Applying MAM/PBPK Modeling to Predict Positive/Negative Food Effects: Approaches and Special Considerations

Applying MAM/PBPK Modeling to Predict Positive/Negative Food Effects: Approaches and Special Considerations

Authors: Parrott N, Heimbach T
Software: GastroPlus®
Division: PBPK

It is widely recognized that food can affect the absorption of orally administered drugs. In the course of pharmaceutical development, food is evaluated clinically as part of the early single or multiple ascending dose studies; additional evaluations often take place when there are formulation changes. The outcome of these studies informs dosing instructions both during the conduct of clinical trials as well as on the product label.

Food for thought: formulating away the food effect – a PEARRL review

Food for thought: formulating away the food effect – a PEARRL review

Publication: J Pharm Pharmacol
Software: GastroPlus®

Co‐ingestion of oral dosage forms with meals can cause substantial changes in bioavailability relative to the fasted state. Food‐mediated effects on bioavailability can have significant consequences...

Computational Toxicology Methods in Chemical Library Design and High-Throughput Screening Hit Validation

Computational Toxicology Methods in Chemical Library Design and High-Throughput Screening Hit Validation

Authors: Hevener KE
Publication: Computational Toxicology
Software: MedChem Studio™

The discovery of molecular toxicity in a clinical drug candidate can have a significant impact on both the cost and timeline of the drug discovery process.

Development of a Clinically Relevant Dissolution Method for Metaxalone Immediate Release Formulations Based on an IVIVC Model

Development of a Clinically Relevant Dissolution Method for Metaxalone Immediate Release Formulations Based on an IVIVC Model

Publication: Pharm Res
Software: GastroPlus®

The aim of the present work was to classify metaxalone according to the Biopharmaceutics Classification System (BCS), to develop a clinically relevant dissolution method that can be used to predict...

Antibacterial and antibiofilm activities of Prangos acaulis Bornm. extract against Streptococcus mutans: an in silico and in vitro study

Antibacterial and antibiofilm activities of Prangos acaulis Bornm. extract against Streptococcus mutans: an in silico and in vitro study

Publication: J Herbmed Pharmacol

Streptococcus mutans is a principal pathogenic agent in biofilm formation on the teeth surfaces and subsequently development of dental caries and plaque.

In silico approach in reveal traditional medicine plants pharmacological material basis

In silico approach in reveal traditional medicine plants pharmacological material basis

Publication: Chin Med
Software: ADMET Predictor®

In recent years, studies of traditional medicinal plants have gradually increased worldwide because the natural sources and variety of such plants allow them to complement modern pharmacological approaches.

Exploring gastric emptying rate in minipigs: Effect of food type and pre-dosing of metoclopramide

Exploring gastric emptying rate in minipigs: Effect of food type and pre-dosing of metoclopramide

Publication: Eur J Pharm Sci
Software: GastroPlus®

The present study investigated the gastric emptying rate in Göttingen minipigs pre- and post-prandial and evaluated the effect of metoclopramide on the same parameter, using paracetamol as an absorption marker.

THU0549 Absence of Association Between Drug Exposure and Infection in Patients With Polyarticular-Course Juvenile Idiopathic Arthritis and Inadequate Response to Biologic or Non-Biologic DMARDS Treated With SC and IV Abatacep

THU0549 Absence of Association Between Drug Exposure and Infection in Patients With Polyarticular-Course Juvenile Idiopathic Arthritis and Inadequate Response to Biologic or Non-Biologic DMARDS Treated With SC and IV Abatacep

Publication: Annals of the Rheumatic Diseases

Background Infections are the most common expected AEs linked to biologic (b) DMARDs in paediatric patients (pts) with juvenile idiopathic arthritis (JIA). Blood concentrations achieved with bDMARDs vary greatly between...