Adequacy and verifiability of pharmaceutical mixtures and dose units by variographic analysis (Theory of Sampling) – A call for a regulatory paradigm shift

Title
Adequacy and verifiability of pharmaceutical mixtures and dose units by variographic analysis (Theory of Sampling) – A call for a regulatory paradigm shift
Authors
Keywords
Theory of Sampling, TOS, Blend uniformity analysis (BUA), Variographic analysis, Measurement uncertainty, Sampling paradigm shift, Regulatory science, Quality control
Journal
INTERNATIONAL JOURNAL OF PHARMACEUTICS
Volume 499, Issue 1-2, Pages 156-174
Publisher
Elsevier BV
Online
2015-12-19
DOI
10.1016/j.ijpharm.2015.12.038

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