Technical Considerations of Pharmacokinetic Assays for LNP-mRNA Drug Products by RT-qPCR
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F86652036%3A_____%2F25%3A00639450" target="_blank" >RIV/86652036:_____/25:00639450 - isvavai.cz</a>
Result on the web
<a href="https://link.springer.com/article/10.1208/s12248-025-01122-w" target="_blank" >https://link.springer.com/article/10.1208/s12248-025-01122-w</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1208/s12248-025-01122-w" target="_blank" >10.1208/s12248-025-01122-w</a>
Alternative languages
Result language
angličtina
Original language name
Technical Considerations of Pharmacokinetic Assays for LNP-mRNA Drug Products by RT-qPCR
Original language description
Lipid nanoparticle-messenger RNA (LNP-mRNA) drug products are a growing class of drug modalities. The unique composition of these drug products requires multiple measurements to account for the different components of these drug modalities. Pharmacokinetic (PK) measurements include measurement of the encapsulated mRNA and components of the LNP in circulation to understand the effectiveness of the therapeutic mRNA. The PK measurements can utilize many different platforms including PCR. Current regulatory guidance documents for bioanalytical method validation are specific to ligand binding and chromatographic assay methods and difficult to interpret for use with molecular workflows. The purpose of this paper is to provide information on considerations for validation of regulated reverse transcription quantitative PCR (RT-qPCR) assays that are used to support the pharmacokinetic analysis of LNP-mRNA drug products.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30104 - Pharmacology and pharmacy
Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2025
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
AAPS Journal
ISSN
1550-7416
e-ISSN
1550-7416
Volume of the periodical
27
Issue of the periodical within the volume
6
Country of publishing house
US - UNITED STATES
Number of pages
18
Pages from-to
144
UT code for WoS article
001575270000001
EID of the result in the Scopus database
2-s2.0-10501676485