Developing a Successful Assay for Active Pharmaceutical Ingredients

The process of developing an assay mainly depends on the nature of the pharmaceutical article for which it is developed. This pharmaceutical article can be an active pharmaceutical ingredient (API) raw material of natural origin, a small molecule, or a biopharmaceutical macromolecule; alternatively, it can be a finished product with one or several APIs and excipients.

In this list, we discuss the process of developing an assay – a crucial test during various stages of drug discovery and development – highlighting the factors that impact the process.

Download this list to learn about:

• How the nature of the assayed material impacts assay development
  
• The specificity and selectivity of an assay
• The analytical techniques used for assays