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Reconstituting in unbuffered water and assuming neutral pH leads to variability
For example, cystic fibrosis patients suffer from severe gram-negative bacterial infections and are commonly prescribed the aminoglycoside antibiotics amikacin or tobramycin, despite as high as a 14% incidence of hearing loss (Cheng et al., 2007
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European Medicines Agency (EMA) approval pathways for peptides are generally similar to FDA processes, facilitating concurrent development for both markets
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