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Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin

  • 1.  Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin

    Posted 11-Jul-2018 17:18
    Hello:
    What is your opinion regarding the DRAFT GUIDANCE, ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin?
    Do we need to performance a extensive clinical study or a bioequivalence PK is enough?

    Thanks in advance!

    Alejandra Cruz
    Project Leader

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    Alejandra Cruz
    México
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