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The author introduces a practical approach to determining the best estimate of probability for passing multiple stage dissolution tests.
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 part one of this article. In this second half, the author introduces a practical approach to determining the best estimate for probability of passing the dissolution test using probability versus lot coverage charts and tables. The charts and tables were constructed using simulated probability and lot coverage data. The “best estimate” concept is to demonstrate that the probability estimates, especially for those very close to 100%, are just slightly deviated from the exact calculated values by not more than the statistically acceptable deviation limits.
Submitted: Aug. 30, 2021
Accepted: March 4, 2022
Pramote Cholayudth, firstname.lastname@example.org, 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.
Vol. 46, No. 4
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).