Statistical Evaluation of the Potency of Test Sample Lots

Objective: The significance of this project lies in the unique opportunity it affords to test the evaluation of test sample lots for the In Vitro Relative Potency (IVRP) of the Human Papilloma Virus Types 6,11,16,18 Virus Like Particles. The problem being addressed by this project is how to develop and design statistical procedures for testing potency for the released lot of drug/product. The three questions needed to answer in order to create the best fitted procedure are: 1) Minimum possible steps needed to reach the best results, 2) How many results should be used to calculate % Relative Standard Deviation (%RSD) at each step (2 or 3)?, and 3) Should all samples be used or just the non-deleted ones (without the extremes deleted at each step). Methods: The study was based on a simulation data set compiled using SAS® program in a sequential sampling manner. A procedure of calculations was created in order to test the potency using the %RSD. If the %RSD is less than 20% then the test is significant, otherwise it must be repeated to reach this %RSD. The three questions were answered during the study using graphs compiled from the simulation data results. There were three sets of graphs generated in this study, which were compared to create the new procedure. Set 1: Compares the |Bias| and MSE of log-[mu] and sigma of three, four, and eight steps with seven different levels of CV. Each level of CV has six different values (three for |bias| and three for MSE). Set 2: Compares using all numbers vs. non-deleted numbers of the |Bias| and MSE of log-[mu] and sigma for each separate CV while adding three additional samples or two additional samples. Set 3: Compares having two additional samples vs. three additional samples of the |bias| and MSE for log-[mu] and sigma for each separate CV while using all numbers or non-deleted numbers. Results: Based on the Bias and MSE graphs the main findings were that the procedure should include: Three steps, three additional samples should be chosen in each step rather than two, and only the non-deleted numbers should be used to calculate the potency. Conclusions: The main finding of this study shows that the original procedure should be altered. The original procedure stated that all of the numbers should be used, however the findings suggest that only the non-deleted numbers should be used to calculate the potency. In order for this study to be applicable some of the data should become contaminated for a better representation of real life. This study was proven to be effective because alterations to the procedure will help to calculate the potency for future vaccine lots.