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Grounds MD, Radley HG, Gebski BL, Bogoyevitch MA, Shavlakadze T
More recent studies show us the why
Experts increasingly advocate aligning safety expectations for high-risk probiotic products (e.g., LBPs) with those applied to other complex biologicals, including systematic genomic characterization, standardized adverse-event reporting, and structured post-market surveillance, while avoiding unnecessarily stricter requirements than for comparable biologic therapies (525)
2.2 Blood sampling and consent form On the day of AAV diagnosis, informed consent was obtained, AAV-specific indices were assessed, and whole blood was collected from patients with AAV
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