Assessing the Role of Intracellular Binding Protein in Drug-Induced Bile Acid Transporter Inhibition Using Quantitative Systems Pharmacology (QSP) Modeling

Assessing the Role of Intracellular Binding Protein in Drug-Induced Bile Acid Transporter Inhibition Using Quantitative Systems Pharmacology (QSP) Modeling

Conference: AAPS
Software: DILIsym®

Bile acid transporter inhibition has been shown to be an important mechanism of drug-induced liver injury (DILI), but the biophase responsible for the transporter inhibition is unclear.

A PBPK model of the negative effect of chitosan on acyclovir absorption: The mucus-chitosan interaction

A PBPK model of the negative effect of chitosan on acyclovir absorption: The mucus-chitosan interaction

Conference: AAPS
Software: GastroPlus®
Division: PBPK

A recent bioavailability study raises questions about the universality of the permeability enhancing effect of chitosan on poorly permeable drugs.

HTPK: Conducting PK modeling and simulations at high speed

HTPK: Conducting PK modeling and simulations at high speed

Conference: AAPS
Software: ADMET Predictor®
Division: PBPK

In silico pharmacokinetic (PK) simulations are now routinely incorporated into drug development workflows, especially in the later stages.

HTPK: Conducting PK modeling and simulations at high speed

HTPK: Conducting PK modeling and simulations at high speed

Conference: AAPS
Division: PBPK

HTPK lightens the burden of collecting and preparing input variables for full blown PK simulations by using structure-based predictions.

Using in-silico Models to Integrate in-vitro Data to Support Virtual Trials for Cost Effective Drug Development

Using in-silico Models to Integrate in-vitro Data to Support Virtual Trials for Cost Effective Drug Development

Authors: Lukacova V
Conference: AAPS
Software: GastroPlus®
Division: PBPK

PBPK models allow incorporating different types of in vitro measurements into single platform to account for all processes affecting drug’s absorption, distribution and elimination.

Application of a Dynamic Fluid & pH Model to Simulate Intraluminal and Systemic Concentrations of a Weak Base in GastroPlus™

Application of a Dynamic Fluid & pH Model to Simulate Intraluminal and Systemic Concentrations of a Weak Base in GastroPlus™

Authors: Hens B, Bolger MB
Publication: J Pharm Sci
Division: PBPK

The application of preclinical in vitro and in silico models can help formulation scientists to predict the in vivo performance of a drug in an early stage of oral drug product development.

Using Quantitative Systems Toxicology to Investigate Observed Species Differences in CKA-Mediated Hepatotoxicity

Using Quantitative Systems Toxicology to Investigate Observed Species Differences in CKA-Mediated Hepatotoxicity

Publication: Toxicol Sci
Software: DILIsym®

CKA, a chemokine receptor antagonist intended for treating inflammatory conditions, produced dose-dependent hepatotoxicity in rats but advanced into the clinic where single doses of CKA up to 600 mg appeared safe in humans.

Nonclinical pharmacokinetics and in vitro metabolism of H3B-6545, a novel selective ERα covalent antagonist (SERCA)

Nonclinical pharmacokinetics and in vitro metabolism of H3B-6545, a novel selective ERα covalent antagonist (SERCA)

Publication: Cancer Chemother Pharmacol
Software: GastroPlus®

H3B-6545, a novel selective estrogen receptor (ER)α covalent antagonist (SERCA) which inactivates both wild-type and mutant ERα, is in clinical development for the treatment of metastatic breast cancer.

Synthesis, Molecular Docking, and Antimycotic Evaluation of Some 3-Acyl Imidazo[1,2-a]pyrimidines

Synthesis, Molecular Docking, and Antimycotic Evaluation of Some 3-Acyl Imidazo[1,2-a]pyrimidines

Publication: Molecules

A series of 3-benzoyl imidazo[1,2-a]pyrimidines, obtained from N-heteroarylformamidines in good yields, was tested in silico and in vitro for binding and inhibition of seven Candida species...

Applying GastroPlus Modeling Establish Level A IVIVCs Waive Biostudies

Applying GastroPlus Modeling Establish Level A IVIVCs Waive Biostudies

Authors: Novakovic J
Software: GastroPlus®
Division: PBPK

Bioavailability/bioequivalence (BA/BE) evaluation by employing in vitro dissolution/release data and clinically relevant specification is required by the regulators. For BCS 1/BCS 3 drugs formulated as immediate release (IR) oral dosage forms, a BCS-based biowaiver may be granted based on the in vitro dissolution profiles generated across the physiologically relevant pH range. For drugs/formulations with dissolution/release limited/controlled absorption, establishing Level A in vitro – in vivo correlations (IVIVCs) can be applied and further utilized to assess whether BA/BE is recommended.

ETCM: an encyclopaedia of traditional Chinese medicine

ETCM: an encyclopaedia of traditional Chinese medicine

Publication: Nucleic Acids Res
Software: MedChem Studio™

Traditional Chinese medicine (TCM) is not only an effective solution for primary health care, but also a great resource for drug innovation and discovery.