A Validated IVRT Method to Assess Topical Creams Containing Metronidazole Using a Novel Approach.

ABSTRACT: An IVRT method was developed and validated to confirm its reproducibility, precision, sensitivity, selectivity, accuracy, robustness, and reliability. A novel approach was used to demonstrate the appropriateness of the IVRT method to accurately assess "sameness" between topical products and to confirm that the methodology applied also possesses the requisite discriminatory power to detect differences should such differences exist between products. In the first instance, the reference product (Metrocreme®) containing 0.75% metronidazole (MTZ) was tested against itself as a positive control, to accurately demonstrate "sameness", where the results met the relevant acceptance criteria falling within the limits of 75-133.33% in accordance with the FDA's SUPAC-SS guidance. In addition, two speci

SUBMITTER: Rath S 

PROVIDER: S-EPMC7076423 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature