Statistical Comparison of Parallel-Line Symmetrical Microbiological Models: Analysis of Agar Diffusion Assay in 8 x 8 Large Rectangular Plates

Abstract

(1) Background: Microbiological assay of active medicinal compounds is superior to conventional chemical means in several circumstances to date. However, ensuring the validity and suitability of the assay design proposed for the intended purpose is crucial before deriving any records or conclusions from the results of the potency determination; (2) The present work represented statistical comparison between three design models for determination of the potency of Neomycin Sulfate antibiotic using agar diffusion technique for the same test material subject under identical conditions through the application of a combination of statistical software programs, including validated programmed Microsoft Excel Workbook for the statistical testing of each assay layout; (3) Results: raw data of the three assay designs were found to be reasonably valid for further analysis of the assay suitability. Examination of the sources of variations for each design demonstrated the validity of the conducted experimentation. Variation between the computed potencies from the three designs was lower than 5 µg/mg. However, there was significant variation between the confidence windows of each type; (4) Conclusions: 2 x 4 design had the narrowest confidence range. However, improving confidence would require investigation of the assay parameters, including the modification of the number of replicates per treatment.

Trending Perspective in Quality Control Monitoring and Investigation of Some Properties of Active Pharmaceutical Ingredient

“…The coefficient of variation for apparent density was relatively high Asian Sci. Bull., 2 (1): [24][25][26][27][28][29][30][31][32][33][34][35]2024 (10.23%), which indicated a high variability among the batches. The melting point had a low mean and median (125.9 and 126.0EC, respectively), which was lower than the reported range of 128-131EC.…”

“…Asian Sci. Bull., 2 (1): [24][25][26][27][28][29][30][31][32][33][34][35]2024 Process-behavior charts, also known as Shewhart charts or control charts, are widely used tools for monitoring and improving the quality of various processes and products 22,26 . Depending on the type of data, variable or attribute charts can be applied to track the variation and detect any signals of special causes 22,23 .…”

“…Two inspection characteristics failed to demonstrate suitable fitting for commonly used distributions such as gaussian and poisson spreading patterns 32,33 . Hence, modifying the data for Laney attribute charts was conducted with useful interpretable outcomes to evaluate the characteristics under study.…”