Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing acetazolamide are reviewed. Acetazolamide's solubility and permeability characteristics according to the Biopharmaceutics Classification System (BCS), as well as its therapeutic use and therapeutic index, its pharmacokine...

The objective of the current study was to develop mathematical models that described the pharmacokinetic behavior of prednisolone in healthy subjects after the oral administration of prednisolone. The current study is a companion piece of a related Leclercq and Copinsehi prednisolone study published in the February 1974 issue of the Journal of Pharmacokinetics and Biopharmaceutics. In the study...

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing cimetidine are reviewed. According to the current Biopharmaceutics Classification System (BCS), cimetidine would be assigned to Class III. Cimetidine's therapeutic use and therapeutic index, its pharmacokinetic properties...

Literature and new experimental data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing furosemide are reviewed. The available data on solubility, oral absorption, and permeability are sufficiently conclusive to classify furosemide into Class IV of the Biopharmaceutics Classification Sys...

This workshop report summarizes the proceedings of Day 1 a three-day on “Current State and Future Expectations Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes Controls”. Physiologically based biopharmaceutics models (PBBM) are tools which enable drug product quality attributes be linked in vivo performance. These rely key inputs order provide reliabl...

Biowaiver is a procedure for establishing the bioequivalence of generic and reference products without in vivo studies. Regulatory requirements this procedure, as described variety documents, differ certain features aspects. These differences need to be analysed. The aim study was compare international Russian regulatory approaches Biopharmaceutics Classification System-based biowaivers, provid...