Detection, Monitoring, and Mitigation of Drug-Induced Nephrotoxicity: A Pragmatic Approach.
Ther Innov Regul Sci
; 58(2): 286-302, 2024 03.
Article
en En
| MEDLINE
| ID: mdl-38110788
ABSTRACT
The kidneys play a pivotal role in elimination of most drugs; therefore, a comprehensive understanding of renal physiology and pathology is important for those involved in drug development. High filtration capacity and metabolic activity make the kidneys vulnerable to drug-induced nephrotoxicity (DIN). Acute DIN may manifest on a background of renal impairment that has resulted from underlying disease, previously administered nephrotoxic medications, congenital renal abnormalities, or the natural aging process. The ability of the kidneys to compensate for DIN depends on the degree of pre-insult renal function. Therefore, it can be difficult to identify. The discovery and development of novel biomarkers that can diagnose kidney damage earlier and more accurately than current clinical measures and may be effective in detecting DIN. The goal of this manuscript is to provide a pragmatic and evidence-based supportive guidance for the early identification and management of DIN during the drug development process for clinical trial participants of all ages. The overall objective is to minimize the impact of DIN on kidney function and to collect renal safety data enabling risk analysis and mitigation.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Contexto en salud:
1_ASSA2030
Problema de salud:
1_doencas_nao_transmissiveis
Asunto principal:
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos
/
Lesión Renal Aguda
Límite:
Humans
Idioma:
En
Revista:
Ther Innov Regul Sci
Año:
2024
Tipo del documento:
Article
País de afiliación:
Suiza