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Related Concept Videos

Drug Regulation01:25

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
Difference from Background: Limit of Detection01:05

Difference from Background: Limit of Detection

The limit of detection (LOD) is the smallest amount of analyte that can be distinguished from the background noise. The LOD value corresponds to the concentration at which the analyte signal is three times larger than the standard deviation of the blank signal. Below this value, the analyte signal cannot be differentiated from the background noise. It is calculated by dividing the calibration slope by 3 times the standard deviation of the blank signals.
The LOD indicates the presence or absence...
Drug Concentrations: Measurements01:23

Drug Concentrations: Measurements

Drug concentration is the quantity of a drug present in a biological sample. Measuring drug amounts in biological samples allows the clinician to understand how a drug is absorbed, distributed, metabolized, and excreted. Samples can be obtained through invasive or non-invasive methods. Invasive techniques involve surgical or parenteral interventions to gather blood, cerebrospinal fluid, or tissue biopsy. Conversely, non-invasive approaches provide samples like urine, feces, and saliva.
Plasma —...
Bioavailability Study Design: Absolute Versus Relative Bioavailability01:27

Bioavailability Study Design: Absolute Versus Relative Bioavailability

Bioavailability is a crucial pharmacokinetic parameter that quantifies the proportion of an administered drug that reaches the systemic circulation and is available for therapeutic action. Regulatory agencies mandate the assessment of bioavailability, typically measured as the area under the drug plasma concentration-versus-time curve (AUC), to ensure the efficacy and safety of pharmaceutical products. These evaluations are categorized as absolute and relative bioavailability studies.Absolute...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Regulation of Food Intake01:30

Regulation of Food Intake

Short-term regulation of food intake primarily involves neural signals from the gastrointestinal (GI) tract, blood nutrient levels, and GI tract hormones. Communication between the gut and brain via vagal nerve fibers plays a significant role in evaluating the contents of the gut. Clinical studies have shown that protein ingestion produces a more prolonged response in these nerve fibers compared to an equivalent amount of glucose. Additionally, the activation of stretch receptors caused by GI...

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Related Experiment Videos

Highest Observed Intake: definition, regulatory uses and provisional values.

John Hathcock1, Wantanee Kriengsinyos

  • 1Council for Responsible Nutrition, 1828 L St., NW, Suite 510, WA 20036, USA. jhathcock@crnusa.org

Regulatory Toxicology and Pharmacology : RTP
|August 2, 2011
PubMed
Summary

The Highest Observed Intake (HOI) is proposed as a new risk assessment value for nutrients lacking established adverse effects, complementing the Tolerable Upper Intake Level (UL). This approach ensures comprehensive nutrient safety evaluations, addressing limitations in current risk assessment methods.

Related Experiment Videos

Area of Science:

  • Nutritional science
  • Toxicology
  • Public health policy

Background:

  • The Tolerable Upper Intake Level (UL) is the standard risk assessment method for nutrients.
  • A key limitation of the UL is its inability to assess nutrients without known adverse effects.
  • This gap necessitates an alternative approach for comprehensive risk assessment.

Purpose of the Study:

  • To introduce and define the Highest Observed Intake (HOI) as a complementary risk assessment value.
  • To address the limitations of the UL method for nutrients lacking established adverse effects.
  • To advocate for the integration of HOI into nutrient risk assessment frameworks.

Main Methods:

  • Literature review and analysis of existing risk assessment methodologies.
  • Definition and conceptualization of the Highest Observed Intake (HOI).
  • Examination of case studies, such as vitamin B12, to illustrate the need for HOI.

Main Results:

  • The HOI is defined as the highest intake level with sufficient data to demonstrate the absence of adverse effects with acceptable confidence.
  • The HOI concept, endorsed by FAO and WHO, provides a method for assessing nutrients without known adverse effects.
  • Tentative HOI values were identified for several vitamins and non-essential nutrients, highlighting regulatory utility.

Conclusions:

  • A complete nutrient risk assessment requires both UL for substances with known adverse effects and HOI for those without.
  • The HOI concept addresses critical gaps in current risk assessment, preventing unjustified regulatory actions.
  • Broad acceptance and use of HOI values depend on endorsement by authoritative bodies.