Global testing of a consensus solubility assessment to enhance robustness of the WHO biopharmaceutical classification system

Global testing of a consensus solubility assessment to enhance robustness of the WHO biopharmaceutical classification system

Publication: ADMET DMPK

The WHO Biopharmaceutical Classification System (BCS) is a practical tool to identify active pharmaceutical ingredients (APIs) that scientifically qualify for...

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