by Mehdi Yazdi | Apr 8, 2021 | Analytical Methods, API Manufacturing, Blog, DMFs, FDA, Research and Development
The traditional approach for defining Drug Master Files (DMFs), New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs) is no longer acceptable. The expectations for analytical methods have changed over time and a successful filing depends on...
by Mehdi Yazdi | Nov 23, 2020 | API Manufacturing, Blog, Controlled Substance, Impurities, Stability Testing
Choosing a stability indicating method can be an effective route for detecting and quantifying the assay or potency of a chemical substance and its impurities profile. The ultimate goal of any method is to prove that, based on the profile of the drug and establishment...
