Simulations Plus

New guidance was recently released by the International Council for Harmonisation (ICH) regarding bioequivalence for immediate release solid oral dosage forms.

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.

Want to see fewer protocol deviations and agile change management in your clinical trials while also reducing burdens on research site staff?

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.

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.

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.

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.

The first algorithm ever developed for processing by machine was designed by Ada Lovelace, a pioneering mathematician in the 19th century.

Patient trust is critical to ensuring adequate enrollment and retention of clinical trial participants.

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.

How to Use Your Predictions to Support Regulatory Submission

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.

Deficiency or dysfunction in regulatory factors that control the complement cascade critically contribute to several rare diseases...

GastroPlus® Monthly Newsletter 2024

As a nutritional biochemist by training, I am really excited about the effectiveness of current treatments for obese patients—and it extends well beyond weight loss. 

Quantitative systems pharmacology (QSP) is gaining acceptance and utilization in many drug development programs, but even those who appreciate its value may not fully recognize the extent to which it has already achieved impact and/or its range of potential applications.

International Perspectives on Model-Informed Precision Dosing

GastroPlus® Monthly Newsletter 2024

According to an article published by United Nations News last year, women in STEM are still not the norm. Only one in three researchers worldwide is female.

GastroPlus® Newsletter February 2024