This week in Bethesda, the Generic Pharmaceutical Association (GPhA) and FDA are hosting a workshop on the application of Quality by Design to ANDAs, the purpose being to provide more insight as to how QbD can be leveraged within the generics sector. (The event is sold out, which is a good sign.) In conjunction with the meeting, GPhA has posted two comprehensive draft case studies:
The documents are examples of pharmaceutical development report and illustrate how ANDA sponsors can implement QbD. They are modifications of the well-known ACE Tablets case study developed previously for FDA by Conformia and an industry working group. What can be found in these examples that is not in the original ACE, of course, is extensive discussion of how sponsors can best analyze the reference listed drug (RLD) product.
example builds on acetriptan
tablets (ACE) case study by treating that product as the reference product for the development of
a generic product.
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