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Simulations Plus Releases DILIsym® 11
Newest version of the quantitative systems toxicology (QST) software supports drug-induced liver injury (DILI) prediction for pediatric patient populations
Drug-Induced Liver Injury: A Look at QST Modeling and AI Predictions
As AI tools gain traction in drug development, there is growing enthusiasm around their potential to predict drug-induced liver injury (DILI).
Beyond the Linear Model in Concentration-QT Analysis
The white-paper regression model is the standard method for assessing QT liability of drugs.
Smarter Clinical Development: How to Use QSP to Maximize the Value of GLP-1 Agonists
As the market for GLP-1 agonists expands, biotech companies face both immense opportunity and fierce competition. To stand out in this evolving landscape and enhance the likelihood of acquisition or out-licensing, early-stage companies must develop a strategic, data-driven clinical development plan.
A well-characterized mechanistic model for exploring known or hypothesized T cell mediated drug induced liver injury: current capabilities and challenges for future predictivity
Drug-induced liver injury (DILI) is an adverse event whose emergence can slow or halt drug development programs.
Phasing Out Animal Testing: Responding to FDA and EMA’s Strategic Shifts
Both the U.S. Food and Drug Administration (FDA) (1) and the European Medicines Agency (EMA) (2) have articulated clear regulatory expectations for the implementation and advancement of non-animal methods, known as new approach methodologies (NAMs).
Role of Physiologically Based Biopharmaceutics Modeling in Predicting and Circumventing the Drug-Drug Interactions of Tyrosine Kinase Inhibitors with Acid-Reducing Agents
Tyrosine kinase inhibitors (TKIs) are molecular targeting agents used to treat various types of cancer. During the treatment with TKIs, acid-reducing agents (ARAs) are prescribed to prevent gastric mucosal damage.
Role of Physiologically Based Biopharmaceutics Modeling in Predicting and Circumventing the Drug-Drug Interactions of Tyrosine Kinase Inhibitors with Acid-Reducing Agents
Tyrosine kinase inhibitors (TKIs) are molecular targeting agents used to treat various types of cancer.
Evaluation of Violacein Metabolic Stability and Metabolite Identification in Human, Mouse, and Rat Liver Microsomes
Malaria significantly impacts the health of populations living in poverty and vulnerable conditions. Resistance to current antimalarial drugs remains a major challenge and highlights the urgent need for novel, effective, and safer therapies.
Clinical Pharmacology Considerations and Application of Model-Informed Drug Development in the Development of Drugs and Biological Products for Rare Diseases
The challenges of developing drug and biological products for rare diseases
Mastering DDI Risk Assessment: Navigate complexities of transporter-mediated DDIs
Transporters play a critical role in drug absorption, distribution, and elimination, and their involvement in drug-drug interactions (DDIs) can lead to altered drug concentrations and unexpected adverse effects that hamper the effectiveness of the treatment.
Utilizing Physiologically Based Pharmacokinetic Models to Support Rational Medication in Chinese Elderly Population
China is undergoing a pronounced shift towards an aging society, wherein the elderly constitute a prominent demographic relying significantly on medications.
Focus Your Obesity Pipeline for Clinical Success: Delivering the Right Compound at the Right Dose for the Right Patient
Driving the development of your obesity drug assets efficiently is critical for success
Simulations Plus Supports New FDA Roadmap for Reducing Animal Testing in Preclinical Safety Studies
Modeling and simulation will be a key component for shift to non-animal methodologies
Introducing NAMVantage(TM), a flagship package offering PBPK and QSP professional services and regulatory strategy combined with built-in coaching and training
Design and Development of Sulfenylated 5-Aminopyrazoles as Inhibitors of Acetylcholinesterase and Butyrylcholinesterase: Exploring the Implication for Aβ1–42 Aggregation Inhibition in Alzheimer’s Disease
Current therapeutic regimens approved to treat Alzheimer's disease (AD) provide symptomatic relief by replenishing the acetylcholine levels in the brain by inhibiting AChE.
Formulation Strategy of BCS-II Drugs by Coupling Mechanistic In-Vitro and Nonclinical In-Vivo Data with PBPK: Fundamentals of Absorption-Dissolution to Parameterization of Modelling and Simulation
BCS class II candidates pose challenges in drug development due to their low solubility and permeability.
From In Vivo Predictive Dissolution to Virtual Bioequivalence: A GastroPlus®-Driven Framework for Generic Candesartan Cilexetil Tablets
Candesartan cilexetil, a Biopharmaceutics Classification System (BCS) II prodrug, demonstrates compromised bioavailability attributable to its limited aqueous solubility coupled with P-glycoprotein (P-gp)-mediated efflux and hepatic first-pass metabolism, thereby introducing complexities in generic drug bioequivalence assessments.
Mode of Action Approach Supports a Lack of Carcinogenic Potential of Six Organic UV Filters
Ultraviolet (UV) filters, the active ingredients in sunscreens, have been used for several decades to reduce the risk of acute and chronic damage to the skin from solar UV radiation, which can lead to skin cancer.
Mode of Action Approach Supports a Lack of Carcinogenic Potential of Six Organic UV Filters
Ultraviolet (UV) filters, the active ingredients in sunscreens, have been used for several decades to reduce the risk of acute and chronic damage to the skin from solar UV radiation, which can lead to skin cancer.