Limin Shi

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Shi has a PhD, is a Senior Scientist, Pharmaceutical Development at Upsher-Smith Laboratories. His key responsibilities include leading pharmaceutical formulation and process development. His expertise ranges from crystallization, amorphization, drug solid-state stability, drug solubilization, direct compression, and granulation, to spray drying, and coating. He earned his doctor of materials science degree from Tsinghua University, China.

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Technical
Statistical Approach for CU Testing CPV Batches & Comparison with USP <905> UDU

The USP <905> UDU test, widely used for batch release since 2007, is no longer supported by FDA. We propose a two-sided tolerance interval method to alleviate this deficiency. The approach provides 50% confidence and 95% probability that future samples from the batch will conform to USP <905> criteria. In addition, this new statistical assessment provides the same practical...