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Related Concept Videos

Mutations01:39

Mutations

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Overview
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Mutations01:35

Mutations

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Mutations are changes in the sequence of DNA. These changes can occur spontaneously or they can be induced by exposure to environmental factors. Mutations can be characterized in a number of different ways: whether and how they alter the amino acid sequence of the protein, whether they occur over a small or large area of DNA, and whether they occur in somatic cells or germline cells.
Chromosomal Alterations Are Large-Scale Mutations
While point mutations are changes in a single nucleotide in...
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Viral Mutations00:36

Viral Mutations

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A mutation is a change in the sequence of bases of DNA or RNA in a genome. Some mutations occur during replication of the genome due to errors made by the polymerase enzymes that replicate DNA or RNA. Unlike DNA polymerase, RNA polymerase is prone to errors because it is not capable of “proofreading” its work. Viruses with RNA-based genomes, like HIV, therefore accrue mutations faster than viruses with DNA-based genomes. Because mutation and recombination provide the raw material...
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EDTA: Auxiliary Complexing Reagents01:26

EDTA: Auxiliary Complexing Reagents

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EDTA titrations are usually carried out in highly basic conditions, where the fully deprotonated form of EDTA, Y4−, actively complexes with the free metal ions in the solution. Several metal ions precipitate as hydrous oxide (hydroxides, oxides, or oxyhydroxides) under these conditions, lowering the concentration of free metal ions in the solution. For this reason, auxiliary complexing agents or ligands such as ammonia, tartrate, citrate, or triethanolamine are used in EDTA titrations to...
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Mutation, Gene Flow, and Genetic Drift01:09

Mutation, Gene Flow, and Genetic Drift

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In a population that is not at Hardy-Weinberg equilibrium, the frequency of alleles changes over time. Therefore, any deviations from the five conditions of Hardy-Weinberg equilibrium can alter the genetic variation of a given population. Conditions that change the genetic variability of a population include mutations, natural selection, non-random mating, gene flow, and genetic drift (small population size).
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Point and Frameshift Mutations01:30

Point and Frameshift Mutations

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Point mutations are genetic alterations involving the change of a single nucleotide base pair in DNA. Depending on how the alteration affects protein synthesis, they can lead to various consequences.Point mutations fall into the following types:Silent mutations occur when a nucleotide change does not alter the amino acid sequence due to the redundancy of the genetic code. For instance, changing ACC to ACA still encodes threonine, leaving the protein function unaffected. This occurs because...
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Deciphering the Structural Effects of Activating EGFR Somatic Mutations with Molecular Dynamics Simulation
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[Resolved Problems of EGFR Mutation Detection Reagent Registration Application].

Chuansong Wu1, Jie Huang2, Juanjuan An1

  • 1Center for Medical Devices Evaluation of CFDA, Beijing, 100044.

Zhongguo Yi Liao Qi Xie Za Zhi = Chinese Journal of Medical Instrumentation
|June 5, 2018
PubMed
Summary

This study addresses challenges in human Epidermal Growth Factor Receptor (EGFR) gene mutation detection reagent registration. It offers solutions to improve the approval process for these vital cancer therapy tools.

Keywords:
gene mutationhuman epidermal growth factor receptor

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Area of Science:

  • Molecular Biology
  • Oncology
  • Biotechnology

Background:

  • Cancer treatment increasingly relies on molecularly targeted therapies.
  • Detection reagents for specific gene mutations, like human Epidermal Growth Factor Receptor (EGFR), are crucial for personalized medicine.
  • Rapid development in this field presents regulatory challenges.

Purpose of the Study:

  • To analyze common problems encountered during the registration of human EGFR gene mutation detection reagents.
  • To propose solutions for overcoming these regulatory hurdles.
  • To provide guidance for personnel involved in product registration.

Main Methods:

  • Review of past registration application data for EGFR mutation detection reagents.
  • Analysis of recurring issues and challenges.
  • Development of a proposed solution framework.

Main Results:

  • Identification of key obstacles in the registration process.
  • A structured approach to address identified problems.
  • Recommendations for streamlining regulatory submissions.

Conclusions:

  • Addressing common registration issues can accelerate the availability of essential cancer diagnostic tools.
  • Standardized solutions can improve the efficiency of regulatory review for gene mutation detection reagents.
  • This work aims to facilitate the successful registration of EGFR mutation detection products.