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Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs01:26

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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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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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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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This summary is machine-generated.

Remdesivir, an antiviral drug, shows promise for treating COVID-19. Following promising Phase III trials, it received conditional approvals globally, starting with Taiwan in May 2020.

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Area of Science:

  • Virology
  • Infectious Diseases
  • Pharmacology

Background:

  • Remdesivir is a broad-spectrum antiviral nucleotide analogue prodrug.
  • It demonstrated potent activity against coronaviruses in preclinical studies.
  • Remdesivir emerged as a potential treatment for COVID-19 during the global pandemic.

Purpose of the Study:

  • To summarize the development milestones of remdesivir.
  • To document its path to conditional approval for COVID-19 treatment.

Main Methods:

  • Review of preclinical data on remdesivir's antiviral activity.
  • Analysis of Phase III clinical trial results for COVID-19 treatment.
  • Chronological tracking of regulatory approvals and emergency use authorizations.

Main Results:

  • Phase III evaluations of remdesivir for COVID-19 treatment yielded promising results.
  • Remdesivir received conditional approval in Taiwan in late May 2020.
  • Subsequent conditional approvals were granted in the EU and Canada, preceded by emergency use authorizations in the USA and Japan.

Conclusions:

  • Remdesivir's development progressed rapidly, leading to its initial conditional approval for severe COVID-19.
  • The drug's broad-spectrum activity and promising clinical data supported its regulatory milestones.