The number of opioid overdose deaths in the United States has continued to increase for more than two decades.
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 Every FDA-Approved Drug 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
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.
Establishment of Biopredictive Dissolution and Bioequivalence Safe Space Using the Physiologically Based Biopharmaceutics Modeling for Tacrolimus Extended-Release Capsules
A slight variation in in vivo exposure for tacrolimus extended-release (ER) capsules, which have a narrow therapeutic index (NTI), significantly affects the pharmacodynamics of the drug. Generic drug bioequivalence (BE) standards are stricter, necessitating accurate assessment of the rate and extent of drug release.
Advancements in Ocular Modelling and Simulations: Key Considerations and Case Studies
This review paper discusses the key aspects of ocular biopharmaceutics, with emphasis on the crucial role played by ocular compartmental modelling and simulation in deciphering physiological conditions related to various eye diseases.
Current State and New Horizons in Applications of Physiologically Based Biopharmaceutics Modeling (PBBM): A Workshop Report
This report summarizes the proceedings for Day 3 of the workshop titled “Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives”.
Less Coding, More Exploring: Demystifying Built-in Libraries in MonolixSuite
Does this sound familiar? You are a pharmacometric modeler facing a tight deadline.
Predicting Pharmacokinetics of Active Constituents in Spatholobi caulis by Using Physiologically Based Pharmacokinetic Models
Spatholobi Caulis (SPC) is a medicinal plant that mainly grows in China and Southeast Asian countries and commonly used in clinics; the pharmacokinetic characteristics in humans need to be determined.
De-Risking Clinical Hepatotoxicity in Early Drug Discovery
Hepatotoxicity due to drugs and other xenobiotics, also known as drug-induced liver injury (DILI), is a primary reason for 1) the termination of drug development programs, 2) the delay of approving otherwise efficacious drugs by requiring large and expensive safety-focused clinical trials, 3) the restriction on the clinical use of approved drugs by the inclusion of black box warnings, and 4) the removal of approved drugs from the market.
Physiologically Based Biopharmaceutics Modeling Coupled with Biopredictive Dissolution in Development of Bioequivalent Formulation for Mesalamine Enteric Coated Tablet: A Tough Nut to Crack
Mesalamine is a locally acting anti-inflammatory drug used to treat mild to moderate ulcerative colitis.
Hydrogel for Sustained Delivery of Therapeutic Agents
In recent years, hydrogels have emerged as a highly promising platform for the sustained delivery of therapeutic agents, addressing critical challenges in drug delivery systems, from controlled release to biocompatibility.
Advancing understanding of human variability through toxicokinetic modeling, in vitro-in vivo extrapolation, and new approach methodologies
The merging of physiology and toxicokinetics, or pharmacokinetics, with computational modeling to characterize dosimetry has led to major advances for both the chemical and pharmaceutical research arenas.
A review of quantitative structure-activity relationship: The development and current status of data sets, molecular descriptors and mathematical models
Developing Quantitative Structure-Activity Relationship (QSAR) models applicable to general molecules is of great significance for molecular design in many disciplines.