May 19, 2024  
2022-2023 College Catalog 
    
2022-2023 College Catalog [ARCHIVED CATALOG]

CRC 240 - Pharmacology for Clinical Trials

4 Credits, 4 Contact Hours
4 lecture periods 0 lab periods

Essential drug knowledge and facts and their application in clinical research. Includes common medical diagnoses and their related drug treatments (brand name and generic); what constitutes a drug; the effects and modes of action of drugs upon the body (pharmacodynamics); method and rate of excretion and duration of the effect of drugs (pharmacokinetics); drug side effects; drug-drug interactions; and how to find and interpret drug-related information from primary literature. Also includes an overview of the drug development process from bench through post-approval marketing.

Prerequisite(s): CRC 101  
  button image Prior Learning and link to PLA webpage

Course Learning Outcomes
  1. Summarize the drug development process from a pharmaceutical perspective.
  2. Define pharmacology terminology.
  3. Explain the principles and process of clinical pharmacokinetics.
  4. Discuss factors that influence drug absorption, drug distribution, drug metabolism, and drug excretion.
  5. Independently research drug-related information from reference sources.
  6. Categorize drugs based on indication and mechanism of action.
  7. Identify the effects of pharmacogenetics and their relationship to drug
    development.
  8. Discuss common medical diagnoses and the related common
    drug treatments (brand and generic), including the drug actions and side effects.
  9. Evaluate the most prevalent and serious adverse effects associated with common prescription and over-the-counter drugs.

Outline:
  1. Pharmacokinetics
    1. Half-life
    2. Drug Vehicle
    3. Therapeutic range
    4. Steady-state
    5. Bioavailability
    6. Routes of administration
    7. Absorption, distribution, metabolism and excretion (ADME)
  2. Pharmacodynamics
    1. Effects of drug
    2. Mechanism of drug action
    3. Dose and concentration response
    4. Selectivity of drug action
  3. General Concepts and Terminology
    1. Explanation of drug metabolism
    2. Drug interactions
    3. Biotransformation pathways
    4. Pharmacogenetics
    5. Prodrugs
  4. Adverse Reactions
    1. Reactions
      1. Adverse reactions
      2. Serious adverse reactions
    2. Allergic reactions to report
    3. How to report
  5. Drug Development
    1. Target identification
    2. Screening for lead compounds
    3. Animal testing
    4. Investigational new drug (IND) application
    5. Phase - dose finding
    6. Phase II - assessment of response rate in different populations or pathologies
    7. Phase III - assessment of response compared to standard of care)
    8. NDA FDA review
    9. Phase IV - after market testing
  6. Common Medical Diagnoses and Drug Treatments
    1. Diabetes
      1. Names of common drugs (brand names and generic)
      2. Different classes of drugs to treat the indication
      3. Action of the drugs
      4. Significant side effects of the drugs
    2. Hypertension        
      1. Names of common drugs (brand names and generic)
      2. Different classes of drugs to treat the indication
      3. Action of the drugs
      4. Significant side effects of the drugs
    3. Cholesterol and triglycerides
      1. Names of common drugs (brand names and generic)
      2. Different classes of drugs to treat the indication
      3. Action of the drugs
      4. Significant side effects of the drugs
    4. Heart disease
      1. Names of common drugs (brand names and generic)
      2. Different classes of drugs to treat the indication
      3. Action of the drugs
      4. Significant side effects of the drugs
    5. Pulmonary disease
      1. Names of common drugs (brand names and generic)
      2. Different classes of drugs to treat the indication
      3. Action of the drugs
      4. Significant side effects of the drugs
    6. Osteoporosis
      1. Names of common drugs (brand names and generic)
      2. Different classes of drugs to treat the indication
      3. Action of the drugs
      4. Significant side effects of the drugs
    7. Gastrointestinal diseases
      1. Names of common drugs (brand names and generic)
      2. Different classes of drugs to treat the indication
      3. Action of the drugs
      4. Significant side effects of the drugs
    8. Depression/anxiety/insomnia
      1. Names of common drugs (brand names and generic)
      2. Different classes of drugs to treat the indication
      3. Action of the drugs
      4. Significant side effects of the drugs
  7. Drugs Used for Multiple Diagnoses/Indications 
    1. Steroids    
      1. Names of common drugs (brand names and generic)
      2. Different classes of drugs to treat the indication
      3. Action of the drugs
      4. Significant side effects of the drugs
    2. NSAIDS
      1. Names of common drugs (brand names and generic)
      2. Different classes of drugs to treat the indication
      3. Action of the drugs
      4. Significant side effects of the drugs
    3. Pain relievers
      1. Names of common drugs (brand names and generic)
      2. Different classes of drugs to treat the indication
      3. Action of the drugs
      4. Significant side effects of the drugs
  8. Over-the-Counter Drugs (OTC’s) and Supplements
    1. OTC’s
      1. Names of common drugs (brand names and generic)
      2. Different classes of drugs to treat the indication
      3. Action of the drugs
      4. Significant side effects of the drugs
    2. Supplements
      1. Importance of documentation
      2. Interactions with prescription medications