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ICH Q2(R2) provides a general framework for validating analytical procedures, including principles that apply to chromatographic and spectroscopic data [14]

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For test subjects on a 2,000 g/week dosing schedule, this would equate to five 400 g injections per week or twice-daily 200 g doses

2021;33(43) doi: 10.1002/adma.202102668

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