of Posaconazole

(2017) Bart Hens et al.   MOLECULAR PHARMACEUTICS

Use of physiologically relevant biopharmaceutics tools within the pharmaceutical industry and in regulatory sciences: Where are we now and what are the gaps?

(2016) Talia Flanagan et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Gastrointestinal and Systemic Monitoring of Posaconazole in Humans After Fasted and Fed State Administration of a Solid Dispersion

(2016) Bart Hens et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Supersaturation and Precipitation of Posaconazole Upon Entry in the Upper Small Intestine in Humans

(2016) Bart Hens et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Predicting the Effect of CYP3A Inducers on the Pharmacokinetics of Substrate Drugs Using Physiologically Based Pharmacokinetic (PBPK) Modeling: An Analysis of PBPK Submissions to the US FDA

(2015) Christian Wagner et al.   CLINICAL PHARMACOKINETICS

Advances and challenges in PBPK modeling – Analysis of factors contributing to the oral absorption of atazanavir, a poorly soluble weak base

(2015) Mark Berlin et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Trends in the Precipitation and Crystallization Behavior of Supersaturated Aqueous Solutions of Poorly Water-Soluble Drugs Assessed Using Synchrotron Radiation

(2015) Shweta A. Raina et al.   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

PBPK models for the prediction of in vivo performance of oral dosage forms

(2013) Edmund S. Kostewicz et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

PBTK modelling platforms and parameter estimation tools to enable animal-free risk assessment

(2013) Jos G. Bessems et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Characterizing the disposition, metabolism, and excretion of an orally active pan-deacetylase inhibitor, panobinostat, via trace radiolabeled 14C material in advanced cancer patients

(2012) Sally Clive et al.   CANCER CHEMOTHERAPY AND PHARMACOLOGY

Anatomical, Physiological and Metabolic Changes with Gestational Age during Normal Pregnancy

(2012) Khaled Abduljalil et al.   CLINICAL PHARMACOKINETICS

Physiologically Based Pharmacokinetics Joined With In Vitro–In Vivo Extrapolation of ADME: A Marriage Under the Arch of Systems Pharmacology

(2012) A Rostami-Hodjegan   CLINICAL PHARMACOLOGY & THERAPEUTICS

Evaluation of gastrointestinal drug supersaturation and precipitation: Strategies and issues

(2012) Jan Bevernage et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

The migrating motor complex: control mechanisms and its role in health and disease

(2012) Eveline Deloose et al.   Nature Reviews Gastroenterology & Hepatology

pH-Induced Precipitation Behavior of Weakly Basic Compounds: Determination of Extent and Duration of Supersaturation Using Potentiometric Titration and Correlation to Solid State Properties

(2012) Yi-Ling Hsieh et al.   PHARMACEUTICAL RESEARCH

Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review

(2010) P Zhao et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Pharmaceutical applications of cyclodextrins: basic science and product development

(2010) Thorsteinn Loftsson et al.   JOURNAL OF PHARMACY AND PHARMACOLOGY

Effect of PCBs on the lactational transfer of methyl mercury in mice: PBPK modeling

(2008) Sun Ku Lee et al.   ENVIRONMENTAL TOXICOLOGY AND PHARMACOLOGY