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Related Concept Videos

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...
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).
Pharmaceutical Poisoning: Potential Scenarios01:26

Pharmaceutical Poisoning: Potential Scenarios

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...
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...
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...
Pharmacodynamics: Overview and Principles01:21

Pharmacodynamics: Overview and Principles

Pharmacodynamics is a scientific field that delves into drugs' intricate biochemical, cellular, and physiological effects on the human body. The study of pharmacodynamics helps us understand how drugs interact with the body and elicit various responses.
Most drugs' effects result from their interactions with drug receptors or targets within the body. These interactions trigger specific responses at the cellular or systemic level. Drug receptors can be found on the surfaces of cells or within...

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Related Experiment Video

Updated: May 11, 2026

Implementation of In Vitro Drug Resistance Assays: Maximizing the Potential for Uncovering Clinically Relevant Resistance Mechanisms
08:46

Implementation of In Vitro Drug Resistance Assays: Maximizing the Potential for Uncovering Clinically Relevant Resistance Mechanisms

Published on: December 9, 2015

Implementing ecopharmacovigilance in practice: challenges and potential opportunities.

Gisela Holm1, Jason R Snape, Richard Murray-Smith

  • 1AstraZeneca, Safety Health and Environment, 151 85 Södertälje, Sweden. Gisela.holm@astrazeneca.com

Drug Safety
|April 27, 2013
PubMed
Summary

Ecopharmacovigilance (EPV) compares to pharmacovigilance (PV), highlighting challenges in environmental signal detection. Practical measures are proposed to manage pharmaceuticals in the environment (PIE) risks throughout a drug’s lifecycle.

Related Experiment Videos

Last Updated: May 11, 2026

Implementation of In Vitro Drug Resistance Assays: Maximizing the Potential for Uncovering Clinically Relevant Resistance Mechanisms
08:46

Implementation of In Vitro Drug Resistance Assays: Maximizing the Potential for Uncovering Clinically Relevant Resistance Mechanisms

Published on: December 9, 2015

Area of Science:

  • Environmental Science
  • Pharmacology
  • Ecotoxicology

Background:

  • Ecopharmacovigilance (EPV) is an emerging field with practical implementation challenges.
  • Comparing EPV to traditional pharmacovigilance (PV) reveals key similarities and differences.
  • Environmental signal detection and establishing causality present significant hurdles for EPV.

Purpose of the Study:

  • To compare pharmacovigilance (PV) and ecopharmacovigilance (EPV).
  • To identify practical measures for assessing and managing environmental risks of pharmaceuticals.
  • To ensure scientific and ecological relevance of risk assessments for pharmaceuticals in the environment (PIE).

Main Methods:

  • Comparative analysis of PV and EPV principles.
  • Case study reflection: Vulture decline in Asia (diclofenac) vs. intersex fish in Europe.
  • Exploration of practical measures for post-launch environmental risk assessment.

Main Results:

  • Significant differences exist between PV and EPV, particularly in environmental signal detection and causality.
  • Vulture decline illustrates a clear environmental impact, while intersex fish highlight detection difficulties.
  • Proposed measures include post-launch monitoring, Environmental Risk Management Plans (ERMPs), and increased data transparency.

Conclusions:

  • EPV requires careful consideration of environmental complexities.
  • Proactive measures are essential for timely identification and management of PIE.
  • A global perspective and accessible data are crucial for effective EPV.