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Toxicity tests in animals are grounded on two main assumptions: first, the effects observed in laboratory animals can be extrapolated to humans, especially when adjusted for body surface area; second, high-dose exposure in animals is essential to identify potential human hazards from lower doses. This is based on the quantal dose-response concept, which faces the challenge of extrapolating results from relatively few test animals to much larger human populations. For example, a 0.01% incidence...
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Advances in genomics have profoundly influenced drug discovery by increasing both the speed and accuracy of pharmaceutical development. Pharmacogenomics, which examines how genetic variation influences drug response, facilitates the identification of novel therapeutic targets and enables patient stratification for personalized treatment. These strategies contribute to improved drug efficacy, minimized adverse effects, and more efficient clinical trial design.Mapping genetic differences...
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Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood or body tissues to tailor drug therapy effectively. This monitoring is critical for managing drugs with narrow therapeutic indices like digoxin and phenytoin, ensuring they are both safe and effective. For instance, monitoring theophylline levels in asthma patients involves precision and sensitivity to adjust doses according to individual responses to therapy, ensuring efficacy and...
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Studies that assess how a drug is absorbed, distributed, metabolized, and excreted (ADME) at toxic doses are termed toxicokinetics. Understanding toxicokinetics helps predict adverse drug reactions (ADRs) and manage toxicity in humans.Toxicokinetics differs from pharmacokinetics mainly in the dose levels studied, with toxicokinetics focusing on higher toxic doses. The kinetics at these levels can be non-linear due to altered physiological processes. Toxicodynamics examines the relationship...
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Cytochrome P450 (CYP450) enzymes are a superfamily of heme-containing monooxygenases that play a pivotal role in Phase I drug metabolism by catalyzing oxidation and reduction reactions.These enzymes transform lipophilic xenobiotics into more hydrophilic metabolites, facilitating subsequent Phase II conjugation and eventual excretion. The CYP450 family is classified into families (e.g., CYP1–CYP3) and subfamilies (e.g., CYP2A, CYP2C), based on amino acid sequence homology.CYP450...
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Precision Medicine in Toxicology.

Daniel A Schwarz1, M P George2, Martin H Bluth3

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|November 16, 2016
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Precision medicine in toxicology uses genetic understanding of liver metabolism for drugs. Knowing drug interactions and genetic variations improves patient treatment and safety.

Keywords:
CytochromeMetabolismPharmacogeneticsPharmacogenomicsPrecision medicineToxicology

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Area of Science:

  • Pharmacology and Toxicology
  • Genetics and Genomics

Background:

  • Precision medicine is increasingly vital in toxicology, particularly concerning drug metabolism.
  • Understanding hepatic metabolism, including Phase I (oxidation/reduction) and Phase II (conjugation) pathways, is key.
  • Cytochrome P450 enzymes play a central role in drug metabolism.

Purpose of the Study:

  • To review the fundamentals of hepatic metabolism and its genetic basis.
  • To explore common substrates, inducers, and inhibitors of cytochrome P450 enzymes.
  • To detail the metabolism of frequently used opioids and highlight the role of genetic variants.

Main Methods:

  • Literature review of hepatic metabolism, cytochrome P450 enzymes, and genetic variants.
  • Analysis of common drug substrates, inducers, and inhibitors.
  • Detailed examination of opioid metabolism pathways.

Main Results:

  • Hepatic metabolism, governed by genetic factors, significantly impacts drug toxicology.
  • Cytochrome P450 enzymes exhibit considerable genetic variability affecting drug response.
  • Opioid metabolism is influenced by specific enzyme variants and drug interactions.

Conclusions:

  • Genetic variations in drug-metabolizing enzymes are crucial for precision toxicology.
  • Understanding enzyme inducers, inhibitors, and genetic polymorphisms is essential for personalized medicine.
  • Applied precision medicine in toxicology enhances patient care through tailored drug therapy.