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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...
Drug Control Governance: Regulatory Bodies and Their Impact01:03

Drug Control Governance: Regulatory Bodies and Their Impact

Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with a...
Investigation of Disease Outbreaks01:23

Investigation of Disease Outbreaks

Multistate foodborne outbreaks pose significant public health risks and require meticulous investigation to identify sources and implement control measures. The Centers for Disease Control and Prevention (CDC) utilizes a dynamic seven-step process for these investigations, integrating data from laboratories, interviews, and environmental assessments to protect public health.Outbreak Detection: The detection of multistate outbreaks typically begins with PulseNet, the CDC's national laboratory...
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).
Preclinical Development: Overview01:28

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...

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Related Experiment Video

Updated: May 28, 2026

Analysis of Organochlorine Pesticides in a Soil Sample by a Modified QuEChERS Approach Using Ammonium Formate
04:17

Analysis of Organochlorine Pesticides in a Soil Sample by a Modified QuEChERS Approach Using Ammonium Formate

Published on: January 20, 2023

Opinion paper: Quo vadis - EFSA?

G Reid1

  • 1Lawson Health Research Institute, Canadian Research & Development Centre for Probiotics, London N6A 4V2 Ontario, Canada. gregor@uwo.ca

Beneficial Microbes
|October 12, 2011
PubMed
Summary

Probiotics show promise for infectious disease management, but regulatory bodies like the European Food Safety Authority (EFSA) are hindering their validation. This challenges established scientific approaches to health.

Area of Science:

  • Microbiology
  • Infectious Diseases
  • Regulatory Science

Background:

  • Infectious diseases and antimicrobial resistance pose significant global health threats.
  • Current treatment options are diminishing, necessitating novel therapeutic strategies.
  • Probiotics represent a validated approach to infectious disease management.

Purpose of the Study:

  • To critique the European Food Safety Authority's (EFSA) panel and its handling of probiotic research.
  • To highlight the scientific community's concerns regarding EFSA's rejection of evidence-based probiotic health claims.
  • To advocate for a science-driven approach to evaluating probiotics for infectious disease management.

Main Methods:

  • Review of EFSA's recent decisions and scientific assessments regarding probiotics.

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Using Tg(Vtg1:mcherry) Zebrafish Embryos to Test the Estrogenic Effects of Endocrine Disrupting Compounds
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Using Tg(Vtg1:mcherry) Zebrafish Embryos to Test the Estrogenic Effects of Endocrine Disrupting Compounds

Published on: August 8, 2020

High Content Screening Analysis to Evaluate the Toxicological Effects of Harmful and Potentially Harmful Constituents (HPHC)
11:38

High Content Screening Analysis to Evaluate the Toxicological Effects of Harmful and Potentially Harmful Constituents (HPHC)

Published on: May 10, 2016

Related Experiment Videos

Last Updated: May 28, 2026

Analysis of Organochlorine Pesticides in a Soil Sample by a Modified QuEChERS Approach Using Ammonium Formate
04:17

Analysis of Organochlorine Pesticides in a Soil Sample by a Modified QuEChERS Approach Using Ammonium Formate

Published on: January 20, 2023

Using Tg(Vtg1:mcherry) Zebrafish Embryos to Test the Estrogenic Effects of Endocrine Disrupting Compounds
12:02

Using Tg(Vtg1:mcherry) Zebrafish Embryos to Test the Estrogenic Effects of Endocrine Disrupting Compounds

Published on: August 8, 2020

High Content Screening Analysis to Evaluate the Toxicological Effects of Harmful and Potentially Harmful Constituents (HPHC)
11:38

High Content Screening Analysis to Evaluate the Toxicological Effects of Harmful and Potentially Harmful Constituents (HPHC)

Published on: May 10, 2016

  • Analysis of peer-reviewed studies supporting the efficacy of probiotics.
  • Critique of bureaucratic processes that impede scientific validation.
  • Main Results:

    • EFSA's panel has disregarded peer-reviewed research and scientific evidence.
    • The rejection of a vaginal health claim exemplifies flawed regulatory practices.
    • EFSA's actions undermine the potential of probiotics in healthcare.

    Conclusions:

    • EFSA's current approach to probiotic evaluation is scientifically unsound.
    • There is an urgent need for regulatory bodies to embrace evidence-based science.
    • Probiotics warrant further investigation and validation for managing infectious diseases.