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Vigorous agitation creates foam and can denature the peptide through mechanical shearing
It focuses on the sterility of the compounding environment but does not require the same level of finished product testing or process validation as CGMP
Zelniker TA, Wiviott SD, Raz I, Im K, Goodrich EL, Bonaca MP, et al
The time periods considered for analyzing changes over time were 19801994, 19952005 and 20062015, giving priority to periods of similar length rather than to sample size
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