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The October 2022 draft United States Food and Drug Administration (FDA) guidance presents an option of in vitro release test (IVRT) studies as a biowaiver for topical drug products submitted in abbreviated new drug applications (ANDAs). However, the product-specific guidance (PSG) for 1% clotrimazole (CLZ) topical cream does not provide an in vitro option for biowaiver and requires a clinical endpoint study to demonstrate bioequivalence (BE). Therefore, the main objective was to use IVRT to investigate pharmaceutical equivalence of several 1% CLZ topical creams from two countries — South Africa (SA) and Canada. This investigation aims at demonstrating the utility of IVRT to determine 'sameness' and/or differences between topical creams containing 1% CLZ and the potential of IVRT for supporting biowaivers, thereby obviating the necessity to conduct clinical endpoint studies in patients. A validated IVRT method was applied to conduct comparative IVRT runs on five generic products marketed in SA and one Canadian generic, which were compared against a relevant comparator product from their country of origin in accordance with the FDA's acceptance criteria of 75–133.33%. All five SA-marketed generic creams showed pharmaceutical inequivalence to the SA comparator product indicating Q1/Q2/Q3 differences. Despite containing the same excipients as both comparator products, the Canadian generic showed substantially lower release rate compared to the comparator products which could be attributed to Q2/Q3 differences. The IVRT method displayed the requisite ability to assess the various 1% CLZ creams and confirmed the potential of the IVRT method to support a biowaiver for 1% CLZ topical creams. [ABSTRACT FROM AUTHOR] more...

The former South African first black President's vision aimed to unite and fight racial tensions and inequalities by introducing and envisioning a South Africa for all who live in it. However, twenty-five years later, the post-apartheid South Africa is riddled with cancerous ills such as racial inequality, racism, and failure to bridge the gap between the poor and the rich. This paper will attest to the notion that the 1994 rainbow nation ideology is dead because racial inequality is still a norm, and that the implication of the negotiated settlement has preserved racial inequality and its core racist foundations. The ideology of the "rainbow nation" has failed to erode racial inequality in South Africa. It has failed to close the gap between the poor and the rich and most importantly, the "rainbow nation" ideology has shown that it was a one-sided concord dependent on whose privilege matters most and not a collective view to addressing racial inequality. Black South Africans have, therefore, continued to bear the brunt of poverty, unemployment and inequality compared to white South Africans. I argue that the "rainbow nation" has failed to address racial inequality and build the imperative ideology of sameness and togetherness. I will employ a standard method of applied analytical philosophy to perform this task, which is grounded in critical conceptual analysis and systematic rational argumentation. [ABSTRACT FROM AUTHOR] more...