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Related Concept Videos

Proteomics01:33

Proteomics

7.5K
A proteome is the entire set of proteins that a cell type produces. We can study proteomes using the knowledge of genomes because genes code for mRNAs, and the mRNAs encode proteins. Although mRNA analysis is a step in the right direction, not all mRNAs are translated into proteins.
Proteomics is the study of proteomes' function. It involves the large-scale systematic study of the proteome to denote the protein complement expressed by a genome. Scientist Mark Wilkins coined the term...
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Regulation of Expression at Multiple Steps01:23

Regulation of Expression at Multiple Steps

1.4K
The gene expression in cells is regulated at different stages: (i) transcription, (ii) RNA processing, (iii) RNA localization, and (iv) translation. Transcriptional regulation is mediated by regulatory proteins such as transcription factors, activators, or repressors—these control gene expression by initiating or inhibiting the transcription of genes. Once a precursor or pre-mRNA is produced, it undergoes post-transcriptional modification, including 5' capping, splicing, and the...
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Ribosome Profiling02:24

Ribosome Profiling

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Ribosome profiling or ribo-sequencing is a deep sequencing technique that produces a snapshot of active translation in a cell. It selectively sequences the mRNAs protected by ribosomes to get an insight into a cell’s translation landscape at any given point in time.
Applications of ribosome profiling
Ribosome profiling has many applications, including in vivo monitoring of translation inside a particular organ or tissue type and quantifying new protein synthesis levels.
The technique...
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Related Experiment Video

Updated: May 5, 2026

Deep Proteome Profiling by Isobaric Labeling, Extensive Liquid Chromatography, Mass Spectrometry, and Software-assisted Quantification
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Proteomics quality and standard: from a regulatory perspective.

Qiang Gu1, Li-Rong Yu1

  • 1Division of Systems Biology, National Center for Toxicological Research, Food and Drug Administration, USA.

Journal of Proteomics
|December 10, 2013
PubMed
Summary

Proteomics data quality guidelines are needed for regulatory submissions. Developing a framework will ensure reliable data for agencies like the U.S. Food and Drug Administration (FDA) in making critical decisions.

Keywords:
Biomarker qualificationMass spectrometryProteomicsQuality controlRegulatory decisionStandards

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Area of Science:

  • Proteomics
  • Biomarker Discovery
  • Regulatory Science

Background:

  • Proteomics is a rapidly growing field focused on large-scale protein analysis.
  • Increasingly, proteomics data is submitted to regulatory agencies like the U.S. Food and Drug Administration (FDA).
  • Current lack of established guidelines for proteomics data generation and quality assessment poses challenges for regulatory review.

Purpose of the Study:

  • To highlight the need for standardized guidelines in proteomics data submission.
  • To initiate discussion on developing a framework for quality control of proteomics data.
  • To prepare regulatory agencies, such as the FDA, for evaluating proteomics data.

Main Methods:

  • Commentary and discussion-based approach.
  • Analysis of current practices and future needs in regulatory proteomics.
  • Identification of key areas for guideline development.

Main Results:

  • A significant gap exists in current regulatory frameworks for handling proteomics data.
  • There is a clear need for robust quality control standards for proteomics data.
  • A proactive approach is required to develop guidelines for data generation and assessment.

Conclusions:

  • Establishing clear guidelines for proteomics data is crucial for regulatory decision-making.
  • A collaborative framework will enhance the reliability and utility of proteomics data in regulatory science.
  • Proactive development of standards will enable agencies like the FDA to effectively utilize proteomics data for product approval and safety.