The Changing Face of Bioanalysis

This is a pharmaceutical industry perspectiv of the way bioanalytical technologies are changing in response to the changing types of molecules under development and the regulatory drivers required to "prove" effectiveness.

In this context bioanalysis is used to mean the measurement of drugs in biological fluids not the technologies used to elucidate and characterize the structure of biologicals.

Introduction

What are the drivers for change? Are they the same now as in past? What has changed now? Perhaps one of the earliest drivers for change was pharmacokinetics, a science whose origins can be traced back to 1930s, [1]

concerned with the mathematics of drug absorption, distribution and excretion. It was not until the 1950/60s that it became widely used by drug developers to modify and monitor the development of their formulations. An important aspect of drug development was the need to relate the pharmacokinetics and metabolic profile of the drug in animal safety testing with those in Human. Nevertheless drug plasma levels still lacked a "direct" relationship to the pharmacological response. "We don’t make drugs (in this case a diuretic) for their plasma levels, we make them for their effects" so said a Big Pharma Research Director when told in the 1970s that the techniques used to measure the plasma levels were too insensitive, although the physiological effects were obviously quantifiable.