This AAPS publication offer general considerations and examples of experimental design and acceptance criteria for qPCR and dPCR assays that are used to support gene and cell therapies.
Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development - The AAPS Journal
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| Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development - The AAPS Journal |
| 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 appropriate acceptance criteria for these assays. Both qPCR and dPCR are extensively used to answer bioanalytical questions for novel modalities such as cell and gene therapies. |
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Pankajini Mallick PhD
Principal Scientist, Preclinical Pharmacokinetics | DMPK
San Diego CA
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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