Detection, Monitoring, and Mitigation of Drug-Induced Nephrotoxicity : A Pragmatic Approach
© 2023. The Author(s)..
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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:58 |
|---|---|
| Enthalten in: |
Therapeutic innovation & regulatory science - 58(2024), 2 vom: 18. Feb., Seite 286-302 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Antognini, Nicola [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Acute kidney injury |
|---|
| Anmerkungen: |
Date Completed 09.02.2024 Date Revised 10.02.2024 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1007/s43441-023-00599-x |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM366014838 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM366014838 | ||
| 003 | DE-627 | ||
| 005 | 20240210233002.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231227s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1007/s43441-023-00599-x |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1287.xml |
| 035 | |a (DE-627)NLM366014838 | ||
| 035 | |a (NLM)38110788 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Antognini, Nicola |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Detection, Monitoring, and Mitigation of Drug-Induced Nephrotoxicity |b A Pragmatic Approach |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 09.02.2024 | ||
| 500 | |a Date Revised 10.02.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023. The Author(s). | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Review | |
| 650 | 4 | |a Acute kidney injury | |
| 650 | 4 | |a Biomarkers | |
| 650 | 4 | |a Chronic kidney disease | |
| 650 | 4 | |a Creatinine | |
| 650 | 4 | |a Drug development | |
| 650 | 4 | |a Drug-induced nephrotoxicity | |
| 650 | 4 | |a Glomerular filtration rate | |
| 650 | 4 | |a Monitoring | |
| 650 | 4 | |a Nephrotoxicity | |
| 650 | 7 | |a Biomarkers |2 NLM | |
| 700 | 1 | |a Portman, Ronald |e verfasserin |4 aut | |
| 700 | 1 | |a Dong, Victor |e verfasserin |4 aut | |
| 700 | 1 | |a Webb, Nicholas J |e verfasserin |4 aut | |
| 700 | 1 | |a Chand, Deepa H |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Therapeutic innovation & regulatory science |d 2013 |g 58(2024), 2 vom: 18. Feb., Seite 286-302 |w (DE-627)NLM243752342 |x 2168-4804 |7 nnns |
| 773 | 1 | 8 | |g volume:58 |g year:2024 |g number:2 |g day:18 |g month:02 |g pages:286-302 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1007/s43441-023-00599-x |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 58 |j 2024 |e 2 |b 18 |c 02 |h 286-302 | ||