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News|Articles|April 2, 2022
- Pharmaceutical Technology, April 2022
- Volume 46
- Issue 4
- Pages: 40–45
Determining the Best Estimate of Probability of Passing Multiple Stage Tests: Part 2—Dissolution
Author(s)Pramote Cholayudth
The author introduces a practical approach to determining the best estimate of probability for passing multiple stage dissolution tests.
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Determining the probability of meeting content uniformity can be done through estimation by using probability vs. lot coverage charts and tables constructed from simulated probability and lot coverage 1 data, as discussed in
Peer-reviewed research
Submitted: Aug. 30, 2021
Accepted: March 4, 2022
About the author
Pramote Cholayudth, [email protected], is the founder and manager of PM Consult. He is an industrial pharmacist with more than 40 years of experience. He is a guest speaker on process validation to industrial pharmaceutical scientists organized by Thailand’s FDA.
Article details
Pharmaceutical Technology
Vol. 46, No. 4
April 2022
Pages: 40–45
Citation
When referring to this article, please cite it as P. Cholayudth, “Determining the Best Estimate of Probability of Passing Multiple Stage Tests: Part 2—Dissolution,” Pharmaceutical Technology 46 (4) 40–45 (2022).
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