Regulatory Approval

Pharmacology · Part 1

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Table of Contents

  1. 1.NDA/BLA Submission
  2. 2.Review Process
  3. 3.Accelerated Pathways
  4. 4.Global Regulatory Bodies
  5. 5.New Drug Application (NDA)
  6. 6.Biologics License Application (BLA)
  7. 7.Common Technical Document (CTD)
  8. 8.Accelerated Approval
  9. 9.Orphan Drug Designation
  10. 10.Emergency Use Authorization (EUA)

Course Context

This PDF is part of the Pharmacology course on CoursesHub.World. Master the science of drug action and mechanism. Covers pharmacokinetics (ADME), pharmacodynamics, molecular pharmacology, autonomic and CNS pharmacology, cardiovascular drugs, chemotherapy, endocrine...

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