Requirements to Establishing Confidence in Physiologically Based Pharmacokinetic (PBPK) Models and Overcoming Some of the Challenges to Meeting Them

Requirements to Establishing Confidence in Physiologically Based Pharmacokinetic (PBPK) Models and Overcoming Some of the Challenges to Meeting Them

Authors: Peters SA, Dolgos H
Publication: Clin Pharmacokinet
Software: GastroPlus®

When scientifically well-founded, the mechanistic basis of physiologically based pharmacokinetic (PBPK) models can help reduce the uncertainty and increase confidence in extrapolations outside the studied scenarios or studied populations.

Overview of Brazilian Requirements for Therapeutic Equivalence of Orally Inhaled and Nasal Drug Products

Overview of Brazilian Requirements for Therapeutic Equivalence of Orally Inhaled and Nasal Drug Products

Publication: AAPS PharmSciTech
Division: PBPK

Brazil has established a framework for provision of generic pharmaceuticals including for orally inhaled and nasal drug products (OINDP) to its populace.

Stability behaviour of antiretroviral drugs and their combinations. 10: LC-HRMS, LC-MSn, LC-NMR and NMR characterization of fosamprenavir degradation products and in silico determination of their ADMET properties

Stability behaviour of antiretroviral drugs and their combinations. 10: LC-HRMS, LC-MSn, LC-NMR and NMR characterization of fosamprenavir degradation products and in silico determination of their ADMET properties

Publication: Eur J Pharm Biopharm
Software: ADMET Predictor®

The present study focused upon the forced degradation behaviour of fosamprenavir (FPV), an antiretroviral drug. A total of six degradation products (DPs) were separated on a non-polar stationary phase by high performance liquid chromatography (HPLC).

Impact of Intracellular Concentrations on Metabolic Drug-Drug Interaction Studies

Impact of Intracellular Concentrations on Metabolic Drug-Drug Interaction Studies

Publication: AAPS J
Software: ADMET Predictor®

Accurate prediction of drug-drug interactions (DDI) is a challenging task in drug discovery and development. It requires determination of enzyme inhibition in vitro which is highly system-dependent for many compounds.

A focus on riociguat in the treatment of pulmonary arterial hypertension

A focus on riociguat in the treatment of pulmonary arterial hypertension

Publication: Basic Clin Pharmacol Toxicol
Software: ADMET Predictor®

Current treatment of pulmonary arterial hypertension (PAH) targets three signalling pathways: the nitric oxide (NO) pathway, the endothelin pathway and...

Population pharmacokinetic (PopPK) and concentration-QTc analysis of quizartinib in patients (pts) with FLT3-ITD–positive relapsed/refractory (R/R) acute myeloid leukemia (AML)

Population pharmacokinetic (PopPK) and concentration-QTc analysis of quizartinib in patients (pts) with FLT3-ITD–positive relapsed/refractory (R/R) acute myeloid leukemia (AML)

Conference: European Hematology Association (EHA)

Fms-related tyrosine kinase 3 (FLT3) is expressed in hematopoietic progenitor cells;
signaling through FLT3 promotes their proliferation and differentiation. FLT3 is mutated
in approximately 30% of patients with AML.

“Development of Fixed Dose Combination Products” Workshop Report: Considerations of Gastrointestinal Physiology and Overall Development Strategy

“Development of Fixed Dose Combination Products” Workshop Report: Considerations of Gastrointestinal Physiology and Overall Development Strategy

Publication: AAPS J
Software: GastroPlus®

The gastrointestinal (GI) tract is one of the most popular and used routes of drug product administration due to the convenience for better patient compliance and reduced costs to the patient compared to other routes.

Investigation of potent inhibitors of cholinesterase based on thiourea and pyrazoline derivatives: Synthesis, inhibition assay and molecular modeling studies

Investigation of potent inhibitors of cholinesterase based on thiourea and pyrazoline derivatives: Synthesis, inhibition assay and molecular modeling studies

Publication: Bioorg Chem
Software: ADMET Predictor®

Owing to the desperate need of new drugs development to treat Alzheimer's ailment the synthesis of 1-aroyl-3-(5-(4-chlorophenyl)-1,2,4-triazole-3-thioneaminylthioureas (2–6)...