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Oncology Clinical Trials.pdf

FDA-Guidelines-AdoInAdultTrial.pdf
Preview of Oncology Clinical Trials
🔗 Source: cerped.fr
📊 Size: 164 KB
👤 Author: FDA/CDER/MCCRAYK
⬇️ Downloads: 135

Summary

The FDA guidance considers the inclusion of adolescent patients (ages 12-17) in adult oncology clinical trials, recommending their inclusion in disease- and target-appropriate trials to enable earlier access to investigational and approved drugs. The guidance discusses criteria for inclusion, dosing and pharmacokinetic evaluations, safety monitoring, and ethical requirements, encouraging sponsors to contact the responsible FDA review division to discuss details of the program before implementation.

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Description

The FDA guidance considers the inclusion of adolescent patients (ages 12-17) in adult oncology clinical trials, recommending their inclusion in disease- and...

Technical Information

  • File Format: PDF
  • File Size: 164 KB
  • Pages: 7
  • Language: EN
  • Author: FDA/CDER/MCCRAYK
  • Total Downloads: 135
  • Last Updated: 1 week ago

Document Overview

This PDF document about Oncology Clinical Trials provides comprehensive information and guidance. Whether you're a beginner or advanced user, this resource offers valuable insights into Oncology Clinical Trials.

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Oncology guideOncology tutorialClinical guideClinical tutorialTrials guideTrials tutorial

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