『How the FDA Ensures Drug Safety – From Lab to Approval』のカバーアート

How the FDA Ensures Drug Safety – From Lab to Approval

How the FDA Ensures Drug Safety – From Lab to Approval

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Title: How the FDA Ensures Drug Safety – From Lab to Approval

Episode Summary: Ever wondered how the FDA makes sure every medication is safe and effective before it reaches your pharmacy shelf? In this episode of Talking in the Woods – Science Behind the Script, host Christopher Wood takes you behind the scenes of drug development—from early lab studies to full FDA approval.

What You’ll Learn in This Episode:

  • The preclinical phase: in vitro and in vivo testing, genotoxicity, and pharmacokinetics
  • Clinical trial phases: What happens in Phase I, II, and III
  • NDA vs BLA: What these regulatory terms mean and why they matter
  • FDA review timelines: Standard vs Breakthrough Therapy designation
  • Safety reporting and labeling, including the infamous black box warning

🎧 Listen now to understand the science behind safer medicines.

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