In order to provide the necessary data for an IND, you’ll need to apply some analytical chemistry to create methods for measuring your drug. For efficacy and exposure, you’ll need methods to measure the presence and concentration over time in in vitro samples (such as buffers, cell suspensions, and other simple or complex test solutions) as well as in vivo, in plasma and tissues. The methods you start with should be able to produce reliable data for initial decision making, but you’ll need validated analytical methods for development work such as animal toxicology and human trials.

When you are ready to produce your active molecule (drug substance) for human trials, you’ll need methods that will allow you to demonstrate that each batch is consistently pure and of appropriate strength. These same methods may be used to demonstrate that the dose formulation (drug product) is also pure, potent, and stable across the time frame of the studies.

These methods will ultimately be validated for use once your drug is approved (that is the point of your effort, right?), so I recommend you keep this in mind when starting method development in the early stages to avoid long term pain. For example, I’ve seen many validated HPLC methods that suffer from poor initial choices in terms of separation chemistry as well as choices along the way to ‘tweak’ the separation to meet interim goals, instead of starting over with a more robust approach. These stories seldom end well; therefore, my recommendation is make your key investment in robust analytical methods before you start making measurements.

Text Copyright © 2018 Katrina Rogers