Record-setting attendance for the global pharmacometrics community

Using PBPK modeling to assess the impact of diseases on oral drug absorption: case study in HIV-infected patients
Randomized clinical trial is the most effective way to determine whether a cause-and-effect relationship exists between an intervention and a predefined clinical outcome.

Simulation of febuxostat pharmacokinetics in healthy subjects and patients with impaired kidney function using physiologically based pharmacokinetic modeling
Febuxostat is recommended by the American College of Rheumatology Gout Management Guidelines as a first-line therapy for lowering the level of urate in patients with gout.

Data required to build a fit-for-purpose PBPK model: How much is necessary?
PBPK/PBBM model development can be initiated at any stage of product development

Simulations Plus Collaborates with Multinational Pharmaceutical Company to Provide Modeling & Simulation Support for COVID-19 Treatment
Simulations Plus' Cognigen division worked with a major pharmaceutical company to implement modeling and simulation activities to support the development of a candidate COVID-19 therapy.

Simulations Plus Sets Date for Third Quarter Fiscal Year 2022 Earnings Release and Conference Call
Conference call to be on Wednesday, July 6, 2022, at 5:00 PM ET

Impact of Composition and Morphology of Ketoconazole-Loaded Solid Lipid Nanoparticles on Intestinal Permeation and Gastroplus-Based Prediction Studies
Ketoconazole (KTZ) is a potential oral antifungal agent to control systemic and local infections.

From traditional to data-driven medicinal chemistry: A case study
Artificial intelligence (AI) and data science are beginning to impact drug discovery.

Machine Learning guided early drug discovery of small molecules
Machine learning (ML) approaches have been widely adopted within the early stages of the drug discovery process, particularly within the context of small-molecule drug...

An update on the comparison of lixivaptan’s liver safety profile
An update from Dr. Paul B. Watkins on the comparison of lixivaptan’s liver safety profile

DILIsym Software Publication Outlines Impact on the CGRP Field for Migraine
DILIsym application contributes to approval of new drugs for migraine treatment

Predictive Dissolution Modeling with Clinically Relevant Specifications
The role of biopharmaceutics risk assessment

June 2022 GastroPlus Newsletter
Hello again GastroPlus scientists, Simulations Plus is a great place to work.

Absence of association between abatacept exposure levels and initial infection in patients with RA: a post hoc analysis of the randomized, placebo-controlled AVERT-2 study
Infections are the most commonly reported AEs in patients with RA treated with immunosuppressive therapies, and

Using GastroPlus to teach complex biopharmaceutical concepts
This report showcases the use of the software GastroPlus in an undergraduate-level pharmacy course.

Simulations Plus General Overview
Our solutions inform the entire drug development process

Simulations Plus Releases ADMET Predictor Version 10.4 (X.4)
New 3D structure generation functionality and extensions to the HTPK Simulation Module among the many enhancements

Chronotherapy based on modified-release hydrocortisone to restore the physiological cortisol diurnal rhythm
In this inspirational note, we describe the development of an endocrine chronotherapy to restore the physiological rhythm of the essential adrenal stress hormone, cortisol.

The Use of Physiologically Based Pharmacokinetic Analyses-in Biopharmaceutics Applications -Regulatory and Industry Perspectives
The use of physiologically based pharmacokinetic (PBPK) modeling to support the drug product quality attributes, also known as physiologically based biopharmaceutics modeling...