A comparison of spiking experiments to estimate the detection proportion of qualitative microbiological methods
Author:
Affiliation:
1. Center for Mathematical Sciences, Merck Sharp & Dohme, Oss, The Netherlands
2. Department of Mathematics and Computer Science, Eindhoven University of Technology, Eindhoven, The Netherlands
Publisher
Informa UK Limited
Subject
Pharmacology (medical),Pharmacology,Statistics and Probability
Link
https://www.tandfonline.com/doi/pdf/10.1080/10543406.2018.1452027
Reference21 articles.
1. On the Compound Generalized Poisson Distributions
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1. Non-inferiority testing for qualitative microbiological methods:Assessing and improving the approach in USP <1223>;Journal of Biopharmaceutical Statistics;2022-09-21
2. Optimal Spiking Experiment for Noninferiority of Qualitative Microbiological Methods on Accuracy With Multiple Microorganisms;Statistics in Biopharmaceutical Research;2022-02-02
3. Validation Parameters as Applied to Methods for Quantification of Microorganisms in Medicinal Products;The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products;2020-12-11
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