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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...
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...
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...
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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...
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...

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Starting a pharmacovigilance center: Actions for implementation.

Mrinmoy Chakrabarty1, Vijay Thawani

  • 1Department of Pharmacology, Veer Chandra Singh Garhwali Govt. Medical Science and Research Institute, Srinagar - 246 174, Garhwal, Uttarakhand, India.

Journal of Pharmacology & Pharmacotherapeutics
|October 26, 2011
PubMed
Summary
This summary is machine-generated.

Pharmacovigilance (PV) is crucial due to increasing adverse drug reactions. This article explains the structure and function of PV centers to educate healthcare professionals, supporting a national directive for medical colleges in India.

Keywords:
Pharmacovigilanceadverse drug reactionsdrug safetypharmacovigilance

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Area of Science:

  • Pharmacovigilance
  • Drug Safety
  • Healthcare Management

Background:

  • Increasing reports of adverse drug reactions (ADRs) highlight the importance of pharmacovigilance (PV).
  • Many healthcare professionals lack a full understanding of PV's significance in modern medicine.
  • A national directive mandates establishing PV centers in all Indian medical colleges.

Purpose of the Study:

  • To inform and educate healthcare professionals about pharmacovigilance.
  • To elucidate the essential components and operational dynamics of a pharmacovigilance center.
  • To support the implementation of PV centers in medical colleges across India.

Main Methods:

  • This article provides an informative overview.
  • It focuses on the conceptualization and operational aspects of PV centers.
  • No specific experimental methods were employed; it is a descriptive and educational piece.

Main Results:

  • The article aims to clarify the structure and function of PV centers.
  • It seeks to enhance the understanding and appreciation of pharmacovigilance among healthcare professionals.
  • It serves as a foundational resource for establishing and operating PV centers.

Conclusions:

  • Establishing functional pharmacovigilance centers is essential for improving drug safety.
  • Educating healthcare professionals on PV is critical for its successful implementation.
  • This initiative supports India's national health policy for better therapeutic outcomes.