Minimizing Experimental Testing on Fish for Legacy Pharmaceuticals.

ABSTRACT: There was no regulatory requirement for ecotoxicological testing of human pharmaceuticals authorized before 2006, and many of these have little or no data available to assess their environmental risk. Motivated by animal welfare considerations, we developed a decision tree to minimize in vivo fish testing for such legacy active pharmaceutical ingredients (APIs). The minimum no observed effect concentration (NOEC_min, the lowest NOEC from chronic Daphnia and algal toxicity studies), the theoretical therapeutic water concentration (TWC, calculated using the fish plasma model), and the predicted environmental concentration (PEC) were used to derive API risk quotients (PEC/NOEC_min and PEC/TWC). Based on a verification data set of 96 APIs, we show that by setting a t

SUBMITTER: Coors A 

PROVIDER: S-EPMC9893720 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature