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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 #318370
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Title:
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Statistical Approaches for Shelf Life Determination of a Drug Product
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Author(s):
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Xutong Zhao* and Tengfei Li and Meiyu Shen and Yi Tsong
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Companies:
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CDER, US FDA and Georgetown University and Office of Biostatistics CDER, FDA and CDER, US FDA
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Keywords:
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shelf-life determination;
tolerance interval;
ANCOVA
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Abstract:
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Shelf life of a drug product is determined conventionally based on up to 24 months observed values for critical quality attributes from available batches prior to the regulatory approval of a new drug application. The data consists of three biobatches and is analyzed with the statistical method recommended in ICH Q1E. During the last 30 years, many statistical publications proposed a variety of approaches on the topic of shelf life determination especially when the number of batches used is larger than 3. Here, we compare two approaches of shelf life determination using various number of batches. One approach is the ANCOVA method by which the shelf life is determined by the worst batch if batches can’t be pooled and is otherwise determined by the pooled data of all batches. The other approach is based on the tolerance interval of a linear mixed model. The shelf life is determined by the lower confidence limit of the 5th percentile of shelf lives of all batches. These two approaches are compared using simulation studies.
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Authors who are presenting talks have a * after their name.
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