Does this sound familiar? You are a pharmacometric modeler facing a tight deadline.
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.
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.
Transforming Clinical Trial Training for Enhanced Patient Trust
Patient trust is critical for ensuring adequate enrollment and retention of clinical trial participants.
Boosting Patient Safety with Risk-Free Adaptive Learning
Patient safety is paramount in any clinical trial.
The Case for PK Simulations in Early Drug Discovery
You’re the head of medicinal chemistry. Your focus is on developing molecules that balance (often conflicting) objectives to achieve the target compound profile, and it consumes every spare minute.
Getting Started with GPX™: A Step-by-Step Guide
With a new interface, updated workflows, and advanced features, it may be challenging to know how to get started with GastroPlus(R) X.
New ICH M13A Guideline: Extra Bioequivalence Study Needed for pH-Dependent Drugs with Proton Pump Inhibitors
New guidance was recently released by the International Council for Harmonisation (ICH) regarding bioequivalence for immediate release solid oral dosage forms.
Women in Science: Evelyn Haupt
In the biopharma industry, we often focus on scientific research and research methodologies. However, software design and usability is also vital in translating complex data and technologies into accessible and user-friendly solutions.
3 Clinical Quality Problems That Simulation Training Solves
Want to see fewer protocol deviations and agile change management in your clinical trials while also reducing burdens on research site staff?
Targeting Complement to Reduce Disease Activity: Challenges and Opportunities in the Publicly Available Data (Part Two)
In part one of this complement blog series, the complement cascade and its role in various diseases was introduced, as well as the potential for mechanistic modeling to support development of complement‑targeted therapeutics. COMPLEMENTsym, a quantitative systems pharmacology (QSP) model of complement focused on the alternative and terminal pathways (AP, TP, respectively) was introduced.
Don’t Wait Until Phase III: Why Early DILI Prediction is Key to Drug Development Success
As anyone who has worked in the pharmaceutical industry for awhile can tell you, there are many challenges, but one in particular keeps many of us up at night – the specter of drug-induced liver injury (DILI) lurking later in the drug development process.
Key Takeaways on the Acceptability of PBPK from the ICH Harmonised Guideline on Drug Interaction Studies
One of the significant challenges faced by pharmaceutical companies is the sometimes unclear guidance on what data regulators want to see included in their submissions and the format in which it should be provided.
The Power of Using a Single PBPK Modeling and Simulation Platform
Physiologically-based pharmacokinetic (PBPK) modeling is now a standard tool used across the pharmaceutical industry to increase understanding of a drug’s behavior in the body and to help guide its development.
Women in Science: Dr. Mitali Gaurav, Assistant Director, Pharmacometrics
The first algorithm ever developed for processing by machine was designed by Ada Lovelace, a pioneering mathematician in the 19th century.
Building Patient Trust with Next-Generation Clinical Trial Training
Patient trust is critical to ensuring adequate enrollment and retention of clinical trial participants.
Women in Science: Nancy Lin, Pharmacometrician I
In a world where only 30% of researchers are female, it’s critical to highlight the women who have built their careers in STEM and share their insights and advice with others.
April 2024 News/Events
How to Use Your Predictions to Support Regulatory Submission
Women in Science: Camila de Almeida, Director of Clinical Pharmacology
Dr. Camila de Almeida, Director of Clinical Pharmacology at Simulations Plus, shares her proudest accomplishments, career trajectory, and words of advice for future women in science.
Targeting Complement to Reduce Disease Activity: Quantitative Systems Pharmacology (QSP) to Enhance Efficient Drug Development: Part One
Deficiency or dysfunction in regulatory factors that control the complement cascade critically contribute to several rare diseases...