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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...
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.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
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Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

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

FDA Approved Drugs: Changes to Approved Drugs

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,...
Hazard Analysis and Critical Control Points (HACCP)01:30

Hazard Analysis and Critical Control Points (HACCP)

Hazard Analysis and Critical Control Points (HACCP) is a science-based, preventive system used globally to ensure food safety by identifying, evaluating, and controlling biological, chemical, and physical hazards throughout food production. Originally developed by NASA and the Pillsbury Company for astronaut food, HACCP is now a core component of the Codex Alimentarius.HACCP operates on prerequisite programs—such as Good Manufacturing Practices (GMPs), sanitation procedures, and supplier...

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Related Experiment Video

Updated: Jul 18, 2026

Solid Phase Synthesis of a Functionalized Bis-Peptide Using "Safety Catch" Methodology
11:42

Solid Phase Synthesis of a Functionalized Bis-Peptide Using "Safety Catch" Methodology

Published on: May 15, 2012

Safety evaluation of functional ingredients.

C L Kruger1, S W Mann

  • 1ENVIRON International Corporation, 4350 Fairfax Drive, Arlington, VA 22203, USA. ckruger@environcorp.com

Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association
|May 10, 2003
PubMed
Summary

Functional ingredients offer health benefits through physiological activity. Evaluating their safety involves understanding regulatory frameworks and conducting product-specific studies, including animal and clinical research.

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Area of Science:

  • Food Science and Technology
  • Nutritional Science
  • Toxicology

Background:

  • Functional ingredients are compounds designed to promote consumer health.
  • All foods possess inherent biological activity; the term 'functional' highlights intended health outcomes.
  • Functional ingredients integrate aspects of drugs, nutrients, and food additives.

Purpose of the Study:

  • To outline a framework for evaluating the safety of functional ingredients.
  • To emphasize the need for a comprehensive approach considering regulatory and ingredient-specific factors.

Main Methods:

  • Safety evaluation framework incorporates existing regulatory structures.
  • Product-specific studies include compositional analysis, toxicity assessments, and exposure evaluations.
  • Data generation involves animal studies, clinical/epidemiologic research, and assessment of potential interactions.

Main Results:

  • A structured approach to safety assessment is crucial for functional ingredients.
  • The evaluation process is adaptable and product-specific.
  • Consideration of interactions with food and drugs is essential.

Conclusions:

  • Functional ingredients require rigorous safety evaluations tailored to their unique properties.
  • Integrating regulatory knowledge with specific scientific data ensures consumer safety.
  • A holistic safety assessment framework supports the responsible development of functional ingredients.