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The US Food and Drug Administration's current guidance is based on dose by factor approach where the NOAEL of drug is scaled by making use of allometry to derive the maximum recommended starting dose (MRSD) for clinical studies.[7] This simple empirical approach considers the sizes of individual species based on body surface area which is related to metabolic rate of an animal that is established through evolutionary adaptation of animals to their size.[8,9] Moreover, the MRSD is usually scaled well across animal species when normalized to body surface area (mg/m 2 )

Yet, without addressing glutathione stability, even the best intentions falter

Some researchers splitting doses inject morning and evening

One commenter explained that it is important to minimize the reopening of previous years to avoid a perception of instability for the program, and recommended CMS avoid reopening previous years' financial determinations without significant reasons. Response: We appreciate commenters' support for the approach we specified in the CY 2025 PFS proposed rule under which we would consider limiting the instances in which we reopen an initial determination to account for improper payments, pursuant to 425.315(a), to strike a balance between improving the accuracy of the calculations and ACOs' and CMS' interest in administrative finality of payment determinations