The Certara Blog: PK/PD Modeling & Simulation

Using Virtual Twin Technology to Predict Drug Exposure in Individual Patients

Using 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 interactions (DDIs), to inform dosing and clinical study design, to predict drug exposure, to predict variation in drug clearance, and to understand mechanisms of drug disposition. Virtual Twin technology, based on […]

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Introduction to Apocalyptic Clinical Pharmacology in Drug Development

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 pharmacology in drug development provides value offering a framework for thinking about the relationship between the drug dose and the biological system. What is apocalyptic clinical pharmacology? […]

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Answers to Your Burning Questions on Level C IVIVC

Answers 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 at one of three levels—A, B, and C. Getting the most out of this tool requires knowing when and how to use which level of IVIVC. Here are some […]

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Using Virtual Twin Technology for Model-informed Precision Dosing

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 and simulation (M&S) approach in healthcare that is used to predict the most effective and/or least toxic drug dose for a patient. MIPD could revolutionize healthcare […]

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Making Sense of 6MWT Variability - Developing a Disease Progression Model for DMD

Making 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 functional loss. DMD is caused by a mutation in the dystrophin gene, a protein needed to maintain muscle integrity, and for improving signaling and growth in differentiation of the muscle tissue. […]

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Level C IVIVC - What Is It, and When Do You Use It?

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 pharmacokinetic (PK) parameters like Cmax and AUC. In this blog, I will discuss Level C IVIVC, and when you should use this approach. […]

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Clinical Pharmacology Gap Analysis - Lessons Learned

Clinical 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 development programs. While gap analysis can be performed at any point in the drug development continuum, early engagement is best for maximizing its benefits. […]

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Validate Your Expertise in PK/PD NCA Analysis Through Certara Professional Certification

Validate Your Expertise in PK/PD NCA Analysis Through Certara Professional Certification

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 accreditation program validates the scientists’ PK/PD data analysis skills using Certara software such as Phoenix WinNonlin and expands their professional reach. I caught up with Ana Henry, […]

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Overcoming Pitfalls and Challenges with Software Validation

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 consultant with many clients in the pharmaceutical, biotech, and medical device industries. These clients possess a range of experience in software validation—from […]

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Accomplish More with Phoenix

Accomplish 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 available on June 15, 2018. Major enhancements were introduced in the Phoenix workbench last year. And as an ongoing commitment to support compliance and efficiency, many features […]

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Spotlight on the PAGE Student Sponsorship Winners

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 insights from the leaders in our field. I love walking the aisles of posters and getting to talk one-on-one with scientists about […]

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Pharmacometrics Skills Competition MIDD Gran Prix

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 had been talking about the importance of communication skills for pharmacometricians. For them to influence critical drug development decisions, they should be able to […]

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Using M&S to Evaluate Oncology Drug Dosing

Using M&S to Evaluate Oncology Drug Dosing

There are numerous challenges in developing oncology drugs: (1) they are often very toxic which precludes conducting clinical trials in healthy volunteers, (2) the PK of a drug may be altered in cancer patients due to demographic and physiological differences as compared to healthy volunteers, and (3) cancer patients face elevated drug-drug interaction (DDI) risk […]

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How to Maximize the Benefits of Clinical Pharmacology Gap Analysis

How to Maximize the Benefits of Clinical Pharmacology Gap Analysis

Many companies have tried and true clinical pharmacology practices. But when the rubber hits the road for your drug program, will these practices support regulatory success? Has your historic approach to drug development been updated to include the latest modeling and simulation innovations? It’s hard to change how you’ve historically done things. But, do you […]

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Ready, Set, Model! Take PK/PD Analysis to New Heights with Phoenix 8.0

Ready, Set, Model! Take PK/PD Analysis to New Heights with Phoenix 8.0

Dr. Scott Gottlieb, the Commissioner of Food and Drugs, has outlined the steps the US FDA will take to implement the 21st Century Cures Act. In outlining the plan, the Commissioner endorses modeling and simulation approaches to increase the efficiency of drug development. Certara has launched Phoenix® 8.0, the latest version of the innovative PK/PD […]

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How Clinical Pharmacology Gap Analysis Can Create Value

How Clinical Pharmacology Gap Analysis Can Create Value

During my years reviewing applications for the US FDA, I encountered a lot of poor planning concerning a drug’s clinical pharmacology program. This poor planning left the company either lacking data to make informed decisions or scrambling at the end of development to address unanswered issues. Early planning is key to regulatory success, not only […]

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The Biggest Drug Development News Stories in 2017

The Biggest Drug Development News Stories in 2017

When I reflect on the state of drug development in 2017, the opening lines of Charles Dickens’ A Tale of Two Cities comes to mind. It was the best of times, it was the worst of times, it was the age of wisdom, it was the age of foolishness, it was the epoch of belief, […]

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A Practical Approach to the Challenges of Pediatric Drug Development

A Practical Approach to the Challenges of Pediatric Drug Development

Drug developers can’t take an adult clinical trial protocol and simply retool it for pediatrics. Yet, in my work at a pediatric clinical research organization (CRO), I frequently see sponsors attempt to do just that. Successfully implementing a pediatric drug development plan poses challenges regarding trial planning, design, and conduct. In this blog post, I’ll […]

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