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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.
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Bioequivalence studies: Biowaivers01:13

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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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Subviral Agents01:29

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Subviral agents are infectious entities that resemble viruses but lack one or more viral components, such as a capsid or essential replication machinery. These agents include viroids, prions, and satellites, each possessing distinct structural and functional characteristics that influence their mode of infection and replication.Viroids are the simplest subviral agents, consisting of circular, single-stranded RNA molecules without a protein coat. They exclusively infect plants, relying entirely...
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Bioavailability Study Design: Healthy Subjects Versus Patients01:15

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Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
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Bioavailability Study Design: Single Versus Multiple Dose Studies01:11

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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...
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Related Experiment Video

Updated: Apr 16, 2026

Quantitative Structure-Activity Relationship, Activity Prediction, and Molecular Dynamics of Non-nucleotide Reverse Transcriptase Inhibitors
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The maraviroc expanded access program - safety and efficacy data from an open-label study.

Adriano Lazzarin, Jacques Reynes, Jean-Michel Molina

    HIV Clinical Trials
    |March 18, 2015
    PubMed
    Summary

    Maraviroc (MVC) demonstrated good tolerability in HIV patients with limited options. Virologic suppression was achieved in most patients receiving MVC with new antiretroviral therapies.

    Keywords:
    Antiretroviral agentsDarunavir,Etravirine,HIV,Maraviroc,Raltegravir,

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    Area of Science:

    • Infectious Diseases
    • Virology
    • Clinical Pharmacology

    Background:

    • The maraviroc (MVC) expanded access program (EAP) provided access to MVC for patients with limited treatment options.
    • New antiretroviral therapies (ARVs) like darunavir (DRV), raltegravir (RAL), and etravirine (ETV) were available for coadministration with MVC.
    • This facilitated the assessment of MVC safety in combination with novel ARVs.

    Purpose of the Study:

    • To assess the safety and tolerability of maraviroc (MVC) in treatment-experienced HIV-1-positive patients with limited therapeutic options.
    • To evaluate MVC in combination with various new antiretroviral therapies (ARVs).

    Main Methods:

    • An open-label, multinational safety study involving 1032 R5 HIV-positive patients.
    • Patients received MVC with optimized background therapy (OBT) and/or new ARVs (DRV, RAL, ETV).
    • Safety data were analyzed overall and by specific ARV combination subgroups.

    Main Results:

    • Most adverse events (AEs) were mild or moderate (90.3%), with few severe events or discontinuations.
    • Virologic suppression was observed, with 79.9% of patients achieving HIV-1 RNA <400 copies/ml and 50% <50 copies/ml.
    • Viral escape mechanisms included tropism changes and selection of MVC-resistant R5 virus.

    Conclusions:

    • Maraviroc (MVC) was well tolerated in this patient population.
    • Virologic suppression was achieved in the majority of patients treated with MVC and new ARVs.