The Certara Blog

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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Using Virtual Cancer Patients to Probe the Mechanisms of Oncology Drug Disposition

Using Virtual Cancer Patients to Probe the Mechanisms of Oncology Drug Disposition

Oncology drug developers face a distinct set of challenges. Oncology drugs are often very toxic which precludes conducting clinical trials in healthy volunteers. In addition, cancer patients differ from healthy people in terms of their demographics and physiology. These changes mean that the pharmacokinetics of drugs may be altered in this population compared to healthy […]

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Using PBPK Models to Assess Fetal Drug Exposure

Using PBPK Models to Assess Fetal Drug Exposure

The tragedy of thalidomide provides a cautionary tale about the potential for birth defects resulting from fetal exposure to drugs. Thalidomide was used to treat morning sickness in pregnant women. By the time it was banned in 1962, more than 10,000 children had been born with thalidomide-induced birth defects. “Phocomelia,” wherein babies were born with […]

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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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Using PBPK Models to Optimize Anti-HIV Drug Dosing in Pregnant Women

Using PBPK Models to Optimize Anti-HIV Drug Dosing in Pregnant Women

Antiretroviral drugs are a critical tool in preventing mother-to-child transmission of HIV. Yet, antiviral treatment options for pregnant women lag behind the “non-pregnant” population. In this blog post, I’ll discuss the reasons for this lag and how physiologically-based pharmacokinetic (PBPK) models can simulate PK during pregnancy and thus help optimize dosing for this special population. […]

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A Targeted Approach to Medicine and Dosing—A Necessity for Sustainable Healthcare

A Targeted Approach to Medicine and Dosing—A Necessity for Sustainable Healthcare

President Obama, during his 2015 State of the Union Address, launched the Precision Medicine Initiative “to enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized care.” The message given to the American people reinforced the critical need to implement precision medicine into […]

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How to Harness Public Clinical Trial Data to Assess Drug Candidates

How to Harness Public Clinical Trial Data to Assess Drug Candidates

Publicly available clinical trial data represent an underutilized source of information. If properly extracted and analyzed, the data provide valuable input for facilitating go/no go decisions, performing comparative effectiveness and portfolio evaluations in support of in/out licensing, and optimizing overall drug development decisions, including dose and dosing regimens. Clinical Outcomes Database Explorer, CODEx, is an […]

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6 Signs You Need Help with Submission Planning

6 Signs You Need Help with Submission Planning

Setting and adhering to a timeline for planning, drafting, reviewing, and editing regulatory documents needed for the submission dossier is a major challenge for drug development teams. I think of this process as having three phases: “discovery, drive, and survive.” In a previous blog post, I discussed the planning that occurs in the discovery phase. […]

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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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Modeling & Simulation Take a Prominent Role in FDA’s Newly Published DDI Guidances

Modeling & Simulation Take a Prominent Role in FDA’s Newly Published DDI Guidances

On October 25, 2017, the FDA published two new guidance documents on drug-drug interactions (DDI). These guidance documents replace the February 2012 guidance, “Drug Interaction Studies—Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations.” According to the FDA, these new guidances reflect the agency’s current thinking and greater learnings on DDI and provides a […]

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PML School Review

Phoenix Modeling Language School: The Semester in Review

Phoenix® WinNonlin® uses Phoenix Modeling Language (PML) to encode pharmacokinetic (PK) and pharmacodynamic (PD) models. Although most models can be built using the Phoenix graphical user interface (GUI), some models require custom coding with PML. During the latter part of 2016, Certara’s support team, led by Dr. Bernd Wendt, Director of Training and Support, introduced […]

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A Chat with Biopharmaceutics Expert, Professor Jennifer Dressman

A Chat with Biopharmaceutics Expert, Professor Jennifer Dressman

Professor Jennifer Dressman is fearless—both in her science and her career. Born and raised in Australia, she holds degrees in pharmacy and a doctorate in pharmaceutics. Having held positions at Burroughs Wellcome and the University of Michigan, College of Pharmacy in the United States, she was offered her dream job as a professor at the […]

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The European Regulatory Landscape for Pediatric Drug Development

The European Regulatory Landscape for Pediatric Drug Development

In my 35 years of working to develop safer, more effective medications for children, I’ve often been asked about how to navigate the regulatory landscape in the US and Europe. In a previous blog post, I discussed the latest FDA trends regarding pediatric drug development. In this blog, I’ll focus on the path for achieving […]

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FDA Reauthorization Act (FDARA) Affirms Commitment to Innovative MIDD Strategies

FDA Reauthorization Act (FDARA) Affirms Commitment to Innovative MIDD Strategies

Quietly, without any political rancor, the FDA Reauthorization Act of 2017 (FDARA) was passed by the US Congress and was signed into law by President Trump in late August. The FDARA reauthorizes the Prescription Drug User Act Fee Amendments (PDUFA) for the fifth time, the Medical Device User Act Fee Amendments (MDUFA) for the third […]

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7 Savvy Ways to Reduce Quantitative Systems Pharmacology Models

7 Savvy Ways to Reduce Quantitative Systems Pharmacology Models

Modeling and simulation has become an indispensable part of drug development. Historically, the type of modeling employed changes as a drug moves through the stages of drug development—from discovery to pre-clinical testing to clinical trials. At the early stages of drug discovery, we may use systems biology models to identify drug targets and possible compounds, […]

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What the FDA Expects from Your Pediatric Drug Program

What the FDA Expects from Your Pediatric Drug Program

Historically, 80 percent of medicines used in children had little to no data guiding prescribers on proper use. To address this market failure, regulatory legislation for drug development in pediatric patients was passed worldwide over the past decade. The number of drugs tested in and labeled for children has increased dramatically as a result. In […]

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