W
WisdomseekerSC
I don't want to "reinvent the wheel" on this one. I have ICH documents for Stability Testing of New Drug Substance and Products that I am reading now...seems like someone who has more experience with this than I might be willing to share a template...I realize many variables exist depending on anticipated storage conditions and shelf-life expectations. My current case involves absorbable (resorbable) polymeric resins, sensitive to temperature and humidity in particular. These resins can be used as "excipients" by customers, so we need to establish shelf-life and retest dates.:
PS I am in US...whatever climatic zone that is I or II, I think.
PS I am in US...whatever climatic zone that is I or II, I think.
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