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Core Concepts in Pharmacology

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Stages of Therapeutic and Biologic Drug Approval. Preclinical investigation ... Recent Changes to Drug Approval Process. Prescription Drug User Fee Act. FDA ... – PowerPoint PPT presentation

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Title: Core Concepts in Pharmacology


1
Core Concepts in Pharmacology
  • Chapter 1
  • Introduction to Pharmacology
  • Drug Regulation and Approval

2
History of Pharmacology
  • Herbal medicine
  • Modern pharmacology
  • 1847
  • 1890
  • What is the central purpose of pharmacology?
  • How does the central purpose of pharmacology
    compare with the central purpose of nursing?

3
Terms to Understand
  • Pharmacology
  • Therapeutics
  • Pharmacotherapy (pharmacotheraputics)
  • What other disciplines are important?
  • How is knowledge of other subject areas
    (disciplines) helpful in understanding
    pharmacology?
  • How are these terms connected?

4
Pharmacology and Therapeutics
  • What is the role of the nurse in
    pharmacotherapeutics?
  • What must the nurse possess in order to perform
    nursing duties related to pharmacotherapeutics?

5
Lets Think About It
  • What are some of the challenges of pharmacology
    today?
  • What is required of the nurse?

6
Categories of Therapeutic Agents
  • Drugs
  • Biologics
  • Alternative Therapies
  • Define the above terms.
  • Can you think of examples for each term?

7
Dispensing Drugs
  • Prescription drugs
  • Over-the-counter (OTC) drugs
  • Compare and Contrast the above methods of
    dispensing drugs.

8
Regulating Drugs
  • Formulary
  • Pharmacopoeia
  • Why was it necessary to formally regulate drugs?
  • What is the role of the FDA?
  • When can a prescription drug become an OTC drug?

9
Stages of Therapeutic and Biologic Drug Approval
  • Preclinical investigation
  • Clinical investigation
  • Review of the New Drug Application (NDA)
  • Postmarketing surveillance

10
Recent Changes to Drug Approval Process
  • Prescription Drug User Fee Act
  • FDA Modernization Act
  • What are the benefits to streamlining this
    process?
  • What are the drawbacks?
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