Educating the World in Biosimulation: Creating Certara University

Frank Garafalo

“Fundamentally Certara is a collection of academic discoveries and scientific minds who are charged with transforming patient care and improving the most crucial research and development and regulatory decisions.  Our training organization and methodology must be equally accountable for this mission.” – Edmundo Muniz I heard these inspiring words from our CEO during my first […]

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Topics: Model-based Drug Development, PK/PD Modeling and Simulation, Training

Tips for custom IVIVC models in Phoenix

Simon Davis

The IVIVC tool within Phoenix is a convenient and powerful tool to build an in vivo-in vitro correlation model using dissolution experiments and real in vivo profiles.  This module can support your organization in formulation development and even in applying for biowaivers. The tool has a flexible library of built-in models that can be modified […]

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Topics: Model-based Drug Development, PK/PD Modeling and Simulation, Training

Meet FDA Bioequivalence Criteria with WinNonlin RSABE Templates

Ana Henry

A study by the FDA Office of Generic Drugs (OGD) reviewed over 1000 bioequivalence (BE) studies of 180 drugs, of which over 30% were highly variable (HV). Because of this high variability, studies designed to show whether generic HV drugs are bioequivalent to their corresponding HV reference drugs may need to enroll large numbers of […]

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Topics: Drug Safety, Model-based Drug Development, PK/PD Modeling and Simulation, Training

Supporting Pharmacometrics Education at the University of Maryland

Ellen Leinfuss

Nelson Mandela is quoted with saying, “Education is the most powerful weapon which you can use to change the world.” At Certara, we are helping change the world by aiding the development of novel medications through our technology-enabled solutions. Indeed, supporting the education of the next generation of pharmacometricians is essential to our mission. In […]

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Topics: Model-based Drug Development, PK/PD Modeling and Simulation, Training

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: Model-based Drug Development, PBPK Modeling and Simulation, PK/PD Modeling and Simulation, Training

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: Training

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 and Simulation, Training

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 and Simulation, Training

What is GLP (Good Laboratory Practice)?

Nathan Teuscher

Good laboratory practice or GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies. The term GLP is most commonly associated with the pharmaceutical industry and the required non-clinical animal testing that must […]

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Topics: Drug Safety, Training

Understanding accelerator mass spectrometry

Nathan Teuscher

Accelerator mass spectrometry (AMS) is an analytical method used to detect the amount of radioactive carbon in a biological sample. It is an extremely sensitive methodology that can be used in early clinical research when conventional radiometric detection methods such as liquid scintillation counting are not possible. AMS is a powerful technique; however, it is […]

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Topics: PK/PD Modeling and Simulation, Training

Where did the 80-125% bioequivalence criteria come from?

Nathan Teuscher

Most people involved in clinical pharmacokinetics are familiar with the 80-125% criterion. This criterion is used to compare two treatments with the purpose of evaluating if the treatments are bioequivalent. But, where did this come from? Why 80-125%? Why not 90-110%? or why not 80-120%? Before we explain where 80-125% came from, let me explain […]

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Topics: PK/PD Modeling and Simulation, Training
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