Data can be the most important aspect of a GxP organization. Storage complexity and requirements are increasing, and cloud solutions can be an attractive option for maintaining this ever-growing pool of data. When considerations…

If you’re running a clinical or preclinical study, there are many components that you need to think about, plan, and execute. One is “what the heck do I do with these samples we’re collecting”…

The FDA has regulated cigarettes, smokeless and loose tobacco since 2009 under the Tobacco Control Act. In 2016, the FDA finalized a rule for the regulation of all tobacco products, making it illegal to sell e-cigarettes, cigars and hookah tobacco to anyone under 18 and requiring retailers to check photo…

Surprisingly, there are a number of drug development companies that do not obtain stable isotope-labeled internal standards (SIL-IS) for their bioanalytical methods. Instead they settle for using a surrogate internal standard (a compound that closely resembles the measured analyte) which can lead to unreliable data and be detrimental to a…

Like the old adage, “you get out of it what you put into it,” good study design is a prerequisite of good data. To boost the chances of generating accurate and informative facts over the course of a study, it is key to consider all of the supporting parameters that…

There is regulatory requirement that the cumulative time a frozen pharmacokinetic sample has been thawed – from the time it’s removed from the freezer to the time it’s returned – be documented. Freeze/thaw cycle data is not deemed sufficient alone, since a study sample might have been thawed for extended…