5\eta } \right)-\sqrt \eta \hat \pi \left( 1 - \hat \pi \right) + 0.30\eta^2 } \right\} where $$\eta = \fracZ_One -- any^2\hat \sigma_\hat \pi ^2\hat \pi \left( One : \hat \pi \right)$$ and Z 1???�� is the upper (1???��) quantile of the standard normal distribution. Note that the containment-proportion approach corresponds to the same statistical hypothesis test as the tolerance-interval approach. The null hypothesis is H 0: ��?https://www.selleckchem.com/products/Paclitaxel(Taxol).html the null hypothesis (and therefore accept the bioanalytical method) if the (1???��) one-sided lower confidence bound �� L is greater than or equal to ��. Similar to the tolerance-interval approach, implementation of a containment-proportion approach requires appropriate choices of the required proportion (��), one-sided confidence level (1???��), and acceptance limits (A, B). For assessment of incurred sample reproducibility, 66.7% required proportion and 95% confidence are logical choices. As previously described above, acceptance limits of ��log(1.212) for log-transformed data are proposed. Thus, the proposed containment-proportion approach consists of constructing a 95% one-sided lower confidence bound for the proportion of log-scale differences which are contained within the ��log(1.212) acceptance limits. If the resulting lower confidence bound is greater than or equal to the required proportion ��?=?66.7%, the ISR test is passed; otherwise, thiram the ISR test is failed. Like the tolerance-interval approach, the containment-proportion approach proposed above strictly controls the risk of incorrectly accepting a truly non-reproducible method. Regardless of the sample size, this risk is no greater than 5% (i.e., ��%). The risk of incorrectly rejecting a truly reproducible method with the containment-proportion approach must be controlled by appropriate choice of Cisplatin cell line sample size. The simulation study described above for the tolerance-interval approach was also used to provide general guidance on the number of incurred samples required for ISR experiments when the acceptance criteria are based on the proposed containment-proportion approach. Figure?8 gives the probability of failing an ISR test based on the containment-proportion approach versus the number of incurred samples, for true total CV?=?10.0%, 11.0%, and 12.0%. Fig.?8 Probability of failing ISR test versus number of incurred samples, for true total CV?=?10.0%, 11.0%, and 12.0%. True relative bias is 0%. Acceptance criteria based on containment-proportion approach The results in Fig.