The Certara Blog: Clinical Pharmacology Strategy

Real World Evidence Marches Forward in Drug Development

The end of 2018 ushered in a flurry of new regulatory guidance and sponsor enthusiasm on real-world evidence (RWE) and its adoption in the drug development process. While the collection of real-world data (RWD) and use of RWE is not new, they are now poised to have a profound impact on our industry.  Today, it […]

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Benefits of Apocalyptic Clinical Pharmacology During Regulatory Review

When developing a drug, pharmaceutical companies need to answer many questions to successfully undergo regulatory review and bring the drug to market. Apocalyptic clinical pharmacology is a framework that drug developers can use to uncover essential relationships between the drug dose and response or outcome. In other recent blog posts, I have covered what the […]

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Using Simcyp-guided ADME Biomarker Discovery to Prospectively Identify Patients at High Risk of Drug Toxicity

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 anti-cancer medications that are taken orally, such as the protein kinase inhibitors (KIs), are ideal candidates for model-informed precision dosing (MIPD) technologies.1 One of these technologies is called physiologically-based […]

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Lessons Learned - Case Studies of Apocalyptic Clinical Pharmacology

Lessons Learned: Case Studies of Apocalyptic Clinical Pharmacology

Apocalyptic clinical pharmacology helps drug developers save resources and time through providing a framework for understanding the interaction of the drug under development with the biological system. This framework also helps answer questions from regulatory authorities who are evaluating the safety and efficacy of the drug. Making informed decisions throughout the drug development process requires […]

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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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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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Clinical Pharmacology Gap Analysis - Your FAQs

Clinical Pharmacology Gap Analysis: Your FAQs

As drug development has become more complex, with a higher risk of failure, greater uncertainty, and increased expense, the need for a quantitative and regulatory science-based strategy becomes clear. The first step in that performing that strategic assessment is a gap analysis and roadmap. Over the last couple of months, I’ve written a series of blog […]

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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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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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Using a Pharmacology to Payer Framework to Support Product Development

Using a Pharmacology to Payer Framework to Support Product Development

Modeling and simulation (M&S) of complex systems has primarily advanced vertically in differing scientific domains with a variety of domain-specific approaches and applications. The pharmacology to payer (P2P) concept is a way to connect independent domains to address drug development market failures. As an initial proof of concept, we collaborated with a team of clinical pharmacologists, […]

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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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How to Plan and Implement a Pharmacology to Payer Framework

How to Plan and Implement a Pharmacology to Payer Framework

Pharmacology to the payer (P2P) is an innovative approach to create a framework for dialogue between drug sponsors, regulators, and payers. The core structure is the sequential linking of quantitative mathematical models—pharmacology, pharmacokinetics/pharmacodynamics (PK/PD), disease progression, epidemiology, health utilization, and health economics. In this blog post, we discuss how working with an amazing team of […]

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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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