Concentration Profiles of Carvedilol: A Comparison Between In Vitro Transfer Model and Dissolution Testing
The study aims to investigate the transfer behavior of the weakly basic BCS class II model drug carvedilol from the stomach to the small intestine and compare the concentration profiles of carvedilol that...
Design, Synthesis, and Evaluation of Novel L-phenylglycine Derivatives as Potential PPARγ Lead Compounds
In accordance with the structural characteristics of thiazolidinedione drugs and highly bioactive tyrosine derivatives, we tentatively designed the l-phenylglycine derivatives TM1and TM2 based on basic…
Utility of physiologically based pharmacokinetic (PBPK) modeling in oncology drug development and its accuracy: a systematic review
Physiologically based pharmacokinetic (PBPK) modeling, a mathematical modeling approach which uses a pharmacokinetic model to mimick human physiology to predict drug...
Inquiry of Literature Evidence for Induced Fit of Cytochrome P450 2C9 for Warfarin, Phenprocoumon, Flurbiprofen and Clopidogrel: A Critical Review
Cytochrome P450 oxygenases (CYP for short) are liver microsomal enzymes with a prosthetic hem(e) group that catalyze various types of hepatic biotransformation reactions including aromatic and...
Simulations Plus to Report Third Quarter 2018 Financial Results
Simulations Plus, Inc. (Nasdaq: SLP), announced today that it will report its third quarter financial results for fiscal year 2018, the period ended May 31, 2018, after the close of the financial markets on Tuesday, July 10, 2018.
Biopharmaceutical considerations in paediatrics with a view to the evaluation of orally administered drug products – a PEARRL review
In this review, the current biopharmaceutical approaches for evaluation of oral formulation performance in paediatrics are discussed.
Population Pharmacokinetics and Exposure-Response Analyses of Eslicarbazepine Acetate Efficacy and Safety in Monotherapy of Partial-Onset Seizures.
Eslicarbazepine acetate (ESL) is a once-daily oral antiepileptic drug (AED) indicated for partial-onset seizures (POS). ESL pharmacokinetics (PK) and exposure-response analyses were supported by...
The role of peroxisome proliferator-activated receptor gamma in prostate cancer
Despite great progress in the detection and treatment of prostate cancer, this disease remains an incredible health and economic burden. Although androgen receptor (AR)...
Ethanolic Extract of Pomegranate (Punica Granatum L) Peel: Acute Toxicity Tests on Zebrafish (Danio rerio) Embryos and its Toxicity Prediction by in silico
Antibiotic resistance causes many serious health problems that have emerged both in developed and developing countries. One of many examples of the antibiotic problem is resistance to Mycobacterium…
Relationship Between Fremanezumab Exposure and Efficacy in Preventive Therapy of Chronic Migraine in Adults
Fremanezumab is a fully humanized IgG2Δa/kappa monoclonal antibody that selectively targets calcitonin gene-related peptide (CGRP).
Relationship Between Fremanezumab Exposure and Efficacy in Preventive Therapy of Episodic Migraine in Adults
Fremanezumab is a fully humanized IgG2Δa/kappa monoclonal antibody that selectively targets calcitonin gene-related peptide (CGRP).
Lack of Relationship Between Fremanezumab Exposure and Cardiovascular Adverse Events in Phase 2 and Phase 3 Data Including Chronic and Episodic Migraine Patients
Fremanezumab is a fully humanized IgG2Δa/kappa monoclonal antibody that selectively targets calcitonin gene-related peptide (CGRP). Previously, fremanezumab was found to be effective and…
Applying MAM/PBPK Modeling to Predict Positive/Negative Food Effects: Approaches and Special Considerations
It is widely recognized that food can affect the absorption of orally administered drugs. In the course of pharmaceutical development, food is evaluated clinically as part of the early single or multiple ascending dose studies; additional evaluations often take place when there are formulation changes. The outcome of these studies informs dosing instructions both during the conduct of clinical trials as well as on the product label.
Simulations Plus Releases ADMET Predictor™ Version 9
Improvements to AI technology and extensions to HTPK Simulation Module further support discovery research efforts
Food for thought: formulating away the food effect – a PEARRL review
Co‐ingestion of oral dosage forms with meals can cause substantial changes in bioavailability relative to the fasted state. Food‐mediated effects on bioavailability can have significant consequences...
In vitro methods to assess drug precipitation in the fasted small intestine – a PEARRL review
Drug precipitation in vivo poses a significant challenge for the pharmaceutical industry.
Simulations Plus Names Shawn O’Connor as CEO
Executive with relevant expertise in multiple industries succeeds retiring CEO Walt Woltosz, who remains chairman of the board
Pharmacokinetic/Pharmacodynamic Model of CW002, an Investigational Intermediate Neuromuscular Blocking Agent, in Healthy Volunteers
CW002 is an investigational non-depolarizing, neuromuscular blocking agent with a rapid onset and intermediate duration of
Computational Toxicology Methods in Chemical Library Design and High-Throughput Screening Hit Validation
The discovery of molecular toxicity in a clinical drug candidate can have a significant impact on both the cost and timeline of the drug discovery process.