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

Biopharmaceutics Applications of Physiologically Based Pharmacokinetic Absorption Modeling and Simulation in Regulatory Submissions to the U.S. Food and Drug Administration for New Drugs

(2021) Fang Wu et al.   AAPS Journal

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

(2020) Sandra Suarez-Sharp et al.   PHARMACEUTICAL RESEARCH

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

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

(2019) Tycho Heimbach et al.   AAPS Journal

PBPK Absorption Modeling: Establishing the In Vitro–In Vivo Link—Industry Perspective

(2019) Cordula Stillhart et al.   AAPS Journal

Bridging in vitro dissolution and in vivo exposure for acalabrutinib. Part I. Mechanistic modelling of drug product dissolution to derive a P-PSD for PBPK model input

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

Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory Perspectives

(2019) Mark McAllister et al.   Pharmaceutics

Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report

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

A survey on IVIVC/IVIVR development in the pharmaceutical industry – Past experience and current perspectives

(2017) M.A. Nguyen et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Validation of Dissolution Testing with Biorelevant Media: An OrBiTo Study

(2017) James Mann et al.   MOLECULAR PHARMACEUTICS

Regulatory Experience with In Vivo In Vitro Correlations (IVIVC) in New Drug Applications

(2016) Sandra Suarez-Sharp et al.   AAPS Journal

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

In vitro dissolution methodology, mini-Gastrointestinal Simulator (mGIS), predicts better in vivo dissolution of a weak base drug, dasatinib

(2015) Yasuhiro Tsume et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Application of Absorption Modeling to Predict Bioequivalence Outcome of Two Batches of Etoricoxib Tablets

(2014) Amitava Mitra et al.   AAPS PHARMSCITECH

Pharmacokinetic Drug Interactions with Vandetanib during Coadministration with Rifampicin or Itraconazole

(2013) Paul Martin et al.   Drugs in research & development

Pharmacokinetics of Vandetanib: Three Phase I Studies in Healthy Subjects

(2011) Paul Martin et al.   CLINICAL THERAPEUTICS

PhRMA CPCDC initiative on predictive models of human pharmacokinetics, part 2: Comparative assessment of prediction methods of human volume of distribution

(2011) Rhys Do Jones et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Clinical Relevance of Dissolution Testing in Quality by Design

(2008) Paul A. Dickinson et al.   AAPS Journal