ReviewMolecular therapy. Methods & clinical development2021
qPCR and qRT-PCR analysis: Regulatory points to consider when conducting biodistribution and vector shedding studies.
Review in Molecular therapy. Methods & clinical development, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 73 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
73 citing papers in PubMed.
- Article
- [Effect of inorganic pyrophosphatase PPA1 on proliferation and apoptosis of abnormal naive cells in acute B-lymphocytic leukemia].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2026Article
- Quantitative real-time PCR in the diagnosis of opportunistic infections in immunocompromised patients: Diagnostic performance, clinical utility, and future directions.Infectious diseases & immunity · 2026Review
- Article
- Staphylococcal Cassette ChromosomeAntibiotics (Basel, Switzerland) · 2026Article
- Article
- p75NTR Promotes Circadian-Driven Mineralization During Tooth Development via CK2/PER2 Pathway.Cell proliferation · 2026Article
- A Simple and Easy Method for RNA Extraction from the CyanobacteriumBio-protocol · 2026Article
- RT-qPCR and split-luciferase assays enable batch standardization and analysis of engineered virus-like particle transduction.Molecular therapy. Advances · 2026Article
- Quantification Revisited: What qPCR Efficiency Models Reveal About Data Analysis Integrity.International journal of molecular sciences · 2026Review
- Comparative Assessment of Different Nucleic Acid Templates for Use as Standards in the qPCR-Based Quantification of Virus Genomes.Veterinary medicine and science · 2026Article
- Overcoming inconsistent DNA extraction recovery across tissue types in qPCR assays supporting biodistribution studies.Bioanalysis · 2026Article
- Development of an RT-qPCR and a Next-Generation Sequencing approach to assess viral shedding of NDV-based SARS-CoV-2 variant vaccines.Microbiology spectrum · 2026Article
- Targeting QRICH1 suppresses epithelial-mesenchymal transition and tumor growth in liver cancer through the Connexin43/USP1 mediated Snail1 stabilization.International journal of biological sciences · 2026Article
- Herbal medicines against avian infectious bronchitis virus: shared host-directed and multi-stage antiviral pathways.Frontiers in veterinary science · 2026Review
- Diagnostic methods for protozoan diseases: a review focused on leishmaniasis, Chagas disease and malaria.Frontiers in microbiology · 2026Review
- A synergistic multi-omics approach: causal sepsis drivers identified in activated CD4Frontiers in cellular and infection microbiology · 2026Article
- Design of dual-effect molecules based on lysosome-targeting strategy: a mechanistic study on synergistic inhibition of ewing sarcoma and coronaviruses.Frontiers in chemistry · 2026Article
- Article
- The clinical significance of circulating microRNAs as biomarkers in lung cancer diagnosis and prognosis.Discover oncology · 2025Review
13 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Gene and cell therapy fields have experienced remarkable growth during the past decade. Demands for preclinical and clinical safety assessments of these cell and gene therapy test articles (TAs) have effectively increased the necessity for regulated biodistribution, vector shedding, gene expression, and/or pharmacokinetics bioanalysis studies. Guidance documents issued from numerous international regulatory authorities recommend the use of quantitative polymerase chain reaction (qPCR) and/or quantitative reverse transcriptase PCR (qRT-PCR) assays due to their highly sensitive and robust target-specific detection. However, only preclinical biodistribution assay sensitivity is specified in these documents. Criteria such as accuracy, precision, and repeatability are not yet defined. This guidance void has resulted in several conflicting institutional interpretations of essential parameters necessary for the development and validation of robust assays to support safety assessments of gene and cell therapy TAs. There is an urgent need for an ongoing discussion among bioanalytical scientists in this field to generate a "best practice" consensus around preclinical and clinical qPCR/qRT-PCR assay design. With regard to this need, we offer critical points to consider when developing, validating, running sample analysis, and reporting qPCR/qRT-PCR assays.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.