PK/PD Modeling & Simulation

The Highlights in Model-based Drug Development for 2014

Suzanne Minton

As the end of the year draws near, I want to thank all of our customers for letting us be your biosimulation and model based drug development solution provider. We feel honored to be able to play a small, but crucial role in your success in bringing safe and effective drugs to patients. 2014 has […]

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Topics: PK/PD Modeling & Simulation, Scientific Informatics

A Change of Heart at the Cardiac Safety Research Consortium

Christine Garnett

The ICH E14 guidance recommends that all new drugs with systemic bioavailability are assessed for the ability to delay cardiac repolarization as measured by the QT/QTc interval on the surface ECG. For most drugs, this evaluation is performed in the Thorough QT/QTc (TQT) study. Could using model-based approaches during routine early studies influence the current […]

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Topics: PK/PD Modeling & Simulation

5 Updates to the Simcyp Simulator You’ll Be Psyched About

Iain Gardner

The Simcyp™ Population-based Simulator streamlines drug development through the modelling and simulation of physiologically-based pharmacokinetics (PK) and pharmacodynamics (PD) in virtual patient populations. It incorporates numerous databases containing human physiological, genetic and epidemiological information. By integrating this information with in vitro or clinical data, the Simulator can predict PK/PD behavior in ‘real-world’ populations. It can be used to select […]

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Topics: PBPK Modeling & Simulation

Population Modeling Helps Predict the Impact of E-cigarettes on Health

Bill Poland

The Oxford Dictionaries 2014 Word of the Year is “vape” – to inhale and exhale the vapor produced by an electronic cigarette (also known as e-cigarette or e-cig) or similar device. This choice reflects the meteoric rise in e-cig popularity. E-cigs, which deliver nicotine without carcinogenic tar, hold the promise to save the lives of […]

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Topics: Uncategorized

How to Manage Pre-clinical Data as a Strategic Asset

Stuart Horowitz

A recent report by Deloitte identified the #1 trend in the life sciences market as an increased focus on patient safety and enforcement. While it seems obvious to consider safety issues in approved drugs, regulatory agencies such as the FDA and EMA (European Medicines Agency) are extending their scrutiny to the entire drug development process, […]

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Topics: Scientific Informatics

The Challenges of Determining Drug Dosing for Rare Diseases

Suzanne Minton

Most people are familiar with the leading causes of morbidity and mortality in the United States—heart disease, cancer, and diabetes. However, did you know that an estimated 350 million people worldwide suffer from rare diseases? In this blog post, I’ll be discussing what constitutes a rare disease, how developing orphan drugs to treat rare diseases […]

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Topics: PK/PD Modeling & Simulation

PBPK Modeling and Simulation Discussed at the AAPS Annual Meeting

Ellen Leinfuss

I recently got the chance to attend the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition in San Diego, California. It was a valuable opportunity to see some truly innovative scientific approaches to the toughest challenges in drug development. Pediatric drug development, in particular, remains a top challenge for the pharmaceutical industry as […]

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Topics: PBPK Modeling & Simulation

Why Phoenix NLME is the Best in Class Solution for Pop PK/PD

Ana Henry

Over the past 20 years, I have seen a number of significant changes in the pharmaceutical industry’s approach to the study of pharmacokinetics and pharmacodynamics (PK/PD). With the high risk and large expense associated with drug development, it is imperative to have the best PK/PD analytical tools to aid in understanding the safety/efficacy profile of […]

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Topics: PK/PD Modeling & Simulation

Reasons to Attend Certara’s CADD, PK/PD, and PBPK Modeling Courses

Suzanne Minton

As the manager of scientific communication for Certara, part of my job is to educate new and existing clients on the ways they can maximize their utilization of Certara’s software and consulting services. Therefore, it was important for me, early on, to experience our training solutions to better understand our clients’ perspectives. At Certara, we […]

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Topics: PBPK Modeling & Simulation, PK/PD Modeling & Simulation

Solving Molecular Discovery Problems with CoMFA over the Years

Richard Cramer

Nearly half of drug candidates fail because of inadequate safety in pre-clinical testing, representing an expensive loss of investment and lost opportunity. Often, drugs are found to cause toxicity through off-target activity. Therefore, understanding how drugs interact with their target receptors, and minimizing off-target activity is crucial to developing effective medications. Over my career, I’ve […]

