Physiologically Based Biopharmaceutics Modeling to Demonstrate Virtual Bioequivalence and Bioequivalence Safe-space for Ribociclib which has Permeation Rate-controlled Absorption

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

Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls: A Workshop Summary Report

(2020) Xavier J.H. Pepin et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Evaluation of Absolute Oral Bioavailability and Bioequivalence of Ribociclib, a Cyclin‐Dependent Kinase 4/6 Inhibitor, in Healthy Subjects

(2020) Yan Ji et al.   Clinical Pharmacology in Drug Development

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

(2019) Tycho Heimbach et al.   AAPS Journal

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

Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. case example: Naproxen

(2019) Ioannis Loisios-Konstantinidis et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

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

The potent and selective cyclin-dependent kinases 4 and 6 inhibitor ribociclib (LEE011) is a versatile combination partner in preclinical cancer models

(2018) Sunkyu Kim et al.   Oncotarget

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

Evaluation of Drug-Drug Interaction Potential Between Sacubitril/Valsartan (LCZ696) and Statins Using a Physiologically Based Pharmacokinetic Model

(2017) Wen Lin et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Integrated TK–TD modeling for drug-induced concurrent tachycardia and QT changes in beagle dogs

(2017) Fan Wu et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Validation of Dissolution Testing with Biorelevant Media: An OrBiTo Study

(2017) James Mann et al.   MOLECULAR PHARMACEUTICS

A Phase I Study of the Cyclin-Dependent Kinase 4/6 Inhibitor Ribociclib (LEE011) in Patients with Advanced Solid Tumors and Lymphomas

(2016) J. R. Infante et al.   CLINICAL CANCER RESEARCH

Physiologically Based Absorption Modeling to Impact Biopharmaceutics and Formulation Strategies in Drug Development—Industry Case Studies

(2016) Filippos Kesisoglou et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

A Physiologically Based Pharmacokinetic Model to Describe Artemether Pharmacokinetics in Adult and Pediatric Patients

(2016) Wen Lin et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

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

Rate- and Extent-Limiting Factors of Oral Drug Absorption: Theory and Applications

(2015) Kiyohiko Sugano et al.   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

Dissolution Media Simulating Conditions in the Proximal Human Gastrointestinal Tract: An Update

(2008) Ekarat Jantratid et al.   PHARMACEUTICAL RESEARCH