Transporters play a critical role in drug absorption, distribution, and elimination, and their involvement in drug-drug interactions (DDIs) can lead to altered drug concentrations and unexpected adverse effects that hamper the effectiveness of the treatment.
Extrapolation of Midazolam Disposition in Neonates Using Physiological-Based Pharmacokinetic/Pharmacodynamic Modeling
There is a shortage of data in clinical studies of neonatal populations, which often utilize extrapolation strategies and model simulation techniques to support drug development and clinical applications.
Utilizing Physiologically Based Pharmacokinetic Models to Support Rational Medication in Chinese Elderly Population
China is undergoing a pronounced shift towards an aging society, wherein the elderly constitute a prominent demographic relying significantly on medications.
Focus Your Obesity Pipeline for Clinical Success: Delivering the Right Compound at the Right Dose for the Right Patient
Driving the development of your obesity drug assets efficiently is critical for success
Simulations Plus Supports New FDA Roadmap for Reducing Animal Testing in Preclinical Safety Studies
Modeling and simulation will be a key component for shift to non-animal methodologies
Introducing NAMVantage(TM), a flagship package offering PBPK and QSP professional services and regulatory strategy combined with built-in coaching and training
Design and Development of Sulfenylated 5-Aminopyrazoles as Inhibitors of Acetylcholinesterase and Butyrylcholinesterase: Exploring the Implication for Aβ1–42 Aggregation Inhibition in Alzheimer’s Disease
Current therapeutic regimens approved to treat Alzheimer's disease (AD) provide symptomatic relief by replenishing the acetylcholine levels in the brain by inhibiting AChE.
Formulation Strategy of BCS-II Drugs by Coupling Mechanistic In-Vitro and Nonclinical In-Vivo Data with PBPK: Fundamentals of Absorption-Dissolution to Parameterization of Modelling and Simulation
BCS class II candidates pose challenges in drug development due to their low solubility and permeability.
Rat-to-Human PBPK Model of U-47700: Unveiling Pharmacokinetic Risks of a Synthetic Opioid Through Interspecies Extrapolation
U-47700, a synthetic μ-opioid receptor agonist and emerging new psychoactive substance, poses critical public health risks due to its high abuse liability and fatal overdose potential.
From In Vivo Predictive Dissolution to Virtual Bioequivalence: A GastroPlus®-Driven Framework for Generic Candesartan Cilexetil Tablets
Candesartan cilexetil, a Biopharmaceutics Classification System (BCS) II prodrug, demonstrates compromised bioavailability attributable to its limited aqueous solubility coupled with P-glycoprotein (P-gp)-mediated efflux and hepatic first-pass metabolism, thereby introducing complexities in generic drug bioequivalence assessments.
Mode of Action Approach Supports a Lack of Carcinogenic Potential of Six Organic UV Filters
Ultraviolet (UV) filters, the active ingredients in sunscreens, have been used for several decades to reduce the risk of acute and chronic damage to the skin from solar UV radiation, which can lead to skin cancer.
Mode of Action Approach Supports a Lack of Carcinogenic Potential of Six Organic UV Filters
Ultraviolet (UV) filters, the active ingredients in sunscreens, have been used for several decades to reduce the risk of acute and chronic damage to the skin from solar UV radiation, which can lead to skin cancer.
Anxiety Disorders, PTSD and OCD: Systematic Review of Approved Psychiatric Medications (2008–2024) and Pipeline Phase III Medications
This systematic review examines psychiatric medications approved by the FDA for anxiety disorders, post-traumatic stress disorder (PTSD) and obsessive-compulsive disorder (OCD) from 2008 to 2024 and describes the mechanism of action, indications for both labelled and off-label uses, evidence for efficacy, dosing and adverse effects for each medication.
Simulations Plus Reports Second Quarter Fiscal 2025 Financial Results
Total revenue grew 23% year-over-year driven by strong growth in both software and services
Advances in Physiologically Based Pharmacokinetic (PBPK) Modeling and its Regulatory Utility to Support Oral Drug Product Development and Harmonization
This report summarizes the proceedings of Session 1 of the one-day public workshop titled “Advances in PBPK Modeling and its Regulatory Utility for Oral Drug Product Development” hosted by the U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) on October 12, 2023.
High vs. Low Vancomycin Therapeutic Concentrations in Periprosthetic Joint Infection: A Retrospective Cohort Analysis
Current guidelines recommend vancomycin concentrations of 10–20 μg/mL for most infections, with higher levels (15–20 μg/mL) suggested for severe cases.
Accelerating Small Molecule GLP-1 Agonist Optimization: AI-Driven Design Meets Mechanistic Modeling for a First-to-Invent Advantage
In a fast-paced industry with big budget competition, you need every tool and approach to succeed.
PBPK Modeling to Support Bioavailability and Bioequivalence Assessment in Pediatric Populations
This report summarizes the proceedings for Session 3 of the one-day public workshop entitled “Advances in PBPK Modeling and its Regulatory Utility for Oral Drug Product Development” a jointly sponsored workshop by U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) on October 12, 2023.
In Vitro and In Vivo Pharmacokinetic Characterization of 7-Hydroxymitragynine, an Active Metabolite of Mitragynine, in Sprague-Dawley Rats
Kratom, a Southeast Asian tree, has been researched for its potential as a therapeutic for substance use disorders.
Antiviral Activity of Halogenated Compounds Derived from L-Tyrosine Against SARS-CoV-2
Currently, there are no effective medications for treating all the clinical conditions of patients with COVID-19.