Policy of Multisource Drug Products in Latin America: Opportunities and Challenges on the Application of Bioequivalence In Vitro Assays

Policy of Multisource Drug Products in Latin America: Opportunities and Challenges on the Application of Bioequivalence In Vitro Assays

Publication: Ther Innov Regul Sci
Division: Simulations Plus

Background: The replacement of traditional in vivo bioequivalence studies by in vitro dissolution assays, based on the biopharmaceutical classification system (BCS), has...

Pediatric dose selection for fremanezumab (AJOVY) phase 3 migraine study using  pharmacokinetic data from  a pediatric phase 1 study and a population pharmacokinetic modeling and simulation approach

Pediatric dose selection for fremanezumab (AJOVY) phase 3 migraine study using  pharmacokinetic data from  a pediatric phase 1 study and a population pharmacokinetic modeling and simulation approach

Conference: European Headache Federation (EHF)
Division: Cognigen

Previous examination of the relationship between fremanezumab exposures and baseline body weight supports a weight cutoff of 45 kg of pediatric dose selection, with the approved adult dose of 225 mg monthly being appropriate or patients weighing >= 45 kg

Biopharmaceutical characterization of rebamipide: The role of mucus binding in regional-dependent intestinal permeability

Biopharmaceutical characterization of rebamipide: The role of mucus binding in regional-dependent intestinal permeability

Publication: Eur J Pharm Sci
Software: GastroPlus®

In this study, we aimed to elucidate biopharmaceutical characteristics of the anti-ulcer drug rebamipide, with special emphasis on the...

Application of synthetic membranes in establishing bio-predictive IVPT for testosterone transdermal gel

Application of synthetic membranes in establishing bio-predictive IVPT for testosterone transdermal gel

Publication: Int J Pharm
Software: GastroPlus®

The current study investigated the use of synthetic membranes in developing a bio-predictive in vitro permeation testing (IVPT) method for 1.62% testosterone gel.

Evaluation of the effect of synthetic compounds derived from azidothymidine on MDA-MB-231 type breast cancer cells

Evaluation of the effect of synthetic compounds derived from azidothymidine on MDA-MB-231 type breast cancer cells

Publication: Bioorg Med Chem Lett.
Software: ADMET Predictor®

The present study aimed to investigate the effect of AZT derivates containing tellurium (Te) on human breast cancer cell lines and the mechanisms...

In Vitro-In Silico Evaluation of Apremilast Solid Dispersions Prepared via Corotating Twin Screw Extruder

In Vitro-In Silico Evaluation of Apremilast Solid Dispersions Prepared via Corotating Twin Screw Extruder

Publication: J Drug Deliv Sci Technol

The purpose of this study was to employ the Hot melt extrusion technique (HME) to prepare amorphous solid dispersions (ASDs) of Apremilast, a BCS class IV drug.

Developing HME-Based Drug Products Using Emerging Science: a Fast-Track Roadmap from Concept to Clinical Batch

Developing HME-Based Drug Products Using Emerging Science: a Fast-Track Roadmap from Concept to Clinical Batch

Publication: AAPS PharmSciTech
Software: GastroPlus®

This paper presents a rational workflow for developing enabling formulations, such as amorphous solid dispersions, via hot-melt...

The AHR1-ARNT1 dimerization pair is a major regulator of the response to natural ligands, but not to TCDD, in the chicken

The AHR1-ARNT1 dimerization pair is a major regulator of the response to natural ligands, but not to TCDD, in the chicken

Publication: Ecotoxicology and Environmental Safety

The activation of the aryl hydrocarbon receptor (AHR) occurs through the binding of dioxin-like compounds (DLCs) or natural ligands.

The application of machine learning techniques to innovative antibacterial discovery and development

The application of machine learning techniques to innovative antibacterial discovery and development

Publication: Expert Opin Drug Discov
Software: ADMET Predictor®

After the initial wave of antibiotic discovery, few novel classes of antibiotics have emerged, with the latest dating back to the 1980’s.