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  1. Article

    Open Access

    Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development

    The emerging use of qPCR and dPCR in regulated bioanalysis and absence of regulatory guidance on assay validations for these platforms has resulted in discussions on lack of harmonization on assay design and a...

    Amanda Hays, Mark Wissel, Kelly Colletti, Russell Soon, Mitra Azadeh… in The AAPS Journal (2024)

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