Model-based Meta-analysis

That’s So Meta: How Model-based Meta-analysis Informs Drug Development

Mark Lovern

Making the right choices in drug development often means the difference between getting a new medication to patients and it ending up in the scrap heap of failed programs. There is a surfeit of publically available information on approved drugs as well as those currently in development. How can sponsors turn clinical trial data into […]

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Topics: Model-based Meta-analysis

100 Articles That Will Help You Understand PBPK Modeling & Simulation

Suzanne Minton

As a company with a strong academic foundation, our scientists actively publish the results of their research in the form of conference abstracts and peer-reviewed papers. We’re proud to announce that our PBPK modeling and simulation group has hit a milestone of having published more than 100 papers since 2007. In this blog post, I’ll discuss […]

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Topics: PBPK Modeling & Simulation

How to Revamp Your Approach to Conventional IVIVC Models

Nikunjkumar Patel

An IVIVC (in vitro-in vivo correlation) is a predictive mathematical model describing the relationship between the in vitro properties of a dosage form and the in vivo responses. Drug developers frequently find IVIVCs useful for a number of reasons: They can use dissolution tests as a surrogate for human bioequivalence (BE) studies. They can support […]

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Topics: PBPK Modeling & Simulation

What NASA’s New Horizons has in Common with Regulatory Writing

Michael Blaze

Today, NASA’s New Horizons spacecraft will pass by Pluto in the outer solar system after a journey of more than 7.8 million miles (12.5 million kilometers). That is, if everything goes well. After a 6-year journey and a cost of $728 million dollars, mission managers are hoping to avoid a mission ending error caused by […]

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Topics: Regulatory & Medical Writing

Pediatric Clinical Trials and Tribulations

Ellen Leinfuss

Last month, Certara sponsored the 11th Pediatric Clinical Trials conference in Philadelphia. First, I have to say that the content of this conference was among the best I have ever heard. Each speaker added to the dialogue, and the group was able to share and collaborate on how to make meaningful improvements to the field […]

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Topics: Regulatory & Medical Writing

What You Need to Know about the Precision Medicine Initiative

Suzanne Minton

Last month, I was fortunate to be able to represent Certara at the BIO International Conference in Philadelphia, PA. One of the most exciting sessions that I attended was the Personalized Medicine Plenary with Dr. Francis Collins, the director of the NIH. He discussed how the Precision Medicine Initiative (PMI) will revolutionize the approach to […]

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Topics: Clinical Transparency & Disclosure

Think Global, Act Local: Supporting Orphan Drug Development in NJ

Dana Cohen

You could say that I’m a Jersey Girl. Having lived all my life in the Garden State, it’s important to me to help give back to the New Jersey community that is home to our Princeton headquarters. So, I’m really proud that Certara has supported the approval of several orphan drugs for rare diseases, one […]

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Topics: PK/PD Modeling & Simulation

Motesanib’s Promise & Peril: Population PK Modeling an Anticancer Drug

Nathalie Gosselin

When thinking about the challenges of oncology drug development, I recall the advice of the 6th century BCE military strategist, Sun Tzu: If you know the enemy and know yourself, you need not fear the result of a hundred battles. If you know yourself, but not the enemy, for every victory gained you will also […]

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Topics: PK/PD Modeling & Simulation

Gaining FDA Support for a Prognostic Biomarker, Giving Patients Hope

Samer Mouksassi

As a clinician scientist, I get really excited about helping sponsors develop new treatments for patients. For some diseases, the lack of a validated prognostic biomarker is an impediment to developing effective treatments. In this blog post, I’ll discuss how we worked with the Critical Path Institute (C-Path) Polycystic Kidney Disease Outcomes Consortium to gain […]

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Topics: Uncategorized

How to Explain the Value of Modeling and Simulation to Your Grandma

Suzanne Minton

As most scientists can attest, it’s not always easy to communicate the importance of your work to non-scientists. I personally experienced this when my fiercely intelligent grandmother, a former elementary school teacher, asked to read a copy of my dissertation. When I asked her what she thought of it, I realized that her understanding of […]

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Topics: Clinical Transparency & Disclosure

Why Using In Silico Modeling for Cardiac Safety is the Next Big Thing

Sebastian Polak

The sky high cost of drug development means that late stage drug attrition is especially devastating. Thus, the ability to assess potential drug safety issues early— using in vitro data— would be very beneficial. The current paradigm for cardiac safety pharmacology is rooted in the preclinical ICH S7B and clinical ICH E14 guidelines. There have […]

