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  • 1.  Multiple flavors for a liquid product

    Posted 22-Jun-2015 09:43
    Hello All,

    I'm working on a liquid ANDA product which we plan to make in different flavors.

    Do I need to do individual bioequivalence studies for each flavor or is there an alternative to this where I can have all the flavors in one matrix type of study?

    Appreciate all your help.



    Thanks,
    Mehul

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    Mehul Govani
    Regulatory Specialist
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  • 2.  RE: Multiple flavors for a liquid product

    Posted 23-Jun-2015 08:17
    Hello Mehul.

    While I am by no means an expert in this sort of thing, the logical conclusion is that if the flavor has no impact on biological absorption into the blood stream then there should be no significant issue with performing a matrix bioequivalence study.  That said, how you could "prove" this is open to further debate and discussion.

    My suggestion is to put together your matrix plan and discuss it directly with OGD.  They can then provide any additional guidance or necessary requirements that might impact your study and your ANDA review.  That way, you have gone through the process and utilized a method and analysis that the OGD personnel are comfortable with reviewing as a method.  Note - they may say you need to do all the flavors and if they do it might become difficult to change their minds.  However, knowing this position before you start your BE studies makes for a smoother process in the review...

    Obviously, these are just my thoughts and others may recommend differently.  I actually am eager to see what our colleagues think on this issue as it is always a balancing act between costs, time, and likelihood of first pass review/approval....

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    Victor Mencarelli
    Sr. Manager - Regulatory Affairs
    United States
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    Original Message


  • 3.  RE: Multiple flavors for a liquid product

    Posted 23-Jun-2015 20:47
    Victor and Mehul,

    My first reaction is how does the matrix approach represent the actual ANDA product in the end, data will be the driver, right?  I like the approach suggested by Victor but I would add that depending on timing, perhaps you move forward with the first flavor while in parallel you have the discussion with OGD and the others. I would love to know what you finally do! 

    All the best,

    Dar

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    Darlene Rosario RAC
    Principal Consultant RA, Quality and Compliance
    Velocity Consulting
    Ventura CA
    United States
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    Original Message


  • 4.  RE: Multiple flavors for a liquid product

    Posted 24-Jun-2015 14:33
    Great inputs. Victors answer sounds very logical. Having FDA aboard on the plan saves a lot of time in the end.

    I'll keep you posted on the outcome. Thank you all.

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    Mehul Govani
    Regulatory Specialist
    PL Developments
    Westbury NY
    United States
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    Original Message


  • 5.  RE: Multiple flavors for a liquid product

    Posted 24-Jun-2015 15:07
    typically a BE study is not needed for oral solutions and BE requirements are waived.  see the FDA guidance on BE studies as well as 320.22(b)(3).

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    Michael Hamrell, Ph.D., RAC, FRAPS
    MORIAH Consultants
    Huntington Beach CA
    United States
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    Original Message