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

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 & Simulation

What is Quantification Anyway?

Nathan Teuscher

Bioanalytical analysis is a fundamental tool for the pharmacokineticist. The results of a bioanalysis are the source data for all pharmacokinetic work. Thus a clear understanding of the methodologies and challenges associated with the bioanalytical analysis science is of great benefit to a pharmacokineticist. As an example, I was recently working on the development of […]

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Topics: PK/PD Modeling & Simulation
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