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Related Concept Videos

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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...
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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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FDA Approved Drugs: Changes to Approved Drugs01:26

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Bioavailability Enhancement: Drug Stability Enhancement and GI Retention01:05

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Improving a drug's stability in the gastrointestinal (GI) tract is paramount for enhancing its bioavailability and therapeutic effectiveness. Various strategies are employed to protect the drug from the harsh gastric milieu and to ensure its release and absorption at the desired site within the GI tract.Polymer coatings are one such method used to shield drugs from the stomach's acidic environment. By preventing premature drug release, these coatings improve the bioavailability of unstable...
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Pharmaceutical Poisoning: Potential Scenarios01:26

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Pharmaceutical poisoning can occur through various channels, impacting an estimated 2 million hospitalized patients in the U.S. annually with serious adverse drug responses. These scenarios encompass both therapeutic uses, such as drug toxicity, where even standard dosages can lead to severe central nervous system depression, and non-therapeutic exposures, including accidental ingestion by children, and environmental and occupational exposures.Unintentional poisonings often involve exploratory...
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Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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Demonstration of the Sequence Alignment to Predict Across Species Susceptibility Tool for Rapid Assessment of Protein Conservation
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Advances in assessing ingredient safety.

Michael L Dourson1, Raymond G York2

  • 1Toxicology Excellence for Risk Assessment (TERA), 2300 Montana Avenue, Suite 409, Cincinnati, OH 45211, USA.

Regulatory Toxicology and Pharmacology : RTP
|July 19, 2016
PubMed
Summary
This summary is machine-generated.

Food ingredient safety in the 21st century combines traditional "safe" dose concepts with advanced methods like Benchmark Dose (BMD) modeling. Emerging toxicology research promises further refinement of these crucial food safety risk assessment techniques.

Keywords:
Acceptable daily intakeBenchmark doseCritical effectIngredient safetyReference doseRisk assessmentUncertainty factor

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Area of Science:

  • Food safety assessment
  • Toxicology
  • Risk analysis

Background:

  • Traditional methods for food ingredient safety, like the "safe" dose concept, offer imprecision.
  • Contemporary methods are needed to enhance the accuracy of safety assessments.

Purpose of the Study:

  • To describe traditional, contemporary, and emerging methods for 21st-century food ingredient safety assessment.
  • To highlight advancements in toxicological risk analysis.

Main Methods:

  • Review of traditional safety assessment concepts (e.g., "safe" dose).
  • Description of contemporary methods: Benchmark Dose (BMD), Chemical Specific Adjustment Factors (CSAF), physiologically-based pharmacokinetic models, and biologically-informed dose-response modeling.
  • Discussion of emerging research in toxicology (Toxicology 21).

Main Results:

  • The study outlines a multifaceted approach to food safety, integrating established and novel methodologies.
  • It highlights the evolution from imprecise traditional methods to more sophisticated quantitative risk assessment tools.
  • Emerging research is poised to further refine and innovate these safety evaluation techniques.

Conclusions:

  • 21st-century food ingredient safety relies on a blend of traditional and advanced toxicological methods.
  • Benchmark Dose (BMD) and related modeling approaches represent significant progress in risk assessment.
  • Ongoing research in toxicology is expected to yield even more precise and reliable safety evaluation strategies.