Some Thoughts on a Recent US FDA Document “Quality by Design for ANDAs: An Example for Modified Release Dosage Forms”

The US FDA (CDER) released a document on the above mentioned title (Link). This single spaced 161-page long document provides an example of conducting and reporting studies for developing generic drug products as per the QbD (Quality by Design) approach.

It appears that this document may also be considered a “How-to manual on drug dissolution testing”, as a significant portion of the document describes the development and application of the dissolution testing.

It may be argued that if current practices of drug dissolution testing would not have faced so many problems/deficiencies and uncertainties, the procedures and documentations provided would certainly be simpler and shorter. Therefore, indirectly, the document may be considered as a long awaited recognition of the fact that current practices of drug dissolution testing are complicated and complex, and may not be working as well as one should expect.(please click here for complete post).

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