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Topics: Uncategorized

Commonly Held Myths About the FDA’s CDISC Mandate

Peter Schaefer

Have you heard the FDA will require electronic submissions that use CDISC standardized study data? In my work at Certara, I’ve noticed there’s a lot of confusion, and even significant apprehension, surrounding this issue. To combat the misconceptions about what these regulations will mean for drug developers, I’ve compiled a list of common questions (and […]

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Topics: PK/PD Modeling & Simulation

Synthetic Chemistry + CADD = Muse Invent

Brian Masek

Welcome! We’re excited to launch Certara’s blog. This gives us a chance to comment on important news and topics in the rapidly changing world of drug development. Our blog will offer more than one contributor to ensure you get multiple perspectives on the issues impacting us all. We hope that you’ll share your comments about our solutions […]

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Topics: Uncategorized

How PBPK Modeling Will Make Drugs Safer, Cheaper, and More Effective

Daniel Weiner

Historically, drugs have been selected using various methods (eg, biological and chemical screens). Candidate drugs were often pushed into the clinic with only a rudimentary understanding of the link between drug exposure and resultant effect(s). As a consequence, drug development has been inefficient by relying on trial and error at the clinical stage, not to […]

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Topics: PBPK Modeling & Simulation

Adding a Placebo Component to Your PK/PD Model in Phoenix

Nathan Teuscher

PK/PD modeling is an exciting are of research in clinical pharmacology. Most often we try to model the effect of a drug by drawing relationships between the concentration and effect. This usually entails subsetting the data to exclude information from subject that received placebo during the trial. But statistical comparisons in clinical studies are most […]

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Topics: PK/PD Modeling & Simulation

Bioanalytical Calibration Curves

Nathan Teuscher

At the request of a reader, I have decided to extend my series on bioanalysis to include another topic: calibration curves. The calibration curve is they keystone of bioanalysis. It is what links the instrument response to a specific concentration of drug. It is like the magic decoder ring that helps you decipher the hidden […]

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Topics: PK/PD Modeling & Simulation

Bioanalytical Method Validation

Nathan Teuscher

In this final post regarding bioanalysis, I will review a few of the main ideas related to bioanalytical method validation. The purpose of a method validation is to demonstrate that a specific bioanalytical method can reliably determine the concentration of drug in a study sample with a high degree of confidence. Validation does not mean […]

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Topics: PK/PD Modeling & Simulation

Radiometric Analysis

Nathan Teuscher

One of the oldest methods used for the quantitation of drug molecules is radiometric analysis. This generally involves quantitation of radiation from beta-emitting radioactive isotopes such as 14C, 3H or 32P. Radiometric analysis is one of the most precise, sensitive, and efficient detection methods; however, there are many technical and social challenges with using this […]

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Topics: PK/PD Modeling & Simulation

Ligand Binding Assays

Nathan Teuscher

Our discussions of various bioanalytical methodologies over the past few weeks has focused on chromatography and small molecule analysis. Today we are going to discuss a collection of methods that is commonly used for large molecules, such as peptides, peptides and macro-molecules. These molecules are often called “biologics” because they are generally derived from endogenous […]

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Topics: PK/PD Modeling & Simulation

Understanding LC/MS/MS

Nathan Teuscher

The most common bioanalytical method in use today is LC/MS/MS, or liquid chromatography (LC) tandem mass spectrometry (MS). This is a very versatile, robust, and sensitive methodology that is used for nearly all small molecules. In addition, this technology is amenable to automation and unattended analysis. The LC/MS/MS methodology is very similar to HPLC/UV, which […]

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Topics: PK/PD Modeling & Simulation

What is HPLC/UV?

Nathan Teuscher

In my series about bioanalysis for the pharmacokineticist, I thought I would start with the bioanalysis methodology that was in use when I began my career in pharmaceutical development: HPLC/UV. The first part of this method (HPLC) is the separation technology. The second part (UV) is the detection technology. In the remainder of this post, […]

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Topics: PK/PD Modeling & Simulation
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