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Related Concept Videos

Survival Tree01:19

Survival Tree

Survival trees are a non-parametric method used in survival analysis to model the relationship between a set of covariates and the time until an event of interest occurs, often referred to as the "time-to-event" or "survival time." This method is particularly useful when dealing with censored data, where the event has not occurred for some individuals by the end of the study period, or when the exact time of the event is unknown.
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Pharmacovigilance01:19

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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Drug toxicity: Idiosyncratic Reactions01:16

Drug toxicity: Idiosyncratic Reactions

Idiosyncratic drug reactions represent abnormal chemical responses that vary significantly among individuals, ranging from extreme sensitivity to low doses to insensitivity to high doses. These reactions often occur due to the drug's covalent binding with serum proteins, forming a foreign hapten that triggers an immunotoxicological response. The variability in drug reactions has a strong pharmacogenetic foundation, with genetic differences crucial in how individuals metabolize drugs. For...
Mutagenicity and Carcinogenicity01:25

Mutagenicity and Carcinogenicity

Mutagenicity and carcinogenicity refer to the ability of drugs to cause genetic defects and induce cancer, respectively. The International Agency for Research on Cancer (IARC) classifies agents into four groups based on their carcinogenic potential. Group 1 agents are known human carcinogens; group 2A agents are probably carcinogenic to humans; group 3 agents lack data to support their role in carcinogenesis; and group 4 includes agents for which data support that they are not likely to be...
Drug Toxicity: Risk factors01:24

Drug Toxicity: Risk factors

Adverse Drug Reactions (ADRs) are potential complications that arise during pharmacotherapy, influenced by multiple risk factors. Age plays a significant role; both neonates and the elderly are at heightened risk due to their respective immature and diminished metabolic and elimination processes. Gender also impacts ADRs, with females experiencing a 1.5 to 1.7-fold greater risk than males, which may be linked to pharmacokinetic, pharmacodynamic, and hormonal differences. Notably, neonates, the...
Dosage Regimen: Individualization01:24

Dosage Regimen: Individualization

Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...

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Related Experiment Video

Updated: Jun 9, 2026

Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation
17:28

Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation

Published on: June 17, 2015

Plant natural variability may affect safety assessment data.

Rita Batista1, Margarida Oliveira

  • 1National Institute of Health, Av Padre Cruz, 1649-016 Lisboa, Portugal. rita.batista@insa.min-saude.pt

Regulatory Toxicology and Pharmacology : RTP
|September 1, 2010
PubMed
Summary

Analyzing genetically engineered (GE) maize safety requires careful consideration of natural plant variability. Pooling samples for omics analysis may mask crucial differences, impacting GE food safety assessments.

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Last Updated: Jun 9, 2026

Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation
17:28

Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation

Published on: June 17, 2015

Area of Science:

  • Food Science
  • Biotechnology
  • Toxicology

Background:

  • Genetic engineered (GE) foods undergo rigorous safety assessments before market introduction.
  • Novel profiling technologies aim to enhance the detection of unintended effects in GE food safety evaluations.
  • Current techniques face challenges in interpreting biological relevance and toxicological significance of observed differences.

Purpose of the Study:

  • To evaluate the sufficiency of 2D-gel electrophoresis of pooled samples for GE food safety assessment.
  • To investigate the impact of plant-to-plant variability on safety evaluations of genetically engineered maize.
  • To address limitations in interpreting omics data for toxicological significance.

Main Methods:

  • Performed 2D-gel electrophoresis on individual samples from five MON810 maize ears and five non-transgenic controls.
  • Conducted 2D-gel electrophoresis on pooled protein extracts from MON810 and control maize lines.
  • Compared protein profiles obtained from individual and pooled sample analyses.

Main Results:

  • Analysis of pooled samples alone was insufficient for adequate safety evaluation of MON810 maize.
  • Differences observed between individual plant samples highlighted the importance of accounting for natural variability.
  • Pooling obscured potentially significant variations relevant to safety assessment.

Conclusions:

  • Omics technologies require careful management of confounding factors, including natural plant variability.
  • Individual sample analysis is crucial for a comprehensive safety evaluation of genetically engineered organisms.
  • Understanding plant-to-plant variation is essential for accurate interpretation of omics data in food safety.