Many compounds that appear promising in preclinical species, fail in human clinical trials due to safety concerns.
Bridging inhaled aerosol dosimetry to physiologically based pharmacokinetic modeling for toxicological assessment: nicotine delivery systems and beyond
One of the challenges for toxicological assessment of inhaled aerosols is to accurately predict their deposited and absorbed dose.
Comparison of the Hepatotoxic Potential of Two Treatments for Autosomal-Dominant Polycystic Kidney DiseaseUsing Quantitative Systems Toxicology Modeling
Autosomal-dominant polycystic kidney disease (ADPKD) is an orphan disease with few current treatment options.
Physiologically Based Pharmacokinetic Model to Support Ophthalmic Suspension Product Development
FDA’s Orange Book lists 17 currently marketed active pharmaceutical ingredients (API) formulated within ophthalmic suspensions in which a majority has 90% or more of the API undissolved.
In Vitro Dissolution and in Silico Modeling Shortcuts in Bioequivalence Testing
To review in vitro testing and simulation platforms that are in current use to predict in vivo performances of generic products as well as other situations to provide evidence for biowaiver and support drug formulations development.
The Significance of Utilizing In Vitro Transfer Model and Media Selection to Study the Dissolution Performance of Weak Ionizable Bases: Investigation Using Saquinavir as a Model Drug
This study investigated the dissolution behavior of BCS class II ionizable weak base Saquinavir and its mesylate salt in the multi-compartment transfer setup employing different composition of dissolution media.
The Evolving Druggability and Developability Space: Chemically Modified New Modalities and Emerging Small Molecules
The druggability and developability space is rapidly evolving in the post-genomic era.
Simulations Plus Sets Date for First Quarter Fiscal Year 2020 Earnings Release and Conference Call
Conference Call to be on Thursday, January 9, 2020, at 4:15 PM ET
Second basic pKa: An overlooked parameter in predicting phospholipidosis-inducing potential of diamines
In this paper, we present the phospholipidosis-inducing potential (PLIP) of forty fragment-sized diamines derived from N-benzyl-4...
An in vitro toolbox to accelerate anti-malarial drug discovery and development
Modelling and simulation are being increasingly utilized to support the discovery and development of new anti-malarial drugs.
Integrated phytochemical analysis based on UHPLC-LTQ–Orbitrap and network pharmacology approaches to explore the potential mechanism of Lycium ruthenicum Murr. for ameliorating Alzheimer’s disease
Based on compelling experimental and clinical evidence, the fruit of Lycium ruthenicum Murr. (LRM), a unique traditional Tibetan medicine...
Allosteric regulation of protein 14-3-3ζ scaffold by small-molecule editing modulates histone H3 post-translational modifications
Histone post-translational modifications (PTMs) are involved in various biological processes such as transcriptional...
Relationship between plasma concentrations and clinical effects of cariprazine in patients with schizophrenia or bipolar mania
Population pharmacokinetic/pharmacodynamic modeling (via NONMEM) was used to describe longitudinal exposure-response...
Developing Clinically Relevant Dissolution Specifications for Oral Drug Products-Industrial and Regulatory Perspectives
A meeting that was organized by the Academy of Pharmaceutical Sciences Biopharmaceutics and Regulatory Sciences focus groups focused on the challenges of...
Biowaiver Applications in Support of a Polymorph During Late-Stage Clinical Development of Verubecestat—Current Challenges and Future Opportunities for Global Regulatory Alignment
Dissolution experiments to support an active pharmaceutical ingredient (API) form change in Verubecestat immediate release tablets were performed following...
2′-Hydroxychalcones as an alternative treatment for trichomoniasis in association with metronidazole
The treatment for trichomoniasis, based on 5′-nitroimidazol agents, has been presenting failures related to allergic reactions, side effects, and the emergence of resistant isolates.
Prediction characteristics of oral absorption simulation software evaluated using structurally diverse low solubility drugs
The purpose of the present study was to characterize current biopharmaceutics modeling and simulation software regarding the prediction of the fraction of a dose absorbed (Fa) in humans.
Prediction Characteristics of Oral Absorption Simulation Software Evaluated Using Structurally Diverse Low-Solubility Drugs
The purpose of the present study was to characterize current biopharmaceutics modeling and simulation software regarding the prediction of the fraction of a dose absorbed (Fa) in humans.
NDA 211-765 (ubrogepant, AGN-241688)
The primary pharmacology studies conducted characterize ubrogepant as an antagonist at the mouse, rat, rabbit, rhesus monkey...
Application of physiologically based kinetic (PBK) modelling in the next generation risk assessment of dermally applied consumer products
Next Generation Risk Assessment (NGRA) is a procedure that integrates new approach methodologies (NAMs) to assure safety of a product without generating data from animal testing.