High rates of drug failure cases are a challenge for the pharmaceutical industry to improve preclinical testing.
Project Orbis: Global Collaborative Review Program
In 2019, the FDA Oncology Center of Excellence launched Project Orbis, a global collaborative review program to facilitate faster patient access to innovative cancer therapies across multiple countries.
Prediction of midazolam pediatric plasma profiles for multiple routes of administration using physiologically based pharmacokinetic model
Owing to ethical and logistical constraints, clinical investigation of drugs in the pediatric population is challenging.
The impact and mechanism of ampakine CX1739 on protection against respiratory depression in rats
Abuse of analgesic and sedative drugs often leads to severe respiratory depression and sometimes death.
The UofA Faculty of Pharmacy & Pharm.Sci presents Phytocannabinoids DDIs and more!
Cannabis is a plant with a long history of human pharmacological use, both for recreational purposes and as a medicinal remedy.
Construction and Verification of Physiologically Based Pharmacokinetic Models for Four Drugs Majorly Cleared by Glucuronidation: Lorazepam, Oxazepam, Naloxone, and Zidovudine
Physiologically based pharmacokinetic (PBPK) modeling is less well established for substrates of UDP-glucuronosyltransferases (UGT) than for cytochrome...
The Influence of Structural Patterns on Acute Aquatic Toxicity of Organic Compounds
Investigation of the influence of molecular structure of different organic compounds on acute toxicity towards Fathead minnow..
Quantitative Systems Toxicology Analysis of In Vitro Mechanistic Assays Reveals Importance of Bile Acid Accumulation and Mitochondrial Dysfunction in TAK-875-Induced Liver Injury
TAK-875 (fasiglifam), a GPR40 agonist in development for the treatment of type 2 diabetes (T2D), was voluntarily terminated in Phase III trials due to..
First in class (S,E)-11-[2-(arylmethylene)hydrazono]-PBD analogs as selective CB2 modulators targeting neurodegenerative disorders
Newly designed pyrrolo[2,1-c][1,4]benzodiazepines tricyclic skeleton has shown potential clusters of cannabinoid receptors CB1/CB2 selective ligands.
Quantitative Systems Toxicology Modeling Using DILIsym Suggests That Drug-Induced Liver Injury Can Be Enhanced by Co-administered Drugs and Mitigated by Mitochondrial Biogenesis
Drug-induced liver injury (DILI) can be enhanced by polypharmacy if co-administered drugs induce toxicity via mechanisms that have overlapping pathways.
GastroPlus® Tutorial: Phase 2 Video 1: How to create a new PBPK physiology in GastroPlus
This video will focus on how to create a new PBPK physiology in GastroPlus.
GastroPlus® Tutorial: Phase 2 Video 2: How to set up metabolic clearance using in vitro data
In this video we will show you how to set up metabolic clearance using in vitro data.
MonolixSuite: What’s new in 2020?
MonolixSuite’s latest release (2020) introduces a new application for clinical trial simulations, with a user-friendly interface and interactive plots.
Successful Extrapolation of Paracetamol Exposure from Adults to Infants After Oral Administration of a Pediatric Aqueous Suspension Is Highly Dependent on the Study Dosing Conditions
Extending licensed drug use to the pediatric population has become an essential part of the drug development process.
Delivering on the promise of AI-driven drug discovery with ADMET Predictor® 10 (APX). Background and applications examples
Dr. Marvin Waldman will present a brief background behind generative chemistry applications and their relevance to ADMET Predictor® (APX).
Application of PBPK Modeling and Simulation for Regulatory Decision Making and Its Impact on US Prescribing Information: An Update on the 2018-2019 Submissions to the US FDA’s Office of Clinical Pharmacology
Since 2016, results from physiologically based pharmacokinetic (PBPK) analyses have been routinely found in the clinical pharmacology section of regulatory.
Simulations Plus Extends Partnership with Large Pharmaceutical Company to Further Expand High-Throughput PBPK Capabilities in ADMET Predictor®
Improvements Establish HTPK Simulation Module as Key Gateway for Lead Compound Selection
Use of Physiologically Based Pharmacokinetic (PBPK) Modeling for Predicting Drug-Food Interactions: an Industry Perspective
The effect of food on pharmacokinetic properties of drugs is a commonly observed occurrence affecting about 40% of orally administered drugs.
Using chemical structure information to develop predictive models for in vitro toxicokinetic parameters to inform high-throughput risk-assessment
The toxicokinetic (TK) parameters fraction of the chemical unbound to plasma proteins and metabolic clearance are critical for relating exposure and internal...