Simulations Plus to Participate in the Stephens Annual Investment Conference
Liver Safety+ Flyer
The only platform that allows you to predict liver safety during discovery
Hansen parameters and GastroPlus assisted optimized topical elastic liposomes to treat breast cancer using a novel isatin derivative
Breast cancer treatment is a global health challenge using conventional toxic chemotherapeutic agents.
Demonstrating Discriminatory Power of a Dissolution Method Using DDDPlus: Case Study of an ExtendedRelease Formulation and Use in Regulatory Justifications
Dissolution testing is an important attribute that provides insight into in vivo performance, batch-tobatch uniformity and consistent clinical quality.
Identification, Characterization, and in silico ADMET Prediction of Nirmatrelvir and its Degradation Products Using HPLC-PDA and LC-QTOF-MS/MS
Nirmatrelvir is a protease inhibitor that is essential for virus replication. Nirmatrelvir is indicated for the management of mild to severe cases of COVID-19 in individuals who are 12 years of age or older.
What You Need to Know About Using PBPK Modeling for DDI Interaction Assessments for GLP-1 Agonists
GLP-1 agonists have become a crucial component in the treatment of metabolic disorders like type 2 diabetes and obesity.
Simulations Plus and Partners Awarded New FDA Grant to Validate In Vitro-In Vivo Extrapolation Methods for Complex Formulations
Collaboration goal to develop alternative methods to assess clinical performance of product variants under different conditions
Mechanistic Representation of Clusterin, a Damage Biomarker for Early Detection of Drug-induced AKI
Novel biomarkers have the potential to address early diagnosis and...
Machine learning driven bioequivalence risk assessment at an early stage of generic drug development
Bioequivalence risk assessment as an extension of quality risk management lacks examples of quantitative approaches to risk assessment at an early stage of generic drug development.
Discovery and Characterization of BAY-184: A New Potent and Selective Acylsulfonamide-Benzofuran In Vivo-Active KAT6AB InhibitorCli
KAT6A and KAT6B genes are two closely related lysine acetyltransferases that transfer an acetyl group from acetyl coenzyme A (AcCoA) to lysine residues of target histone substrates, hence playing a key role in chromatin regulation.
Developing a Screening Strategy to Identify Hepatotoxicity and Drug Interaction Potential of Botanicals
Botanical supplements, herbal remedies, and plant-derived products are used globally. However, botanical dietary supplements are rarely subjected to robust safety testing unless there are adverse reports in post-market surveillance.
Orforglipron Weight Loss and Nausea Accurately Simulated with OBESITYsym
The recent availability of effective, GLP-1R agonist (GLP-1RA) based treatments of obesity has provided great benefit to patients
Using PBPK to Establish In Vitro-In Vivo Relationship for Budesonide Delayed Release Oral Drug Product
Budesonide is a corticosteroid used to treat inflammatory bowel diseases (IBD) (1)
PK/PD Modeling Made Simple
Modeling is increasingly important for the speed and success of our drug development programs, but the learning curve to be effective can be high.
Delineating the Role of Transporters in the Absorption and Disposition of Digoxin Using the Physiologically Based Pharmacokinetic (PBPK) Modeling
Digoxin (DIG) is one of the cardiac glycosides that inhibits sodium-potassium ATPase, an enzyme that regulates the intracellular concentration of sodium and potassium.
Enhanced PBPK-Based In Vitro to In Vivo Extrapolation Method to Support the Development of Pulmonary Drug Products
Orally inhaled drug products (OIDPs) are used to treat pulmonary diseases. OIDP absorption occurs in three phases: deposition, dissolution, and permeation.
Mechanistic in vitro Oral Absorption Model to Predict Mucosal Permeability of Oral Cavity Drug Products
Buccal delivery allows patient compliance, ease of drug administration and potential bypass of first-pass metabolism
Practical tips for using GenAI in Biomedicine
Now that we a are couple of years into the age of generative AI, it’s clear that it is transforming scientific research and drug discovery.
Mechanistic Model of in vitor Intraoral Absorption of Buprenorphine for the Buccal and Gingival Mucosa
Long-term use of buprenorphine oral cavity drug products (DP) poses risks of dental issues [1] and the underlying reason is not well understood