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Related Concept Videos

Preclinical Development: Overview01:28

Preclinical Development: Overview

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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Factors Affecting Drug Response: Overview01:21

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When it comes to infants and young children, they are typically administered smaller doses of medication in comparison to adults. This is primarily because their organ functions still need to fully develop, meaning their bodies are not as efficient at metabolizing or eliminating drugs. Additionally, their blood-brain barrier is more permeable than in adults. As a result, high concentrations of drugs can easily penetrate the central nervous system (CNS), potentially leading to neurological...
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Clinical Trials: Overview01:11

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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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Drug Administration and Therapy Phases: Overview01:26

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Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
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Prescription, Nonprescription and Orphan Drugs01:02

Prescription, Nonprescription and Orphan Drugs

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Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
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Updated: Aug 27, 2025

Generation, Amplification, and Titration of Recombinant Respiratory Syncytial Viruses
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Considerations and Challenges in the Remdesivir COVID-19 Pediatric Development Program.

Kirk Chan-Tack1, Mario Sampson2, Justin Earp2

  • 1Division of Antivirals, Office of Infectious Diseases, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.

Journal of Clinical Pharmacology
|September 23, 2022
PubMed
Summary

The U.S. Food and Drug Administration expanded remdesivir (RDV) approval for pediatric COVID-19 patients. This antiviral is now available for hospitalized children and high-risk outpatients aged 28 days and older.

Keywords:
COVID-19antiviralpediatricsphysiologically based pharmacokinetic modeling

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Area of Science:

  • Pediatric infectious diseases
  • Antiviral drug development
  • Regulatory science

Background:

  • The U.S. Food and Drug Administration (FDA) sought effective antiviral treatments for pediatric coronavirus disease 2019 (COVID-19).
  • Remdesivir (RDV) was previously available under emergency use authorization for certain pediatric populations.
  • COVID-19 presents similarly in adults and pediatric patients, suggesting potential efficacy of adult-tested antivirals.

Purpose of the Study:

  • To detail the regulatory process and considerations for expanding remdesivir (RDV) indication to pediatric patients.
  • To summarize the development program for RDV in treating COVID-19 in neonates, infants, and children.
  • To discuss lessons learned from the pediatric RDV development and approval pathway.

Main Methods:

  • Review of safety and efficacy data from adult and adolescent Phase 3 trials.
  • Analysis of safety and pharmacokinetic data from a Phase 2/3 pediatric clinical trial (53 participants).
  • Examination of the evolution of Emergency Use Authorization (EUA) to full FDA approval for pediatric use.

Main Results:

  • On April 25, 2022, the FDA approved RDV for hospitalized pediatric patients and non-hospitalized, high-risk pediatric patients (≥28 days old, ≥3 kg) with confirmed SARS-CoV-2 infection.
  • The expanded indication was supported by adult trial data and pediatric pharmacokinetic and safety data.
  • The FDA simultaneously revoked the prior EUA for RDV in this pediatric population.

Conclusions:

  • The FDA's regulatory actions facilitated access to an effective antiviral for pediatric COVID-19.
  • The development program highlights the importance of pediatric-specific data alongside adult data for drug approval.
  • Key regulatory considerations and lessons learned from the RDV pediatric program can inform future pediatric antiviral development.