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Debora Regina Daga on Muck Rack

Debora Regina Daga

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Quality Control Optimization for Minimizing Security Risks Associated with Mesenchymal Stromal Cell-Based Product Development

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By Lidiane Maria Boldrini-Leite, Debora Regina Daga, Daniela Boscaro Marsaro, Isadora May Vaz
| MDPI
4. Materials and Methods 4.1. Study Design According to ANVISA regulations, all data about the manufacturing process must be submitted to regulatory authorities, which review the information and approve the protocol, if appropriate [3]. The protocol and quality controls described in this work are being used in a study approved by ANVISA for the treatment of pneumonia in patients with SARS-CoV-2 (N° 25351.076011/2021-44).
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