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What Has Changed in Method Development and Validation for Pharmaceuticals and Why You Need to Know

What Has Changed in Method Development and Validation for Pharmaceuticals and Why You Need to Know

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...
The Role of Stability-Indicating Methods to Determine the Potency of an API

The Role of Stability-Indicating Methods to Determine the Potency of an API

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...
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