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RAPID METHOD TO PREDICT STABILITIES OF PHARMACEUTICAL COMPOSITIONS CONTAINING PROTEIN THERAPEUTICS AND NON-REDUCING SUGARS
RAPID METHOD TO PREDICT STABILITIES OF PHARMACEUTICAL COMPOSITIONS CONTAINING PROTEIN THERAPEUTICS AND NON-REDUCING SUGARS
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机译:预测含有蛋白质治疗剂和非还原糖的药物组合物稳定性的快速方法
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摘要
Provided is a method of determining the stability increase provided by a non-reducing sugar in a pharmaceutical composition containing a protein therapeutic, the method comprising: (i) providing: a first pharmaceutical composition comprising an aqueous solution of the protein therapeutic in the substantial absence of a non-reducing sugar, wherein the first pharmaceutical composition has a first B22 value and a second pharmaceutical composition comprising an aqueous solution of the protein therapeutic and the non-reducing sugar, wherein the second pharmaceutical composition has a second B22 value; (ii) determining the difference between the first and second B22 values; and (iii) predicting the stability increase provided by the non-reducing sugar based on the difference in B22 values.
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