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Psychiatry 19 , 834841 (2014)

To view or add a comment, sign in This week's FDA Warning Letter to Par Health / Endo USA is a strong reminder that Sterility assurance must be inherent to "process design" and consistently demonstrated in operation

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There is also ongoing debate about the most suitable product categorywhether food, supplement, or drugand about how to standardize measures of potency, viability, and functional outputs for strains whose benefits may vary significantly depending on context, including baseline microbiome, diet, and host genetics