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Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

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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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Bioequivalence studies: Biowaivers01:13

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Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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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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Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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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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Two-Year US Pharmacovigilance Report on Brodalumab.

Mark Lebwohl1, Craig Leonardi2, Jashin J Wu3

  • 1Icahn School of Medicine at Mount Sinai, New York, NY, USA. lebwohl@aol.com.

Dermatology and Therapy
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Brodalumab (Siliq) is a safe treatment for moderate-to-severe plaque psoriasis. Two-year US pharmacovigilance data showed no completed suicides or serious fungal infections, supporting its established safety profile.

Keywords:
Adverse eventsBrodalumabPharmacovigilancePsoriasisReal-world dataSafetySuicidal ideation and behavior

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Area of Science:

  • Dermatology
  • Pharmacovigilance
  • Immunology

Background:

  • Brodalumab is an interleukin-17 receptor A antagonist for moderate-to-severe plaque psoriasis.
  • US labeling includes a boxed warning for suicidal ideation and behavior.
  • Previous 1-year data showed psoriasis flare as the most common adverse event, with no completed suicides.

Purpose of the Study:

  • To provide a 2-year US pharmacovigilance report on brodalumab.
  • To assess the safety profile of brodalumab in a real-world setting.
  • To monitor adverse events, including those of special interest.

Main Methods:

  • Analysis of pharmacovigilance data reported by US patients and healthcare providers.
  • Data collection period: August 15, 2017, to August 14, 2019.
  • Inclusion of common adverse events (≥1%) and adverse events of special interest.

Main Results:

  • 2677 patients with 1656 patient-years of exposure.
  • Arthralgia was the most common adverse event (0.04 events/patient-year).
  • No suicide attempts or completed suicides; 25 depression reports. 46 serious infections, no serious fungal infections. 13 malignancies, none related to brodalumab.

Conclusions:

  • The 2-year US pharmacovigilance data support the safety profile of brodalumab.
  • Findings align with previous long-term clinical trial and 1-year pharmacovigilance data.
  • Brodalumab demonstrates a consistent safety profile in managing plaque psoriasis.