A Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union

A Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union

Publication: Clin Pharmacol Ther

The current regulatory criterion for bioequivalence of narrow therapeutic index (NTI) drugs in the European Union requires that the 90% confidence interval for the ratio of the population geometric means of the test product compared with the reference for area under the plasma concentration-time curve (AUC), and in certain cases maximum plasma drug concentration (Cmax ), to be included within the tighter acceptance range of 90.00-111.11%.

Estimators and Confidence Intervals of f 2 Using Bootstrap Methodology for the Comparison of Dissolution Profiles

Estimators and Confidence Intervals of f 2 Using Bootstrap Methodology for the Comparison of Dissolution Profiles

Publication: Comput Methods Programs Biomed

The most widely used method to compare dissolution profiles is the similarity factor f2. When this method is not applicable, the confidence interval of f2 using bootstrap methodology has been recommended instead.

The evaluation of the effect of different superdisintegrants on the drug release from FDM 3D printed tablets through different applied strategies: In vitro-in silico assessment

The evaluation of the effect of different superdisintegrants on the drug release from FDM 3D printed tablets through different applied strategies: In vitro-in silico assessment

Publication: Int J Pharm
Software: GastroPlus®

Paracetamol-loaded tablets were printed by fused deposition modelling technique, using polyvinyl alcohol as a backbone polymer and Affinisol™ HPMC as a plasticizer in all formulations.

Pharmacokinetics of asciminib in the presence of CYP3A or P-gp inhibitors, CYP3A inducers, and acid-reducing agents

Pharmacokinetics of asciminib in the presence of CYP3A or P-gp inhibitors, CYP3A inducers, and acid-reducing agents

Publication: Clin Transl Sci
Software: GastroPlus®

Asciminib is a first-in-class inhibitor of BCR::ABL1, specifically targeting the ABL myristoyl pocket. Asciminib is a substrate of CYP3A4 and P-glycoprotein (P-gp) and possesses pH-dependent solubility in aqueous solution.

Physiologically Based Pharmacokinetic Modeling of Oxycodone in Children to Support Pediatric Dosing Optimization

Physiologically Based Pharmacokinetic Modeling of Oxycodone in Children to Support Pediatric Dosing Optimization

Publication: Pharm Res
Software: PKanalix®

Physiologically-based pharmacokinetic (PBPK) modeling offers a unique modality to predict age-specific pharmacokinetics.

In silico bioavailability for BCS class II efavirenz tablets using biorelevant dissolution media for IVIVR and simulation of formulation changes

In silico bioavailability for BCS class II efavirenz tablets using biorelevant dissolution media for IVIVR and simulation of formulation changes

Publication: Drug Dev Ind Pharm

This work aims to evaluate the ability of biorelevant dissolution media to simulate the bioavailability of efavirenz tablets, establish an in vitro–in vivo relationship (IVIVR) based on in...

PBPK Modeling and Simulation of Antibiotics Amikacin, Gentamicin, Tobramycin, and Vancomycin Used in Hospital Practice

PBPK Modeling and Simulation of Antibiotics Amikacin, Gentamicin, Tobramycin, and Vancomycin Used in Hospital Practice

Publication: Life (Basil)
Software: GastroPlus®

The importance of closely observing patients receiving antibiotic therapy, performing therapeutic drug monitoring (TDM), and regularly adjusting dosing regimens has been extensively demonstrated.

Animal metrics: Tracking contributions of new approach methods to reduced animal use

Animal metrics: Tracking contributions of new approach methods to reduced animal use

Publication: Altex
Software: GastroPlus®

Many companies and global regulatory programs have expressed the intent to move away from in vivo animal testing to new approach methods (NAMs) as part of product safety assessments.

Deep eutectic liquid as transdermal delivery vehicle of Risperidone

Deep eutectic liquid as transdermal delivery vehicle of Risperidone

Publication: Journal Molecular Liquids
Software: GastroPlus®

The work outlined herein describes an evaluation of a green solvent working as a drug solubility and penetration enhancer made up of a deep eutectic system (DES) composed of menthol (MN) and capric acid (CA).

Development of physiologically-based pharmacokinetic models for standard of care and newer tuberculosis drugs

Development of physiologically-based pharmacokinetic models for standard of care and newer tuberculosis drugs

Publication: CPT Pharmacometrics Syst Pharmacol
Software: GastroPlus®
Division: PBPK

Tuberculosis (TB) remains a global health problem and there is an ongoing effort to develop more effective therapies and new combination regimes that can reduce duration of treatment.

A new phenothiazine derivate is active against Clostridioides difficile and shows low cytotoxicity

A new phenothiazine derivate is active against Clostridioides difficile and shows low cytotoxicity

Publication: PLoS One
Software: GastroPlus®

The rapid evolution of antibiotic resistance in Clostridioides difficile and the consequent effects on prevention and treatment of C.

Slower degradation rate of cytarabine in blood samples from acute myeloid leukemia by comparison with control samples

Slower degradation rate of cytarabine in blood samples from acute myeloid leukemia by comparison with control samples

Publication: Cancer Chemother Pharmacol
Software: PKanalix®

Cytarabine, a key chemotherapy agent for acute myeloid leukemia (AML) treatment, is deaminated into inactive uracil-arabinoside by cytidine deaminase.