An IQ Consortium Perspective on Connecting Dissolution Methods to In Vivo Performance: Analysis of an Industrial Database and Case Studies to Propose a Workflow

Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms Using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies

(2021) Tycho Heimbach et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Current status and future opportunities for incorporation of dissolution data in pbpk modeling for pharmaceutical development and regulatory applications: orbito consortium commentary

(2020) Masoud Jamei et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Best Practices in the Development and Validation of Physiologically Based Biopharmaceutics Modeling. A Workshop Summary Report.

(2020) Neil Parrott et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Introduction to the OrBiTo decision tree to select the most appropriate in vitro methodology for release testing of solid oral dosage forms during development

(2018) C.J. Andreas 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

Relative Bioavailability Risk Assessment: A Systematic Approach to Assessing In Vivo Risk Associated With CM&C-Related Changes

(2018) Aktham Aburub et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

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

(2018) James Butler et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

IMI – oral biopharmaceutics tools project – evaluation of bottom-up PBPK prediction success part 1: Characterisation of the OrBiTo database of compounds

(2017) Alison Margolskee et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

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

(2017) Alison Margolskee et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

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

(2017) Adam S. Darwich et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

The Role of Physiologically Based Oral Absorption Modelling in Formulation Development Under a Quality by Design Paradigm

(2017) Filippos Kesisoglou   JOURNAL OF PHARMACEUTICAL SCIENCES

Validation of Dissolution Testing with Biorelevant Media: An OrBiTo Study

(2017) James Mann et al.   MOLECULAR PHARMACEUTICS

Increased bioavailability of celecoxib under fed versus fasted conditions is determined by postprandial bile secretion as demonstrated in a dynamic gastrointestinal model

(2016) Eric Lyng et al.   DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY

Assessing Supersaturation and Its Impact on In Vivo Bioavailability of a Low-Solubility Compound ABT-072 With a Dual pH, Two-Phase Dissolution Method

(2016) Yi Shi et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Physiologically Based Absorption Modeling for Amorphous Solid Dispersion Formulations

(2016) Amitava Mitra et al.   MOLECULAR PHARMACEUTICS

Characteristics of the Human Upper Gastrointestinal Contents in the Fasted State Under Hypo- and A-chlorhydric Gastric Conditions Under Conditions of Typical Drug – Drug Interaction Studies

(2016) Chara Litou et al.   PHARMACEUTICAL RESEARCH

In-vitro simulation of luminal conditions for evaluation of performance of oral drug products: Choosing the appropriate test media

(2015) Constantinos Markopoulos et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Effect of Surfactants, Gastric Emptying, and Dosage Form on Supersaturation of Dipyridamole in an in Vitro Model Simulating the Stomach and Duodenum

(2014) A. Mitra et al.   MOLECULAR PHARMACEUTICS

Mathematical modeling of drug dissolution

(2013) J. Siepmann et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Impaired Drug Absorption Due to High Stomach pH: A Review of Strategies for Mitigation of Such Effect To Enable Pharmaceutical Product Development

(2013) Amitava Mitra et al.   MOLECULAR PHARMACEUTICS

Drug Absorption Interactions Between Oral Targeted Anticancer Agents and PPIs: Is pH-Dependent Solubility the Achilles Heel of Targeted Therapy?

(2012) N R Budha et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Prediction of Human Oral Plasma Concentration-Time Profiles Using Preclinical Data

(2011) An Van den Bergh et al.   CLINICAL PHARMACOKINETICS

Simulation of Human Intravenous and Oral Pharmacokinetics of 21 Diverse Compounds Using Physiologically Based Pharmacokinetic Modelling

(2011) Hannah M. Jones et al.   CLINICAL PHARMACOKINETICS

PhRMA CPCDC Initiative on Predictive Models of Human Pharmacokinetics, Part 1: Goals, Properties of the Phrma Dataset, and Comparison with Literature Datasets

(2011) Patrick Poulin et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Using Absorption Simulation and Gastric pH Modulated Dog Model for Formulation Development To Overcome Achlorhydria Effect

(2011) Amitava Mitra et al.   MOLECULAR PHARMACEUTICS

Predicting Intestinal Precipitation—A Case Example for a Basic BCS Class II Drug

(2010) Sara Carlert et al.   PHARMACEUTICAL RESEARCH

A comparative study of different release apparatus in generating in vitro–in vivo correlations for extended release formulations

(2009) N. Fotaki et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS