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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...
Teratogenicity01:07

Teratogenicity

The ability of a drug to produce structural deformations and functional abnormalities in the developing embryo or the fetus is called teratogenicity, and the drug producing this effect is known as a teratogen. Teratogenic effects include stillbirth, miscarriage, intrauterine growth restriction, and neurocognitive delay. A teratogen may affect the embryo at different stages of development, which is important in determining the type and extent of the damage. During blastocyst formation, the early...
Therapeutic Drug Monitoring: Overview and Classification01:16

Therapeutic Drug Monitoring: Overview and Classification

Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood at designated intervals to ensure the drug concentration stays within a therapeutic range. This monitoring is crucial for optimizing individual dosage regimens, enhancing therapeutic efficacy, and minimizing drug-related toxicity. TDM is vital for drugs with narrow therapeutic windows, significant variability in pharmacokinetics, and a clear correlation between plasma levels and...
Therapeutic Drug Monitoring: Affecting Factors01:29

Therapeutic Drug Monitoring: Affecting Factors

Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
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...

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Related Experiment Video

Updated: Jul 16, 2026

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

[Pharmacovigilance and teratovigilance].

Françoise Livio1, Thierry Buclin, Jérôme Biollaz

  • 1Division de pharmacologie et toxicologie cliniques, Hôpital de Beaumont, CHUV, 1011 Lausanne. francoise.livio@chuv.hospvd.ch

Revue Medicale Suisse
|March 16, 2007
PubMed
Summary

In 2006, new drug safety data emerged, highlighting risks like cardiovascular events with erythropoietins and congenital anomalies with paroxetine. Prescribers should note these adverse drug reactions to ensure patient safety.

Related Experiment Videos

Last Updated: Jul 16, 2026

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

Area of Science:

  • Pharmacovigilance
  • Drug Safety Monitoring
  • Clinical Pharmacology

Context:

  • The year 2006 presented new data influencing drug safety profiles.
  • Several specific adverse drug reactions (ADRs) were identified or further characterized.

Purpose:

  • To review and highlight significant adverse drug reactions reported in 2006.
  • To inform healthcare prescribers about emerging drug safety concerns.

Summary:

  • Cardiovascular events associated with erythropoietins and methylphenidate.
  • Ocular (macular edema with rosiglitazone) and vascular/renal complications (aprotinine).
  • Long-term use concerns (linezolide), specific severe events (intracranial hemorrhage with tipranavir, anaphylaxis with pegaptanib), cardiotoxicity (imatinib), lymphomas (infliximab), bone pain (bisphosphonates).
  • Congenital anomalies (paroxetine, lamotrigine), neonatal pulmonary hypertension (serotonin reuptake inhibitors), and infantile respiratory depression (promethazine) were also noted.

Impact:

  • Modulates the understanding of established and novel drug safety profiles.
  • Emphasizes the need for ongoing vigilance and prescriber awareness regarding potential ADRs.
  • Contributes to informed clinical decision-making and patient risk management.