Transporters Module enables data-driven decision-making by leveraging AI/machine learning (ML) models trained on premium experimental datasets.
Understanding the FDA’s Draft Guidance on Artificial Intelligence to Support Regulatory Decision-Making
The pharmaceutical industry is on the brink of a transformative shift, with artificial intelligence (AI) increasingly being leveraged across the drug product lifecycle.
Modeling and Simulation of Acetaminophen Pharmacokinetics and Hepatic Biomarkers After Overdoses of Extended-Release and Immediate-Release Formulations in Healthy Adults Using the Quantitative Systems Toxicology Software Platform DILIsym
Acetaminophen (APAP) has been formulated as immediate-, modified-, and extended-release tablets (APAP-IR, -MR, and -ER, respectively).
In vivo Performance of Amorphous Solid Dispersions Based on Water-Insoluble Versus Water-Soluble Carriers: Fenofibrate Case Study
The objective of this study is to address the unanswered question whether sustained supersaturation generated from amorphous solid dispersions (ASDs) formulated in insoluble hydrogel carriers will result in better bioavailability over that of spring-and-parachute type of dissolution profiles of ASDs formulated in water-soluble carriers
Application of an Interdisciplinary Approach to Form Selection in Drug Development
Selecting the development form of an active pharmaceutical ingredient (API) in drug development is key to determining the final performance of the drug substance and drug product.
Simulations Plus and Enabling Technologies Consortium Announce Strategic Collaboration to Advance GastroPlus® Enhancements
Industry partners to provide funding and data to support ACAT™ model improvements
Physiologically Based Pharmacokinetic and Physiologically Based Biopharmaceutic Models Research in Latin America: A Regional Level Bibliometric Analysis, 2011-2023
The landscape of scientific research in Latin America (LA), particularly in the realms of the Physiologically Based Pharmacokinetic (PBPK) and Physiologically Based Biopharmaceutic models (PBPM), is a mosaic of varied contributions, collaborations, and specializations.
Dosage Optimization Using Physiologically Based Pharmacokinetic Modeling for Pediatric Patients with Renal Impairment: A Case Study of Meropenem
The pharmacokinetics of renally eliminated antibiotics can be influenced by changes associated with renal function and development in a growing subject. Little is known about the effects of renal insufficiency on the pharmacokinetics of meropenem in pediatric subjects.
Evaluating the effectiveness of intranasal reversal agents using FDA’s translational model of opioid overdose
The number of opioid overdose deaths in the United States has continued to increase for more than two decades.
Association Between Abatacept Exposure Levels and Infection Occurrence in Patients with Rheumatoid Arthritis: Post Hoc Analysis of the AVERT-2 Study
To determine if higher serum exposure during subcutaneous (SC) abatacept treatment was associated with an increased infection risk in adult patients with early rheumatoid arthritis (RA).
Representing a Drug in a Complement QSP Model: Eculizumab as a Case Study
This blog post continues our ongoing series on leveraging quantitative systems pharmacology (QSP) to enhance drug development.
Simulations Plus Supported Development of Majority of FDA-Approved Drugs in 2024
SLP’s technology and expertise accelerates drug development and supports critical advancements in global healthcare
Choosing Your PK/PD Modeling Software: Key Questions About Monolix, Answered
When it comes to PK/PD modeling, many researchers stick with the tools they know, even when those tools may not be the most efficient or insightful.
Simulations Plus Reports First Quarter Fiscal 2025 Financial Results
Total revenue up 31% year-over-year primarily driven by strong software growth
Formulation Development and Evaluation, in silico PBPK Modeling and in vivo Pharmacodynamic Studies of Clozapine Matrix Type Transdermal Patches
Clozapine is a potent serotonin receptor antagonist and commonly used for the treatment of Schizophrenia.
Improving Individualized Salbutamol Treatment: A Population Pharmacokinetic Model for Oral Salbutamol in Virtual Patients
Salbutamol, a short-acting β2-agonist used in asthma treatment, is available in multiple formulations, including inhalers, nebulizers, oral tablets, and intravenous, intramuscular, and subcutaneous routes.
Characterization of Preclinical Radio ADME Properties of ARV-471 for Predicting Human PK Using PBPK Modeling
Proteolysis-targeting chimeras (PROTACs) represent a promising class of drugs that can target disease-causing proteins more effectively than traditional small molecule inhibitors can, potentially revolutionizing drug discovery and treatment strategies.
10 Most Read Journal Articles of 2024
In an industry that’s constantly evolving, staying ahead of the curve is crucial. Every breakthrough, every new piece of research can shape the future—and if you’re not in the loop, you risk falling behind.
Advancing Systemic Toxicity Risk Assessment: Evaluation of a NAM-based Toolbox Approach
For many years, a method that allowed systemic toxicity safety assessments to be conducted without generating new animal test data, seemed out of reach.