Regulatory Open Forum

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  • 1.  in vitro toxicology study in human tissues, module 4 or 5?

    Posted 18-Oct-2011 17:50

    Where does an in vitro study performed on human cells/tissues belong in the CTD: clinical or nonclinical?  The objective of such a study could be to show lack of a toxic effect of an investigational medicinal compound on the cell's proliferation, etc.  So the study is toxicology but in human tissues.



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    Clarisse Stone RAC
    Manager, Electronic Documents
    Galderma R&D
    Cranbury NJ
    United States
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  • 2.  RE:in vitro toxicology study in human tissues, module 4 or 5?

    Posted 19-Oct-2011 09:32
    I had studies to demonstrate permeability of product in  human tissue and I have put those in Module 4.  The FDA reviewer did not say anything about it.
    Catherine

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    Catherine Bernard ScD
    Pres
    International Regulatory Affairs Services Inc
    Highlands Ranch CO
    United States
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    Original Message


  • 3.  RE:in vitro toxicology study in human tissues, module 4 or 5?

    Posted 19-Oct-2011 12:58
    In vitro human tissue studies are commonplace in pharmacology, ADME and toxicology studies and are placed in Module 4.  It is a good idea to cross-reference, however, in Module 5. Good luck!

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    Susan Meier-Davis, DVM, PhD, DABT, RAC
    Director, Pharm/Tox
    Teikoku Pharma USA
    San Jose CA
    United States
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    Original Message


  • 4.  RE:in vitro toxicology study in human tissues, module 4 or 5?

    Posted 20-Oct-2011 13:54

    I agree with the other posters; these studies belong in Module four.  Although in human tissues, they are not clinical studies but nonclinical studies.

    Alice
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    Alice Varga
    Sr. Consultant
    BCG
    Brisbane CA
    United States
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    Original Message


  • 5.  RE:in vitro toxicology study in human tissues, module 4 or 5?

    Posted 19-Oct-2011 15:36

    From my experience toxicology studies falls under module 4 (non-clinical), but cross reference to module 5  may not be a bad idea.
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    Marc Sanchez
    Attorney and Consultant
    Atlanta GA
    United States
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    Original Message