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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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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Bioanalysis from a PK perspective

Nathan Teuscher

The field of bioanalytical chemistry, or bioanalysis, is an important area of research that has a direct impact on the work of pharmacokineticists. Essentially, bioanalysis converts a blood sample (or any other matrix) into a drug concentration by the use of analytical equipment. Over the next few weeks, I would like to cover a variety […]

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What is WinNonlin?

Nathan Teuscher

A reader suggested that I write a similar post about WinNonlin. Great idea! Thank you! WinNonlin is a pharmacokinetic software package that has grown and evolved over the past 20 years. The most familiar versions of WinNonlin (v3 – v5) were stand-alone Windows-based software packages used to perform non-compartmental analysis and single subject non-linear model […]

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What are direct and indirect pharmacodynamic models?

Nathan Teuscher

When constructing pharmacodynamic (PD) models, you will often encounter the adjectives “direct” and “indirect” describing the associated PD model. This terminology was very confusing to me when I was learning about PD modeling. Hopefully a brief explanation will help you. Let’s start with the direct PD model. In this type of model, the drug is […]

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What is a half-life?

Nathan Teuscher

One of the most incorrectly used but most often quoted parameters is half life. The symbol for half-life is t1/2. The reason for the multitude of errors with half-life is that in most cases, the assumptions required to use half-life correctly are rarely valid. And when the assumptions are false, the derived interpretations are also […]

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