An IVRT method was developed and validated to confirm its reproducibility, precision,\nsensitivity, selectivity, accuracy, robustness, and reliability. A novel approach was used to demonstrate\nthe appropriateness of the IVRT method to accurately assess â??samenessâ? between topical products\nand to confirm that the methodology applied also possesses the requisite discriminatory power to\ndetect differences should such differences exist between products. In the first instance, the reference\nproduct (Metrocreme®) containing 0.75% metronidazole (MTZ) was tested against itself as a positive\ncontrol, to accurately demonstrate â??samenessâ?, where the results met the relevant acceptance criteria\nfalling within the limits of 75â??133.33% in accordance with the FDAâ??s SUPAC-SS guidance. In addition,\ntwo specially prepared creams containing 25% less and 26% more MTZ, i.e., 0.563% and 0.945%,\nserved as negative controls and were compared............
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