Has it ever occurred to you what would happen if the conditions applied during the development of an analytical method would vary? In this article we will address the same question through the parameter called robustness, which can be evaluated during method validation if not yet done earlier e.g. during method qualification.

In our blog today, we will explain the term trueness in the context of method validation, as well as its calculation, highlight its importance and provide some information about what is required.

In our blog article today, we would like to take a short look on the analytical method validation parameter “precision” and explain the different terms repeatability, intermediate precision and reproducibility.

If you are working within the pharmaceutical industry or are somehow related to it, you must have come across the terms; Drug Substance, Drug Product, and Excipients. Although simple, many people make obvious mistakes dealing with them. In this short article, we wrote a brief overview about the terms with supporting examples.