A client’s cardiopulmonary/respiratory team needed to develop, design, and execute a half-day Regional Advisory Board.
Opinion Leader Management
A client was new to the market and lacked knowledge of their customers and key opinion leaders (KOLs) in the field.
Competitive Intelligence
A global medical affairs client was stretched thin: their internal and field-based medical staff couldn’t be everywhere at once, and they needed help keeping on top of the material presented at key medical conferences.
Market Assessments and Insights
A client had an asset in clinical development that showed activity against multiple tumor types.
Faculty Training & Development
A client needed new patient cases to illustrate recent indication updates to their label. They also wanted to consolidate new and existing case studies into a single, streamlined guide with a new, updated look.
Selective Promotional and Creative
A client’s inflammation medical affairs team wanted to introduce their business unit as an emerging leader with a robust inflammation pipeline at annual global IBD and RA conferences.
NAFLD Enrollment Support
Nonalcoholic Fatty Liver Disease, or NAFLD, studies present unique enrollment challenges that Pro-ficiency directly addresses.
Effect of Hepatic Impairment on Trofinetide Exposures Using an In Silico Physiologically Based Pharmacokinetic Model
Trofinetide is the first drug to be approved for the treatment of Rett syndrome.
Advancing Virtual Bioequivalence for Orally Administered Drug Products: Methodology, Real-World Applications and Future Outlook
Bioequivalence studies are pivotal in generic drug development wherein therapeutic equivalence is provided with an innovator product.
Simulations Plus Reports Third Quarter Fiscal 2024 Financial Results
Total revenue of $18.5 million and diluted earnings per share (EPS) of $0.15
Maintains full-year revenue guidance of $69 to $72 million and updates EPS guidance
The Synthetic Cathinones MDPHP and MDPV: Comparison of the Acute Effects in Mice, in silico ADMET Profiles and Clinical Reports
The 3,4-methylenedioxy-alpha-pyrrolidinohexanophenone (MDPHP) is a synthetic cathinone closely related to 3,4-methylenedioxypyrovalerone (MDPV), one of the most common synthetic cathinones present in the "bath salts".
Toward Personalized Salbutamol Therapy: Validating Virtual Patient-Derived Population Pharmacokinetic Model with Real-World Data
Interindividual variability, influenced by patient-specific factors including age, weight, gender, race, and genetics, among others, contributes to variations in therapeutic response.
Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report
This Article shares the proceedings from the August 29th, 2023 (day 1) workshop “Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives”.
DILIsym® X Product Brochure
DILIsym is Quantitative Systems Toxicology (QST) software capable of predicting and explaining Drug-Induced Liver Injury (DILI).
Treating Systemic Lupus Erythematosus: How QSP Can Support Drug Development & Clinical Trial Design
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease that affects more than five million people worldwide.
Best of both worlds: An expansion of the state of the art pKa model with data from three industrial partners
In a unique collaboration between Simulations Plus and several industrial partners, we were able to develop a new version 11.0 of the previously published in silico pKa model, S+pKa, with considerably improved prediction accuracy
Prediction of Disease Progression and Clinical Response in Systemic Sclerosis: Experience From a Proof-of-Concept Trial
Using the modified Rodnan skin score (mRSS) as a surrogate for disease activity, a phase 2a study in patients with systemic sclerosis (SSc) measured efficacy of the autotaxin inhibitor ziritaxestat.
Assessing the Anticholinergic Cognitive Burden Classification of Putative Anticholinergic Drugs Using Drug Properties
This study evaluated the use of machine learning to leverage drug absorption, distribution, metabolism and excretion (ADME) data together with physicochemical and pharmacological data to develop a novel anticholinergic burden scale and compare its performance to previously published scales.
Application of Mechanistic Pharmacokinetic Model for the Optimization of Metformin Delayed Release Dosage Form for Intestinal Targeting
Metformin (MET) is a widely prescribed drug for managing Type 2 Diabetes Mellitus (T2DM). Despite the rich clinical experience and advantages, the clinical utility of MET in renal failure patients is limited because of the treatment-related side effects.