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Development and Validation of a Quantitative LC-MS/MS Method for Measuring CYP4V2 Enzyme Activity via 12-Hydroxylauric Acid in rAAV-hCYP4V2 Gene Therapy Products.

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Title: Development and Validation of a Quantitative LC-MS/MS Method for Measuring CYP4V2 Enzyme Activity via 12-Hydroxylauric Acid in rAAV-hCYP4V2 Gene Therapy Products.
Authors: Ren G; National Institutes for Food and Drug Control, Beijing 100050, China.; State Key Laboratory of Drug Regulatory Science, Beijing 100050, China.; School of Life and Health Sciences, Hubei University of Technology, Wuhan 430068, China., Qin X; National Institutes for Food and Drug Control, Beijing 100050, China.; State Key Laboratory of Drug Regulatory Science, Beijing 100050, China., Li Y; National Institutes for Food and Drug Control, Beijing 100050, China.; State Key Laboratory of Drug Regulatory Science, Beijing 100050, China., Fan W; National Institutes for Food and Drug Control, Beijing 100050, China.; State Key Laboratory of Drug Regulatory Science, Beijing 100050, China., Luo W; Shanghai Vitalgen BioPharma Co., Ltd., Shanghai 201210, China., Cao Y; Shanghai Vitalgen BioPharma Co., Ltd., Shanghai 201210, China., Wang Y; School of Life and Health Sciences, Hubei University of Technology, Wuhan 430068, China., Zhou Y; National Institutes for Food and Drug Control, Beijing 100050, China.; State Key Laboratory of Drug Regulatory Science, Beijing 100050, China., Liang C; National Institutes for Food and Drug Control, Beijing 100050, China.; State Key Laboratory of Drug Regulatory Science, Beijing 100050, China.
Source: Molecules (Basel, Switzerland) [Molecules] 2026 Apr 24; Vol. 31 (9). Date of Electronic Publication: 2026 Apr 24.
Publication Type: Journal Article
Journal Info: Publisher: MDPI Country of Publication: Switzerland NLM ID: 100964009 Publication Model: Electronic Cited Medium: Internet ISSN: 1420-3049 (Electronic) Linking ISSN: 14203049 NLM ISO Abbreviation: Molecules Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Development and Validation of a Quantitative LC-MS/MS Method for Measuring CYP4V2 Enzyme Activity via 12-Hydroxylauric Acid in rAAV-hCYP4V2 Gene Therapy Products.
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  Data: <searchLink fieldCode="AU" term="%22Ren+G%22">Ren G</searchLink>; National Institutes for Food and Drug Control, Beijing 100050, China.; State Key Laboratory of Drug Regulatory Science, Beijing 100050, China.; School of Life and Health Sciences, Hubei University of Technology, Wuhan 430068, China.<br /><searchLink fieldCode="AU" term="%22Qin+X%22">Qin X</searchLink>; National Institutes for Food and Drug Control, Beijing 100050, China.; State Key Laboratory of Drug Regulatory Science, Beijing 100050, China.<br /><searchLink fieldCode="AU" term="%22Li+Y%22">Li Y</searchLink>; National Institutes for Food and Drug Control, Beijing 100050, China.; State Key Laboratory of Drug Regulatory Science, Beijing 100050, China.<br /><searchLink fieldCode="AU" term="%22Fan+W%22">Fan W</searchLink>; National Institutes for Food and Drug Control, Beijing 100050, China.; State Key Laboratory of Drug Regulatory Science, Beijing 100050, China.<br /><searchLink fieldCode="AU" term="%22Luo+W%22">Luo W</searchLink>; Shanghai Vitalgen BioPharma Co., Ltd., Shanghai 201210, China.<br /><searchLink fieldCode="AU" term="%22Cao+Y%22">Cao Y</searchLink>; Shanghai Vitalgen BioPharma Co., Ltd., Shanghai 201210, China.<br /><searchLink fieldCode="AU" term="%22Wang+Y%22">Wang Y</searchLink>; School of Life and Health Sciences, Hubei University of Technology, Wuhan 430068, China.<br /><searchLink fieldCode="AU" term="%22Zhou+Y%22">Zhou Y</searchLink>; National Institutes for Food and Drug Control, Beijing 100050, China.; State Key Laboratory of Drug Regulatory Science, Beijing 100050, China.<br /><searchLink fieldCode="AU" term="%22Liang+C%22">Liang C</searchLink>; National Institutes for Food and Drug Control, Beijing 100050, China.; State Key Laboratory of Drug Regulatory Science, Beijing 100050, China.
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  Data: <searchLink fieldCode="JN" term="%22100964009%22">Molecules (Basel, Switzerland)</searchLink> [Molecules] 2026 Apr 24; Vol. 31 (9). <i>Date of Electronic Publication: </i>2026 Apr 24.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22MDPI%22">MDPI </searchLink><i>Country of Publication: </i>Switzerland <i>NLM ID: </i>100964009 <i>Publication Model: </i>Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1420-3049 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2214203049%22">14203049 </searchLink><i>NLM ISO Abbreviation: </i>Molecules <i>Subsets: </i>MEDLINE
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        Value: 10.3390/molecules31091417
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        Text: English
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      – TitleFull: Development and Validation of a Quantitative LC-MS/MS Method for Measuring CYP4V2 Enzyme Activity via 12-Hydroxylauric Acid in rAAV-hCYP4V2 Gene Therapy Products.
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            NameFull: Ren G
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            NameFull: Qin X
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            – D: 24
              M: 04
              Text: 2026 Apr 24
              Type: published
              Y: 2026
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