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Author:
Date:
2014-11-05
[Abstract] The purpose of stability testing is to determine how the properties of a particular therapeutic vary with time under the influence of specific environmental factors. Information regarding the long-term stability of therapeutics can be extrapolated by performing an accelerated storage stability study. Here, we describe an accelerated storage stability study for the potential anti-anthrax therapeutic, EnvD, a poly-γ-D-glutamic acid (PDGA) depolymerase. Storage conditions were based on those recommended by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Owing to the high-molecular-weight and associated viscosity of PDGA in solution, loss of enzyme activity on storage can be determined as a reduction in the ...
[摘要] 稳定性测试的目的是确定特定治疗剂的性质在特定环境因素的影响下如何随时间变化。 关于治疗剂的长期稳定性的信息可以通过进行加速的储存稳定性研究来外推。 在这里，我们描述了潜在的抗炭疽治疗，EnvD，聚-γ-D-谷氨酸（PDGA）解聚酶的加速储存稳定性研究。 储存条件基于国际药品批准技术要求协调会议（ICH）的建议。 由于PDGA在溶液中的高分子量和相关的粘度，储存时酶活性的损失可以被确定为解聚酶降低聚合物粘度的能力的降低。 这项工作由医学研究委员会能力建设学生奖。
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