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Case Studies: QbD for ANDAs

    Case Studies: QbD for ANDAs

    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:

    Quality by Design for ANDAs: An Example for Modified Release Dosage Forms

    Quality by Design for ANDAs: An Example for Immediate-Release Dosage Forms

    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.

    –Paul Thomas

     

     

     

    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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    One Response to “Case Studies: QbD for ANDAs”

    1. John Walker says:

      This is not Rocket Science.

      If you can’t show the statistical risk of accepting your evidence for distributing your drug, whether generic or new, then they, the FDA, are REQUIRED to challenge your right to distribute it.

      The only scientifically sound way of asserting the risk is by QBD. i.e. demonstrating PROFOUND knowledge of the process by which drugs are manufactured, linked back to clinical trials, to justify a drugs distribution.

      If you can’t, you should not be allowed to distribute the drug.

      What’s difficult to understand ??

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