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Topics: PBPK Modeling & Simulation

Dosing for Two: How Pharmacometrics Supports Drug Safety in Pregnancy

Alice Ke

According to the US Census Bureau, there is a birth every eight seconds in the United States. Women frequently take prescription and over-the-counter drugs during pregnancy. Given the ubiquity of pregnancy and births, you’d think that there would be a robust understanding of the safety and efficacy of drugs in pregnant women. However, the vast […]

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Topics: PBPK Modeling & Simulation

A Clearer Crystal Ball: A Meta-regression Model Predicts TB Relapse

David Hermann

What would you guess is the world’s most neglected disease? I bet that you wouldn’t pick tuberculosis (TB)— a disease that causes an estimated 9 million new cases and 1.3 million deaths annually. This infectious disease is caused by the bacterium Mycobacterium tuberculosis. TB usually attacks the lungs, but can attack any part of the body. […]

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Topics: Uncategorized

1 Size Doesn’t Fit All: PBPK M&S for Individual Risk of Complex DDIs

Helen Humphries

Drug-drug interactions (DDIs) are a primary threat to the safety and efficacy of clinical practice. Clinically relevant drug interactions are primarily due to drug-induced alterations in the activity and quantity of metabolic enzymes and transporters. Indeed, DDIs that cause unmanageable, severe adverse effects have led to restrictions in clinical use and even, drug withdrawals from […]

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Topics: PBPK Modeling & Simulation

Do the Right Thing: Ethical Mandates for Clinical Trial Transparency

Kelley Kendle

The history of biomedical research in the United States has long been plagued with ethical problems. Writer Rebecca Skloot details a famous example of this history in her book, “The Immortal Life of Henrietta Lacks.” The non-fiction work recounts the origin of the HeLa cells—derived from the tumor of a Baltimore woman named Henrietta Lacks. […]

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Topics: Clinical Transparency & Disclosure, Regulatory & Medical Writing

Pediatric Drug Dosing: Tackling Big Problems for Little Patients

Nastya Kassir

The challenges and complexities of pediatric drug development are well recognized. Pharmacometric modeling and simulation (M&S) leverages prior knowledge to support pediatric drug dosing, trial design and regulatory writing for submissions. As the benefits of pharmacometrics for drug development and regulatory decision-making become increasingly well documented, the FDA has challenged the industry to more rigorously apply […]

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Topics: PK/PD Modeling & Simulation

Banish hERGphobia: Using Systems Pharmacology to Assess Cardiac Safety

Masoud Jamei

Is the era of “hERGphobia” finally coming to an end? Drug-induced cardiovascular adverse events are one of the leading causes of drug withdrawals from the market and of drug label restrictions. As a result, biopharmaceutical companies are keen to identify new drug candidates with a propensity to cause arrhythmias, or the heart to beat with […]

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Topics: PBPK Modeling & Simulation

Improve Your Success Rate in Costly Bioequivalence Studies with IVIVC

Ana Henry

Did you know that 84% of the 4 billion prescriptions written each year are for generic drugs? Clearly, generics are a big business. Regulatory agencies, such as the FDA, require generic drug manufacturers to show that generic drugs are bioequivalent to the reference drug. Bioequivalence (BE) studies can also be required for pharmaceutical variations made […]

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Topics: PK/PD Modeling & Simulation

Personalized Toxicology: A New Paradigm for Chemical Risk Assessment

Masoud Jamei

Historically, toxicity testing has been conducted by giving lab animals high doses of chemicals and observing them for adverse events. But quantifying the risks chemicals pose to humans based on animal studies is problematic as the chemical doses are often orders of magnitude higher than environmental levels. Moreover, this process is slow, expensive, and ethically […]

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Topics: PBPK Modeling & Simulation

5 Certara Posters You Should Have Seen at ASCPT 2015

Amin Rostami

I attended and contributed to the recent annual meeting of the American Society for Clinical Pharmacology and Therapeutics (ASCPT) in New Orleans. This is a meeting that I have attended regularly in the past. It was a valuable opportunity to see some truly innovative scientific approaches to the toughest challenges in drug development. If I […]

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Topics: PBPK Modeling & Simulation
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