Therapeutic Solutions International Inc (TSOI)

[Rymung]

Knowledge is power, certainly.
Isn’t that something…”shelf lives” “difficult to draft uniform guidelines” “shelf lives for existing products and potential future products will be within the range of 0.5 to 5 years”

.05 to 5 years. Shelf life. Assay. Maturity. 👍🤓

“VII. TESTING FREQUENCY (7)
The shelf lives of biotechnological/biological products may vary from days to several years. Thus, it is difficult to draft uniform guidelines regarding the stability study duration and testing frequency that would be applicable to all types of biotechnological/biological products. With only a few exceptions, however, the shelf lives for existing products and potential future products will be within the range of 0.5 to 5 years. Therefore, the guidance is based upon expected shelf lives in that range. This takes into account the fact that degradation of biotechnological/biological products may not be governed by the same factors during different intervals of a long storage period.
8
When shelf lives of 1 year or less are proposed, the real-time stability studies should be conducted monthly for the first 3 months and at 3 month intervals thereafter. For products with proposed shelf lives of greater than 1 year, the studies should be conducted every 3 months during the first year of storage, every 6 months during the second year, and annually thereafter.
While the testing intervals listed above may be appropriate in the preapproval or prelicense stage, reduced testing may be appropriate after approval or licensure where data are available that demonstrate adequate stability. Where data exist that indicate the stability of a product is not compromised, the applicant is encouraged to submit a protocol that supports elimination of specific test intervals (e.g., 9-month testing) for postapproval/postlicensure, long-term studies.“

Bury that, MHG. Give ANP my best! 👻
2010-2024, what a waste of potential.

https://www.fda.gov/media/71441/download