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CDISC、SDTM、およびADaMについてわかりやすく解説

The world of clinical study data can be challenging and confusing. For those in the pharmaceutical industry, understanding and managing CDISC standards is essential to collecting quality and compliant clinical study data. Below, we take a look at three of CDISC’s essential standards, CDASH, SDTM and ADaM. We break down the basics of these models, … Continued

9 Frequently Misunderstood Concepts in PK/PD Modeling

In teaching pharmacometrics, I’ve noticed that scientists have difficulty with certain PK/PD modeling concepts. Maybe you’ve read about some of these terms in journal articles, but didn’t know what they meant? Or you’ve heard these terms bandied about by colleagues, but felt too shy to ask them what they meant? I’ll clarify some important concepts … Continued

9 Things Your Boss Wishes You Knew About PK/PD Modeling

Over the course of my career, I have taught the theory and practical applications of PK/PD modeling to hundreds of scientists. In this blog post, I’ll share some of my most popular tips for solving common difficulties encountered by pharmacometricians. The tools of the trade While I have worked with a number of pharmacometrics tools, I … Continued

Derivation for Logarithmic Trapezoidal AUC Calculation

Calculating area under the curve requires the use of two separate equations: one is follows the “linear trapezoidal rule” and the other follows the “logarithmic trapezoidal rule.”These equations are normally presented in textbooks without derivations so all you have to do is insert the concentrations and times and you can calculate the area under … Continued

Calculating the Elimination Rate Constant

The elimination rate constant is the rate at which drug is cleared from the body assuming first-order elimination. Various abbreviations are used to represent the elimination rate constant including ke, kel, λ, and λz. The calculation of the elimination rate constant can be done using pharmacokinetic parameters or it can be done directly from a … Continued

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

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 … Continued

Bioanalytical Calibration Curves

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 … Continued

Radiometric Analysis

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 … Continued

Understanding LC/MS/MS

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 … Continued

What is HPLC/UV?

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, … Continued

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