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Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

2.0K
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...
2.0K
Drug Regulation01:25

Drug Regulation

3.3K
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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FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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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,...
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Therapeutic Drug Monitoring: Affecting Factors01:29

Therapeutic Drug Monitoring: Affecting Factors

384
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.
384
Therapeutic Drug Monitoring: Overview and Classification01:16

Therapeutic Drug Monitoring: Overview and Classification

574
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...
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Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

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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...
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Intraventricular Drug Delivery and Sampling for Pharmacokinetics and Pharmacodynamics Study
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[Pharmacovigilance update].

Nathalie Fogarasi Szabo, Léonore Diezi, Laurie Delenclos

    Revue Medicale Suisse
    |March 25, 2015
    PubMed
    Summary
    This summary is machine-generated.

    This review highlights 2014 pharmacovigilance updates, detailing drug safety concerns like cardiovascular risks with Ivabradine and heart failure with Axitinib, alongside other adverse events for various medications.

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    Area of Science:

    • Pharmacovigilance and Drug Safety
    • Clinical Pharmacology
    • Adverse Drug Reactions

    Context:

    • The year 2014 saw significant pharmacovigilance updates concerning various medications.
    • Monitoring drug safety is crucial for patient well-being and effective treatment.

    Purpose:

    • To review and summarize key pharmacovigilance updates from 2014.
    • To inform healthcare professionals about newly identified or emphasized drug safety risks.

    Summary:

    • Ivabradine use in angina patients at high dosages is linked to increased cardiovascular death and myocardial infarction.
    • Rare cases of acquired hemophilia with Clopidogrel, reduced HIV antiretroviral absorption with Orlistat, and arteriopathy/thrombosis risk with Ponatinib were noted.
    • Axitinib carries a significant risk of heart failure (class effect), Tocilizumab may relate to psoriasis, and Lithium can cause hypercalcemia/hyperparathyroidism.
    • Sildenafil's association with melanoma is under investigation, Methylphenidate has rare priapism reports, and St. John's Wort reduces hormonal contraceptive effectiveness.

    Impact:

    • Provides timely information on drug safety to clinicians, aiding in risk assessment and patient management.
    • Highlights the dynamic nature of drug safety monitoring and the importance of ongoing research.
    • Contributes to a safer medication use environment by disseminating critical safety alerts.