Simulations Plus, Inc. (Nasdaq: SLP), announced today that it will report financial results for the first quarter of fiscal year 2022, the period ended November 30, 2021, after the close... January 6, 2022.
Lixoft Adds New Bioequivalence Module in MonolixSuite® Version 2021R1
Update includes enhanced PKanalix, Monolix, and Simulx modules
Dissolution Challenges Associated with the Surface pH of Drug Particles: Integration into Mechanistic Oral Absorption Modeling
The present work aimed to differentiate between in vitro dissolution profiles of ibuprofen as input for GastroPlus™ and to see the impact on systemic exposure.
Population Pharmacokinetic Modeling and Exposure-Response Analysis for Aripiprazole Once Monthly in Subjects With Schizophrenia
An intramuscular formulation of aripiprazole monohydrate dosed once monthly (AOM) was developed to address nonadherence with
Preferential Solvation Study of the Synthesized Aldose Reductase Inhibitor (SE415) in the {PEG 400 (1) + Water (2)} Cosolvent Mixture and GastroPlus-Based Prediction
(Z)-N-Benzyl-2-{2,4-dioxo-5-(4-prop-2-yl-1-yloxyl)benzylidene)thiazolin-3-yl)}acetamide (SE415) is a novel aldose reductase inhibitor used in the management of diabetes mellitus (DM) and associated complications.
In Vitro and In Silico Study of Analogs of Plant Product Plastoquinone to Be Effective in Colorectal Cancer Treatment
Plants have paved the way for the attainment of molecules with a wide-range of biological activities.
Transition from Syringe to Autoinjector Based on Bridging Pharmacokinetics and Pharmacodynamics of the P2Y12 Receptor Antagonist Selatogrel in Healthy Subjects
Selatogrel is a potent, reversible, and selective antagonist of the platelet P2Y12 receptor currently developed for the treatment of acute myocardial infarction (AMI).
Level A IVIVC for immediate release tablets confirms in vivo predictive dissolution testing for ibuprofen
A bioequivalence study comparing two fixed dose combination tablets containing 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride showed bioequivalence for pseudoephedrine AUC and Cmax, but the reference product showed higher Cmax than the test product in fasted conditions.
Identification of phenylcarbamoylazinane-1,3,4-oxadiazole amides as lipoxygenase inhibitors with expression analysis and in silico studies
In search for new anti-inflammatory agents that inhibit the enzymes of arachidonic acid pathway as the drug targets, the present article describes the screening...
A novel chemical inhibitor suppresses breast cancer cell growth and metastasis through inhibiting HPIP oncoprotein
Increasing evidence suggests the pivotal role of hematopoietic pre-B-cell leukemia transcription factor (PBX)-interacting protein (HPIP/PBXIP1) in cancer development and progression...
Best practices in current models mimicking drug permeability in the gastrointestinal tract – an UNGAP review
The absorption of orally administered drug products is a complex, dynamic process, dependant on a range of biopharmaceutical properties; notably the aqueous solubility of a molecule, stability within the gastrointestinal tract (GIT) and permeability.
In Vitro and In Vivo Bioequivalence Study of 3D-Printed Instant-Dissolving Levetiracetam Tablets and Subsequent Personalized Dosing for Chinese Children Based on Physiological Pharmacokinetic Modeling
Recently, the development of Binder Jet 3D printing technology has promoted the research and application of personalized formulations, which are especially useful for children’s medications.
Exposure-Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
A benefit:risk assessment for a less-frequent nivolumab 480 mg Q4W + cabozantinib 40 mg QD dosing regimen was predicted using modeling and simulation of clinical trial data from nivolumab monotherapy studies and
A supramolecular thermosensitive gel of ketoconazole for ocular applications: In silico, in vitro, and ex vivo studies
The incidence of corneal fungal infections continues to be a growing concern worldwide.
Simulations Plus Sets Date for First Quarter Fiscal Year 2022 Earnings Release and Conference Call
Conference Call to be on Thursday, January 6, 2022, at 5:00 PM ET
Using PBPK M&S to support the development of an IR tablet formulation & setting more relevant dissolution test specifications
Development of formulation and setting dissolution test specifications for IR tablets based on PBPK modeling & simulation – amiodarone as a case example
December 2021 Gastroplus Newsletter
Happy Holidays from Dan O' Connor
Predicting the Drug–Drug Interaction Mediated by CYP3A4 Inhibition: Method Development and Performance Evaluation
The prediction of drug–drug interactions (DDIs) plays critical roles for the estimation of DDI risk caused by inhibition of CYP3A4.