Determining the Best Estimate of Probability of Passing Multiple Stage Tests: Part 2—Dissolution

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.

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).