Computer simulations using GastroPlus to justify a biowaiver for etoricoxib solid oral drug products

Computer simulations using GastroPlus to justify a biowaiver for etoricoxib solid oral drug products

Publication: Eur J Pharm Biopharm
Software: GastroPlus®

The purpose of this study was to compare the dissolution behaviour of etoricoxib in different dissolution media and to establish in vitro/in vivo correlation (IVIVC) using computer simulations.

Non-competitive androgen receptor inhibition in vitro and in vivo

Non-competitive androgen receptor inhibition in vitro and in vivo

Publication: Proc Natl Acad Sci USA
Division: PBPK

Androgen receptor (AR) inhibitors are used to treat multiple human diseases, including hirsutism, benign prostatic hypertrophy, and prostate cancer, but all available...

Kerfuffle!

Kerfuffle!

Publication: J Clin Pharmacol

To become disheveled. A kerfuffle is the polite term for a cascading series of errors that can be initiated by a seemingly innocuous event that then leads to other...

Development of a Steady-State Exposure-Response Model for Exenatide Once Weekly

Development of a Steady-State Exposure-Response Model for Exenatide Once Weekly

Conference: ASCPT

Exenatide is dosed as a subcutaneous (SC) injection of 5 and 10 μg twice daily (BID) before main meals and is indicated for the treatment of type 2 diabetes mellitus in patients failing to achieve adequate…

Calculation of molecular lipophilicity: State-of-the-art and comparison of log P methods on more than 96,000 compounds

Calculation of molecular lipophilicity: State-of-the-art and comparison of log P methods on more than 96,000 compounds

Publication: J Pharm Sci
Software: ADMET Predictor®

We first review the state-of-the-art in development of log P prediction approaches falling in two major categories: substructure-based and property-based methods.

Application of patient population-derived pharmacokinetic-pharmacodynamic relationships to tigecycline breakpoint determination for staphylococci and streptococci

Application of patient population-derived pharmacokinetic-pharmacodynamic relationships to tigecycline breakpoint determination for staphylococci and streptococci

Correctly determined susceptibility breakpoints are important to both the individual patient and to society at large. A previously derived patient population...

Toward an In Vivo Dissolution Methodology: A Comparison of Phosphate and Bicarbonate Buffers

Toward an In Vivo Dissolution Methodology: A Comparison of Phosphate and Bicarbonate Buffers

Publication: Mol Pharm
Software: ADMET Predictor®

The purpose of this research was to evaluate the difference between the pharmaceutical phosphate buffers and the gastrointestinal bicarbonates in dissolution of ketoprofen and indomethacin...

Analysis of Risk Factors in Human Bioequivalence Study That Incur Bioinequivalence of Oral Drug Products

Analysis of Risk Factors in Human Bioequivalence Study That Incur Bioinequivalence of Oral Drug Products

Publication: Mol Pharm
Software: ADMET Predictor®

In the study of human bioequivalence (BE), newly developed oral products sometimes fail to prove BE with a reference product due to the high variability in pharmacokinetic (PK)...

Busting the Black Box Myth: Designing Out Unwanted ADMET Properties with Machine Learning Approaches

Busting the Black Box Myth: Designing Out Unwanted ADMET Properties with Machine Learning Approaches

Publication: CICSJ Bulletin
Software: ADMET Predictor®
Division: PBPK

Drug design is usually understood as “an inventive process of finding new medications based on the knowledge of the biological target” – according to the...

Omeprazole: Physiologically Based Pharmacokinetic (PBPK) Modeling and Prediction of Drug-Drug Interactions (DDI)

Omeprazole: Physiologically Based Pharmacokinetic (PBPK) Modeling and Prediction of Drug-Drug Interactions (DDI)

Conference: AAPS
Division: PBPK

To optimize a PBPK model of omeprazole for prediction of DDIs with respect to polymorphic expression of CYP enzymes. Omeprazole absorption and pharmacokinetics were simulated using GastroPlus™.