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Pharmacometrics Skills Competition MIDD Gran Prix
Sitting around the Certara’s Raleigh office conference room, sketching out a pitch for a pharmacometrics contest at a national meeting, none of us were overly confident in its viability. Mark Lovern...
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Spotlight on the PAGE Student Sponsorship Winners
When I attend scientific conferences, I feel as though I have reached my own personal “Nerdvana.” I love everything about them! I love going to the sessions and learning the latest cutting edge...
View ArticleAccomplish More with Phoenix
Phoenix 8.1, the newest version of Certara’s innovative PK/PD modeling and simulation software used globally by researchers and drug developers in pharma, academia, and regulatory agencies, will be...
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Overcoming Pitfalls and Challenges with Software Validation
As a quality consultant and quality system subject matter expert in the Life Sciences Industry for over 25 years, I have worked for many pharmaceutical companies both large and small and as a...
View ArticleValidate Your Expertise in PK/PD NCA Analysis Through Certara Professional...
In the ongoing commitment to education and coinciding with the launch of Phoenix 8.1, Certara has introduced a new certification program available through Certara University. The new online...
View ArticleClinical Pharmacology Gap Analysis: Lessons Learned
Clinical pharmacology gap analysis is a tool for outlining your drug program’s needs, prioritizing these needs, and providing a framework for how to satisfy them. This tool can create value for drug...
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Level C IVIVC: What Is It, and When Do You Use It?
In vitro in vivo correlation (IVIVC) links in vitro drug data to in vivo performance. Regarding in vivo performance, IVIVC can predict either the in vivo plasma time-concentration curve or in vivo...
View ArticleMaking Sense of 6MWT Variability: Developing a Disease Progression Model for DMD
Duchenne Muscular Dystrophy (DMD) is a life-threatening, sex-linked, pediatric rare disease, primarily affecting boys. It is characterized by progressive muscle degeneration, weakness, and eventually...
View ArticleUsing 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...
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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...
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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...
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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...
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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...
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