Robert Holt, PhD, associate director, Pharmaceutical Science, digiM Solution, discusses microstructure intelligence in more detail in part 2 of this preview of the company’s keynote presentation at AAPS PharmSci 360.
News|Articles|April 2, 2021
- Pharmaceutical Technology-04-02-2021
- Volume 45
- Issue 4
Reducing Uncertainty of an Analytical Method through Efficient Use of Replication
A well-chosen replication strategy can effectively reduce the uncertainty for an analytical method, enabling appropriate decisions regarding pharmaceutical quality.
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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.
About the authors
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.
Article Details
Pharmaceutical Technology
Vol. 45, No. 4
April 2021
Pages: 46–56
Citation
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.
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Advanced Manufacturing Technologies Shift Outside the Boxover 5 years ago
Reshoring and Expanding API Manufacturing Capabilitiesover 5 years ago
Balancing the Art and Science of Topical Drug Formulationover 5 years ago
Focusing on Accelerated Formulation Strategiesover 5 years ago
Understanding the Impact of Annex 1 on Isolator Operationover 5 years ago
Blocking the Threat of Counterfeit Medicinesover 5 years ago
Limitations and Advances in Dissolution TestingAdvertisement
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