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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...
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 Abuse and Addiction: Pharmacological Phenomena01:15

Drug Abuse and Addiction: Pharmacological Phenomena

Drug dependence, abuse, and addiction are complex phenomena that can precipitate various abnormal states. Physical dependence refers to a state of pharmacological adaptation to a drug. This adaptation often results in tolerance—a reduced response to the drug after repeated administrations. When the drug use is abruptly stopped, withdrawal symptoms occur due to the body's need to readjust from the pharmacologically induced imbalance. However, tolerance and withdrawal symptoms do not necessarily...
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...
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,...
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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High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
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Assessing abuse liability during drug development: changing standards and expectations.

K A Schoedel1, E M Sellers

  • 1Clinical Pharmacology Group, DecisionLine Clinical Research Corporation, Toronto, Ontario, Canada. k.schoedel@dlcrc.com

Clinical Pharmacology and Therapeutics
|January 24, 2008
PubMed
Summary

Regulatory expectations for assessing the abuse liability of new central nervous system (CNS) drugs have increased. Comprehensive evaluations are now required for CNS-active drugs exhibiting stimulant, depressant, or mood-altering properties.

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Area of Science:

  • Pharmacology
  • Neuroscience
  • Public Health

Background:

  • Evolving public health concerns necessitate updated regulatory standards for drug abuse potential.
  • Central nervous system (CNS) active drugs require rigorous abuse liability assessment.
  • Increased scrutiny applies to drugs with stimulant, depressant, hallucinogenic, or mood-elevating effects.

Purpose of the Study:

  • To outline the expanded regulatory requirements for assessing the abuse liability of new CNS drugs.
  • To detail the multifaceted approach to abuse liability evaluation.

Main Methods:

  • Data collection and analysis encompassing drug chemistry and tampering potential.
  • Assessment of animal behavioral pharmacology models.
  • Review of clinical trial adverse events (AEs), diversion, and overdose data.
  • Evaluation of reinforcing effects in human recreational drug users.

Main Results:

  • Abuse liability assessment is a mandatory component for CNS-active drugs.
  • A comprehensive data-driven approach is essential for regulatory compliance.
  • Multiple data streams inform the overall abuse liability profile.

Conclusions:

  • The assessment of abuse liability for CNS drugs is increasingly critical.
  • A thorough evaluation requires integrating diverse data sources.
  • Regulatory bodies expect a robust analysis of potential drug abuse risks.