Miocardio/química; Troponina/análisis; Animales; Biomarcadores/análisis; Aprobación de Drogas; Humanos; Estados Unidos; United States Food and Drug Administration

Analytical; BQRT; Biomarker Qualification Review Team; Biomarkers; CDER; CLSI; Cardiac troponins; Center for Drug Evaluation and Research; Clinical and Laboratory Standards Institute; DDT; Drug Development Tool; Drug Development Tools; ELISA; FDA; Food and Drug Administration; H&E; HESI; Health and Environmental Sciences Institute; Histopathology; ILSI; IND; International Life Sciences Institute; Investigational New Drug; LOD; LOI; NDA; NOAEL; New Drug Application; Qualification; Safety assessment; enzyme-linked immunosorbent assay; hematoxylin and eosin; letter of intent; limit of detection; no observed adverse effect level