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Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

1.9K
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...
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Drug Regulation01:25

Drug Regulation

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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

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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.
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Therapeutic Drug Monitoring: Overview and Classification01:16

Therapeutic Drug Monitoring: Overview and Classification

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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].

Kim Dao, Haithem Chtioui, Laura E Rothuizen

    Revue Medicale Suisse
    |March 8, 2016
    PubMed
    Summary
    This summary is machine-generated.

    Pharmacovigilance updates in 2015 highlight drug safety concerns. Key findings include interactions with sofosbuvir, dasabuvir, and SGLT2 inhibitors, alongside risks associated with ibuprofen, pregabalin, and varenicline.

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    Area of Science:

    • Pharmacovigilance and Drug Safety
    • Clinical Pharmacology
    • Regulatory Science

    Context:

    • Review of significant pharmacovigilance findings reported in 2015.
    • Focus on newly identified or reinforced drug safety signals.
    • Covers a range of therapeutic classes and drug interactions.

    Purpose:

    • To summarize critical pharmacovigilance updates from 2015.
    • To inform healthcare professionals about potential drug risks and interactions.
    • To emphasize the importance of ongoing drug safety monitoring.

    Summary:

    • Sofosbuvir-amiodarone interaction may cause severe bradycardia.
    • Dasabuvir-clopidogrel interaction increases dasabuvir levels and QT prolongation risk.
    • SGLT2 inhibitors linked to diabetic ketoacidosis and bone fractures.
    • Dabigatran monitoring may optimize its benefit-risk profile.
    • High-dose ibuprofen shows vascular risks similar to coxibs.
    • Pregabalin and gabapentin carry risks of abuse and addiction.
    • Varenicline can enhance alcohol's effects.
    • Codeine is contraindicated for cough in children under twelve.
    • Valproate use in pregnancy carries strengthened warnings.
    • Dimethylfumarate and ustekinumab have rare associations with PML and erythrodermia, respectively.

    Impact:

    • Informed clinical decision-making regarding drug prescriptions and monitoring.
    • Enhanced patient safety through awareness of potential adverse events.
    • Contributed to updated drug safety guidelines and recommendations.