Fasheng Li

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Fasheng Li is Director of Statistics in the Pharmaceutical Sciences and Manufacturing Statistics
group at Pfizer. With more than 15 years of experience in the pharmaceutical industry, he has
worked in design, analysis, and reporting of studies across the drug development life cycle.
His interests include drug product formulation and manufacture process optimization, drug
substance particle-size characterization, analytical method development, and applications of
QbD. Fasheng holds a PhD in statistics from the State University of New York

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Interpretation of Variance Components for Blend and Content Uniformity
Technical
Interpretation of Variance Components for Blend and Content Uniformity

Despite introducing modern analytical technology to assess blend uniformity, many companies are still using traditional blend sampling thieves and wet chemistry to assess blend homogeneity. The use of statistically based sampling plans allows variance component analysis to be conducted on both blend and dosage unit data. This article shows how various combinations of blend and dosage unit...