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 Information: Students must be admitted to or have conditional status of the Clinical Research AAS or Post-Degree Certificate program or obtain the consent of the instructor before enrolling in this course. Course Learning Outcomes
Summarize the drug development process from a pharmaceutical perspective.
Define pharmacology terminology.
Explain the principles and process of clinical pharmacokinetics.
Discuss factors that influence drug absorption, drug distribution, drug metabolism, and drug excretion.
Independently research drug-related information from reference sources.
Categorize drugs based on indication and mechanism of action.
Identify the effects of pharmacogenetics and their relationship to drug
development.
Discuss common medical diagnoses and the related common
drug treatments (brand and generic), including the drug actions and side effects.
Evaluate the most prevalent and serious adverse effects associated with common prescription and over-the-counter drugs.
Outline:
Pharmacokinetics
Half-life
Drug Vehicle
Therapeutic range
Steady-state
Bioavailability
Routes of administration
Absorption, distribution, metabolism and excretion (ADME)
Pharmacodynamics
Effects of drug
Mechanism of drug action
Dose and concentration response
Selectivity of drug action
General Concepts and Terminology
Explanation of drug metabolism
Drug interactions
Biotransformation pathways
Pharmacogenetics
Prodrugs
Adverse Reactions
Reactions
Adverse reactions
Serious adverse reactions
Allergic reactions to report
How to report
Drug Development
Target identification
Screening for lead compounds
Animal testing
Investigational new drug (IND) application
Phase - dose finding
Phase II - assessment of response rate in different populations or pathologies
Phase III - assessment of response compared to standard of care)
NDA FDA review
Phase IV - after market testing
Common Medical Diagnoses and Drug Treatments
Diabetes
Names of common drugs (brand names and generic)
Different classes of drugs to treat the indication
Action of the drugs
Significant side effects of the drugs
Hypertension
Names of common drugs (brand names and generic)
Different classes of drugs to treat the indication
Action of the drugs
Significant side effects of the drugs
Cholesterol and triglycerides
Names of common drugs (brand names and generic)
Different classes of drugs to treat the indication
Action of the drugs
Significant side effects of the drugs
Heart disease
Names of common drugs (brand names and generic)
Different classes of drugs to treat the indication
Action of the drugs
Significant side effects of the drugs
Pulmonary disease
Names of common drugs (brand names and generic)
Different classes of drugs to treat the indication
Action of the drugs
Significant side effects of the drugs
Osteoporosis
Names of common drugs (brand names and generic)
Different classes of drugs to treat the indication
Action of the drugs
Significant side effects of the drugs
Gastrointestinal diseases
Names of common drugs (brand names and generic)
Different classes of drugs to treat the indication
Action of the drugs
Significant side effects of the drugs
Depression/anxiety/insomnia
Names of common drugs (brand names and generic)
Different classes of drugs to treat the indication
Action of the drugs
Significant side effects of the drugs
Drugs Used for Multiple Diagnoses/Indications
Steroids
Names of common drugs (brand names and generic)
Different classes of drugs to treat the indication
Action of the drugs
Significant side effects of the drugs
NSAIDS
Names of common drugs (brand names and generic)
Different classes of drugs to treat the indication
Action of the drugs
Significant side effects of the drugs
Pain relievers
Names of common drugs (brand names and generic)
Different classes of drugs to treat the indication
Action of the drugs
Significant side effects of the drugs
Over-the-Counter Drugs (OTC’s) and Supplements
OTC’s
Names of common drugs (brand names and generic)
Different classes of drugs to treat the indication