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Activity Number:
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166
- Non-Clinical Statistics, Personalized Medicine, and Other Topics
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Type:
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Contributed
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Date/Time:
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Tuesday, August 10, 2021 : 10:00 AM to 11:50 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #318136
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Title:
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In Vitro Dissolution Profile Comparison Using Bootstrap Bias Corrected Similarity Factor, F2
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Author(s):
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Xiaoyu Cai* and Shaobo Liu and Meiyu Shen and Yi Tsong
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Companies:
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U.S. Food and Drug Administration and U.S. Food and Drug Administration and Office of Biostatistics CDER, FDA and CDER, US FDA
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Keywords:
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Dissolution profile comparison;
Similarity factor f2;
Bootstrap confidence interval;
Bias correction
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Abstract:
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Various methods have been developed to assess the similarity between two dissolution profiles. In particular, similarity factor f2 has been reviewed and discussed extensively in many statistical articles. Although the f2 lacks inferential statistical properties, the estimation of f2 and its various modified versions were the most widely used metric for comparing dissolution profiles. In this paper, we show that naïve f2 estimate method and BCa Bootstrap f2 confidence interval method are unable to control the type I error rate. The Bootstrap f2 confidence interval method can control the type I error rate under a specific level. However, it will cause great conservatism on the power of the test. We proposed a Bootstrap Bias Corrected (BC) f2 confidence interval method in this paper. The type I error rate, power and sensitivity among different f2 methods were compared based on simulations. Our proposed Bootstrap BC f2 confidence interval method shows better control of type I error than the naïve f2 estimate method and BCa Bootstrap f2 confidence interval method. It also provides better power than the Bootstrap f2 confidence interval method.
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Authors who are presenting talks have a * after their name.
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