Metabolite Identification in the Preclinical and Clinical Phase of Drug Development
Copyright© Bentham Science Publishers; For any queries, please email at epubbenthamscience.net..
Metabolite identification plays a critical role in the phases during drug development. Drug metabolites can contribute to efficacy, toxicity, and drug-drug interaction. Thus, the correct identification of metabolites is essential to understand the behavior of drugs in humans. Drug administration authorities (e.g., FDA, EMA, and NMPA) emphasize evaluating the safety of human metabolites with exposure higher than 10% of the total drugrelated components. Many previous reviews have summarized the various methods, tools, and strategies for the appropriate and comprehensive identification of metabolites. In this review, we focus on summarizing the importance of identifying metabolites in the preclinical and clinical phases of drug development. Summarized scenarios include the role of metabolites in pharmacokinetics/pharmacodynamics (PK/PD) analysis, disproportional exposure of metabolites that contribute to drug toxicity, changes in metabolite exposure in renal-impaired patients, covalent tyrosine kinase inhibitors (anticancer drugs), and metabolite identification of drug candidates from natural medicines. This review is aimed to provide meaningful insight into the significant role of metabolite identification in drug development.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2021 |
|---|---|
| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:22 |
|---|---|
| Enthalten in: |
Current drug metabolism - 22(2021), 11 vom: 05., Seite 838-857 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Wu, Yali [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Covalent-binding drug |
|---|
| Anmerkungen: |
Date Completed 15.03.2022 Date Revised 15.03.2022 published: Print Citation Status MEDLINE |
|---|
| doi: |
10.2174/1389200222666211006104502 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM331610663 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM331610663 | ||
| 003 | DE-627 | ||
| 005 | 20231225213836.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2021 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.2174/1389200222666211006104502 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1105.xml |
| 035 | |a (DE-627)NLM331610663 | ||
| 035 | |a (NLM)34620061 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Wu, Yali |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Metabolite Identification in the Preclinical and Clinical Phase of Drug Development |
| 264 | 1 | |c 2021 | |
| 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 15.03.2022 | ||
| 500 | |a Date Revised 15.03.2022 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright© Bentham Science Publishers; For any queries, please email at epubbenthamscience.net. | ||
| 520 | |a Metabolite identification plays a critical role in the phases during drug development. Drug metabolites can contribute to efficacy, toxicity, and drug-drug interaction. Thus, the correct identification of metabolites is essential to understand the behavior of drugs in humans. Drug administration authorities (e.g., FDA, EMA, and NMPA) emphasize evaluating the safety of human metabolites with exposure higher than 10% of the total drugrelated components. Many previous reviews have summarized the various methods, tools, and strategies for the appropriate and comprehensive identification of metabolites. In this review, we focus on summarizing the importance of identifying metabolites in the preclinical and clinical phases of drug development. Summarized scenarios include the role of metabolites in pharmacokinetics/pharmacodynamics (PK/PD) analysis, disproportional exposure of metabolites that contribute to drug toxicity, changes in metabolite exposure in renal-impaired patients, covalent tyrosine kinase inhibitors (anticancer drugs), and metabolite identification of drug candidates from natural medicines. This review is aimed to provide meaningful insight into the significant role of metabolite identification in drug development | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Review | |
| 650 | 4 | |a Metabolite identification | |
| 650 | 4 | |a covalent-binding drug | |
| 650 | 4 | |a drug exposure | |
| 650 | 4 | |a drug safety | |
| 650 | 4 | |a drug toxicity | |
| 650 | 4 | |a natural medicines. | |
| 650 | 7 | |a Pharmaceutical Preparations |2 NLM | |
| 700 | 1 | |a Pan, Lulu |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Zhendong |e verfasserin |4 aut | |
| 700 | 1 | |a Zheng, Yuandong |e verfasserin |4 aut | |
| 700 | 1 | |a Diao, Xingxing |e verfasserin |4 aut | |
| 700 | 1 | |a Zhong, Dafang |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Current drug metabolism |d 2000 |g 22(2021), 11 vom: 05., Seite 838-857 |w (DE-627)NLM113669038 |x 1875-5453 |7 nnns |
| 773 | 1 | 8 | |g volume:22 |g year:2021 |g number:11 |g day:05 |g pages:838-857 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.2174/1389200222666211006104502 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 22 |j 2021 |e 11 |b 05 |h 838-857 | ||