It is critical to understand the perspectives and key criteria of global regulatory agencies in the consideration of biowaivers, but many companies have knowledge gaps that hinder their success.
Getting Started with GPX™: A Step-by-Step Guide
With a new interface, updated workflows, and advanced features, it may be challenging to know how to get started with GastroPlus(R) X.
MonolixSuite™ v2024 Product Brochure
A fast easy-to-use and powerful suite of applications for pharmacometrics analysis, modeling and simulation.
New ICH M13A Guideline: Extra Bioequivalence Study Needed for pH-Dependent Drugs with Proton Pump Inhibitors
New guidance was recently released by the International Council for Harmonisation (ICH) regarding bioequivalence for immediate release solid oral dosage forms.
AI for Pharmacological Modeling
Pharmacological modeling plays a key role in drug development by guiding decisions on dosing to optimize safety and efficacy and ultimately streamlining the path to successful therapeutic interventions.
CFD-PK model for nasal suspension sprays: Validation with human adult in vivo data for triamcinolone acetonide
The objectives of this study were to expand and implement a Computational Fluid Dynamics (CFD)-Dissolution, Absorption and Clearance (DAC)-Pharmacokinetics (PK) multi-physics modeling framework for simulating the transport of suspension-based nasal corticosteroid sprays.
Application of Virtual Drug Study to New Drug Research and Development: Challenges and Opportunity
In recent years, virtual drug study, as an emerging research strategy, has become increasingly important in guiding and promoting new drug research and development.
PBPK Modeling of Lamotrigine and Efavirenz during Pregnancy: Implications for Personalized Dosing and Drug-Drug Interaction Management
This study aimed to model the pharmacokinetics of lamotrigine (LTG) and efavirenz (EFV) in pregnant women using physiologically based pharmacokinetic (PBPK) and pregnancy-specific PBPK (p-PBPK) models.
Understanding the mechanisms of food effect on omaveloxolone pharmacokinetics through physiologically based biopharmaceutics modeling
Omaveloxolone is a nuclear factor (erythroid-derived 2)-like 2 activator approved in the United States and the European Union for the treatment of patients with Friedreich ataxia aged ≥16 years, with a recommended dosage of 150 mg orally once daily on an empty stomach.
Multicriteria Decision Aiding in the service of Drug Discovery
Drug discovery is inherently a multicriteria optimization problem.
The Application of Artificial Intelligence/Machine Learning in Drug Development and Regulation
Artificial intelligence/machine learning (AI/ML) are increasingly being utilized in drug development.
Optimization of wet granulation process for manufacturing Rivaroxban generic immediate-release tablets using PBPK modeling and simulations
Granulation is the critical process for the pharmaceutical development of poorly water-soluble drug products.
Women in Science: Evelyn Haupt
In the biopharma industry, we often focus on scientific research and research methodologies. However, software design and usability is also vital in translating complex data and technologies into accessible and user-friendly solutions.
A Semi-Mechanistic Physiologically Based Biopharmaceutics Model to Describe Complex and Saturable Absorption of Metformin: Justification of Dissolution Specifications for Extended Release Formulation
Physiologically based pharmacokinetic (PBPK) or physiologically based biopharmaceutics models (PBBM) demonstrated plethora of applications in both new drugs and generic product development.
Novel omeprazole delayed release orally disintegrating tablets for enhanced patient compliance: a case of model informed formulation development
The advanced in silico simulation tools, such as physiologically based biopharmaceutics models (PBBM) or physiologically based pharmacokinetic models (PBPK), play critical role in model informed formulation development.
Predicting dose-dependent fraction absorbed via a mechanistic absorption model and machine learning
Drug dissolution and absorption are crucial in oral drug delivery.
A Physiologically Based Pharmacokinetic Model of Voriconazole in Human CNS —— Integrating Time-Dependent Inhibition of CYP3A4, Genetic Polymorphisms of CYP2C19 and Possible Transporter Mechanisms
Voriconazole is a classical antifungal drug that is often used to treat CNS fungal infections due to its permeability through the BBB.
Evolve PK+ Comparison Flyer
Only one platform can integrate GastroPlus PBPK outcomes during early design and lead optimization.
Design and Evaluation of 3-Phenyloxetane Derivative Agonists of the Glucagon-Like Peptide-1 Receptor
Various small molecule GLP1R agonists have been developed and tested for treating type 2 diabetes (T2DM) and obesity.
3 Clinical Quality Problems That Simulation Training Solves
Want to see fewer protocol deviations and agile change management in your clinical trials while also reducing burdens on research site staff?