Population Pharmacokinetics and Exposure-Response Analyses of Eslicarbazepine Acetate Efficacy and Safety in Monotherapy of Partial-Onset Seizures.

Population Pharmacokinetics and Exposure-Response Analyses of Eslicarbazepine Acetate Efficacy and Safety in Monotherapy of Partial-Onset Seizures.

Publication: J Clin Pharmacol
Division: Cognigen

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...

Ethanolic Extract of Pomegranate (Punica Granatum L) Peel: Acute Toxicity Tests on Zebrafish (Danio rerio) Embryos and its Toxicity Prediction by in silico

Ethanolic Extract of Pomegranate (Punica Granatum L) Peel: Acute Toxicity Tests on Zebrafish (Danio rerio) Embryos and its Toxicity Prediction by in silico

Publication: J Appl Pharm Sci
Software: ADMET Predictor®

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…

Lack of Relationship Between Fremanezumab Exposure and Cardiovascular Adverse Events in Phase 2 and Phase 3 Data Including Chronic and Episodic Migraine Patients

Lack of Relationship Between Fremanezumab Exposure and Cardiovascular Adverse Events in Phase 2 and Phase 3 Data Including Chronic and Episodic Migraine Patients

Conference: AHS
Division: Cognigen

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

Applying MAM/PBPK Modeling to Predict Positive/Negative Food Effects: Approaches and Special Considerations

Authors: Parrott N, Heimbach T
Software: GastroPlus®
Division: Simulations Plus

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.

Food for thought: formulating away the food effect – a PEARRL review

Food for thought: formulating away the food effect – a PEARRL review

Publication: J Pharm Pharmacol
Software: GastroPlus®

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...

Pharmacokinetic/Pharmacodynamic Model of CW002, an Investigational Intermediate Neuromuscular Blocking Agent, in Healthy Volunteers

Pharmacokinetic/Pharmacodynamic Model of CW002, an Investigational Intermediate Neuromuscular Blocking Agent, in Healthy Volunteers

Publication: Anesthesiology
Division: Cognigen

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

Computational Toxicology Methods in Chemical Library Design and High-Throughput Screening Hit Validation

Authors: Hevener KE
Publication: Computational Toxicology
Software: MedChem Studio™

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.

Development of a Clinically Relevant Dissolution Method for Metaxalone Immediate Release Formulations Based on an IVIVC Model

Development of a Clinically Relevant Dissolution Method for Metaxalone Immediate Release Formulations Based on an IVIVC Model

Publication: Pharm Res
Software: GastroPlus®

The aim of the present work was to classify metaxalone according to the Biopharmaceutics Classification System (BCS), to develop a clinically relevant dissolution method that can be used to predict...

Antibacterial and antibiofilm activities of Prangos acaulis Bornm. extract against Streptococcus mutans: an in silico and in vitro study

Antibacterial and antibiofilm activities of Prangos acaulis Bornm. extract against Streptococcus mutans: an in silico and in vitro study

Publication: J Herbmed Pharmacol

Streptococcus mutans is a principal pathogenic agent in biofilm formation on the teeth surfaces and subsequently development of dental caries and plaque.