The development of extended-release dosage forms with adequate drug release is a challenge for pharmaceutical companies, mainly when the drug presents high solubility, as in Biopharmaceutics Classification System (BCS) class I.
Identification of environmental chemicals that activate p53 signaling after in vitro metabolic activation
Currently, approximately 80,000 chemicals are used in commerce.
An Enabling Formulation of a Weakly Basic Compound Guided by Physiologically Based Biopharmaceutics Modeling (PBBM)
Weakly basic compounds propose biopharmaceutics risks due to the possibility of precipitation out of solution when passing from the stomach to the intestine.
Considerations for Physiologically Based Modeling in Liver Disease: From Nonalcoholic Fatty Liver (NAFL) to Nonalcoholic Steatohepatitis (NASH)
Nonalcoholic fatty liver disease (NAFLD), representing a clinical spectrum ranging from nonalcoholic fatty liver (NAFL) to nonalcoholic steatohepatitis (NASH) is rapidly...
Chemical Reactivity and Optical and Pharmacokinetics Studies of 14 Multikinase Inhibitors and Their Docking Interactions Toward ACK1 for Precision Oncology
Activated Cdc42-associated kinase 1 (ACK1/TNK2) has a significant role in cell endocytosis, survival, proliferation, and migration.
April 2022 GastroPlus Newsletter
We continue to offer an outstanding schedule of workshops, webinars, and even opportunities to meet with us face to face in the coming weeks.
Structure-based 3D-Pharmacophore modeling to discover novel interleukin 6 inhibitors: An in silico screening, molecular dynamics simulations and binding free energy calculations
Interleukin 6 (IL-6) is a cytokine with various biological functions in immune regulation, hematopoiesis, and inflammation.
Simulations Plus Reports Second Quarter Fiscal 2022 Financial Results
Total revenue growth of 13%; Software revenue growth of 25%; Diluted Earnings Per Share (EPS) growth of 40%
Board of Directors announces quarterly dividend of $0.06 per share
A model-based approach to bridging plasma and dried blood spot concentration data for phase 3 verubecestat trials
In-clinic venous dried blood spot (DBS) pharmacokinetic (PK) sampling was incorporated into two phase 3 studies of verubecestat for
Physiologically Based Biopharmaceutics Model of Vildagliptin Modified Release (MR) Tablets to Predict In Vivo Performance and Establish Clinically Relevant Dissolution Specifications
The objective of the study was to predict pharmacokinetic (PK) and pharmacodynamic (PD) parameters of matrix-based modified release (MR) drug product of vildagliptin.
NOMINATING COMMITTEE CHARTER 2022
Revision: March 31, 2022
Purpose:
The Board of Directors has established a Nominating & Corporate Governance Committee (the “Committee”) whose purpose is to seek and nominate qualified candidates for election or appointment to Simulation Plus’s Board of Directors.
Sputum lipoarabinomannan (LAM) as a biomarker to determine sputum mycobacterial load: exploratory and model-based analyses of integrated data from four cohorts
Despite the high global disease burden of tuberculosis (TB), the disease caused by Mycobacterium tuberculosis (Mtb) infection, novel treatments remain an urgent medical need. Development efforts continue to
Design of Dual COX-2 and 5-LOX Inhibitors with Iron-Chelating Properties Using Structure-Based and Ligand-Based Methods
Background: Inflammation is a critical component of many disease progressions, such as malignancy, cardiovascular and rheumatic diseases.
PBK modelling of topical application and characterisation of the uncertainty of Cmax estimate: A case study approach
Combined with in vitro bioactivity data, physiologically based kinetic (PBK) models has increasing applications in next generation risk assessment for animal-free safety...
Applying Mechanistic Modeling to Predict Food Effects on Drugs: Approaches and Special Considerations
The focus of this webinar will be to discuss how physiological differences between fasted and fed states have been incorporated into mechanistic absorption (MAM) and physiologically based pharmacokinetic (PBPK) models to predict positive and negative food effects.
Exploratory Study on Lercanidipine Hydrochloride Polymorphism: pH-Dependent Solubility Behavior
Based on the recent publication from AAPS PharmSci Tech, this 60-minute webinar will showcase an example of the use of GastroPlus® to assess the risk and pharmacokinetic relevance of different solubility and particle size between crystal forms of a poorly water-soluble antihypertensive drug, for diverse physiological conditions.
An IQ Consortium Perspective on Connecting Dissolution Methods to In Vivo Performance: Analysis of an Industrial Database and Case Studies to Propose a Workflow
Assessment of bioperformance to inform formulation selection and development decisions is an important aspect of drug development.
Simulations Plus Receives $1.7 Million Grant for BIOLOGXsym™ Macromolecule Safety Software
SLP will partner with the University of Pittsburgh and its Liver-on-a-Chip platform