Using Virtual Twin™ Technology for Model-informed Precision Dosing
In a recent Expert Review of Clinical Pharmacology article, I assessed the status and future direction of precision dosing in clinical medicine.1 Model-informed precision dosing (MIPD) is a modeling...
View ArticleAnswers to Your Burning Questions on Level C IVIVC
In vitro-in vivo correlation (IVIVC) technology allows formulation and manufacturing (CMC) professionals to understand how dissolution parameters affect in vivo drug performance. IVIVC can be performed...
View ArticleClik here to view.
Introduction to Apocalyptic Clinical Pharmacology in Drug Development
In this blog, I will introduce “apocalyptic clinical pharmacology” and provide a framework for using this approach in drug development, which can save resources and time. Apocalyptic clinical...
View ArticleUsing Virtual Twin™ Technology to Predict Drug Exposure in Individual Patients
Physiologically-based pharmacokinetics (PBPK) is a valuable resource to support decisions throughout drug development for sponsors and regulators. PBPK is used extensively to predict drug-drug...
View ArticleTrial Simulation: An Innovative Approach to Assess Pediatric Drug Dosing
As a pediatric nephrologist, I help care for some very sick kids. And because our young patients are so ill, it’s a challenge to recruit them into clinical studies. Of course, we want to provide our...
View ArticleUsing Simcyp-guided ADME Biomarker Discovery to Prospectively Identify...
As novel molecular targets are being continuously discovered and new treatments developed, oncology is one of the biggest therapeutic areas in precision medicine. In particular, new targeted...
View ArticleClik here to view.
A Beginner’s Guide to Performing Clinical Trial Simulation
The astronomical cost of conducting clinical drug trials means that a suboptimal trial design adds significant risk to a drug program. Clinical trial simulation allows drug developers to test different...
View ArticleManaging Immunogenicity Using Quantitative Systems Pharmacology
The Challenge of Immunogenicity in Biologics Drug Development Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Biologically-based therapeutic drugs comprise...
View ArticleClik here to view.
Simulating Viral Dynamics in the New Trial Simulator
Antiviral drug development presents a unique set of challenges. First, viruses are constantly mutating, and drug-resistant viruses emerge easily. Therefore, combination therapies are typically required...
View ArticleThe Role of Quantitative Systems Pharmacology in First-in-Human Trial Design
Quantitative Systems Pharmacology (QSP) is a relatively new discipline with enormous potential to improve pharma R&D productivity and inform decision-making across the drug development process from...
View ArticleClik here to view.
Spotlight on the PAGE Student Sponsorship Winners 2019
One of my favorite things about being a scientist is how research brings people together. No matter your background, scientists all share a passion for expanding the frontiers of knowledge to improve...
View ArticleCertara Scientists Support TB Alliance’s Groundbreaking New Drug
On August 14, the FDA approved the anti-TB drug pretomanid, only the third new drug for tuberculous (TB) in almost 50 years. Pretomanid’s developer, TB Alliance has become the first not-for-profit...
View ArticleClik here to view.
Chatting with Mayumi Hasegawa: Global Drug Development Expert
“Wherever the art of Medicine is loved, there is also a love of Humanity.” – Hippocrates I cannot think of this quote from Hippocrates, the father of medicine, without also thinking of my Certara...
View ArticleHow PK CDISC Data Tech Solutions Can Accelerate Your Drug Development
If you work in pharma, you may have heard the following acronyms: CDISC, SDTM, ADaM. They sound much like alphabet soup. But, in reality, they relate to data standards for drug development. So, what...
View ArticleClik here to view.
Applying decision analysis to drug development for COVID-19 & future pandemics
It is gratifying to see the continued uptake and adoption of tools for model-informed drug discovery and development since the early 2000s.1 Great advances have been made in modeling tools supporting...
View ArticleClik here to view.
The Value of Modeling and Simulation in Vaccine Development
In an earlier blog, I outlined a project to develop a Modeling & Simulation (M&S) timing model – as an alternate approach to dedicated clinical studies – to determine the best time to vaccinate...
View ArticleThe Defining Role of Clinical Pharmacology for COVID-19 Drug Development
On March 11, 2020, the World Health Organization (WHO) characterized the COVID-19 outbreak as a pandemic. With no direct pre-existing immunity, the virus has spread rapidly on a global scale. At the...
View ArticleLocal Therapies for the Global COVID-19 Pandemic
Drug repurposing is a priority The rapid spread of COVID-19 has triggered a global effort for accelerating the development of diagnostics, vaccines, and therapeutics. The threat of a possible recurring...
View Article10 Things You Should Consider When Planning a COVID-19 Clinical Drug Trial
Pandemics by nature are excellent fodders for disruptive innovation. They force you to think out of the box. The whole health care apparatus is on the COVID-19 frontlines with some more directly...
View ArticleClik here to view.
Modeling and Simulation: Optimizing Phase 3 Study Design to obtain FDA Approval
Modeling and simulation (M&S) is transforming how drugs are developed, and how they undergo regulatory review. Software, such as Phoenix NLME and Trial Simulator, provides the ability to use...
View Article
