Review of the pharmacokinetics and metabolism of triclopyr herbicide in mammals: Impact on safety assessments

Review of the pharmacokinetics and metabolism of triclopyr herbicide in mammals: Impact on safety assessments

Publication: Regul Toxicol Pharmacol
Software: GastroPlus®

A review of pharmacokinetic and metabolism studies show that triclopyr is well absorbed from the oral route in numerous species...

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: PBPK

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)

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...