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Phil Borman, DSc, has served in multiple quality-related roles at GlaxoSmithKline; as of April 2021, he is senior fellow and director of product quality.
Timothy Schofield is owner and consultant, CMC Sciences, LLC;
David Lansky, PhD, is president, Precision Bioassay, Inc.
A well-chosen replication strategy can effectively reduce the uncertainty for an analytical method, enabling appropriate decisions regarding pharmaceutical quality.
For a robustly developed analytical method, a well-chosen replication strategy can effectively reduce the uncertainty. A statistically sound approach involves replicating the factors associated with large amounts of variation followed by an appropriate analysis. The amount of reduction in uncertainty needed is informed by the precision requirements of the analytical target profile (ATP), ensuring that risks of making inappropriate quality decisions are minimized.
In this article, the authors describe two case studies: the use of a high-performance liquid chromatography separation method for a small-molecule API and a bioassay for a biopharmaceutical or vaccine.
Phil Borman, DSc, is senior fellow and director of product quality, GlaxoSmithKline; Timothy Schofield is owner and consultant, CMC Sciences, LLC; and David Lansky, PhD, is president, Precision Bioassay, Inc.
Vol. 45, No. 4
When referring to this article, please cite it as P. Borman, T. Schofield, and D. Lansky, “Reducing Uncertainty of an Analytical Method through Efficient Use of Replication,” Pharmaceutical Technology 45 (4) 2021.