What is pharmacology
Study of how drugs affect a biological system
What is a drug
Any chemical agent which affects any biological process
What are the mechanisms of action for drugs
Replace/substitute for other chemicals, increase or stimulate certain cellular activities, depress or slow certain cellular activities, and interfere w/ function of foreign cells
What is drug classification based on
Chemical structure, main effect, therapeutic use, and mechanism of action
What are the 3 types of drug nomenclature
Chemical name, generic name, and trade name
What are the 3 forms of drug formulation
Dosage (mg/kg), concentration (mg/ml), and injection volume (ml/kg)
How are drugs developed
10-15 (or more) years for development/testing/approval that can be broken down into stages such as drug discovery and screening, pre clinical safety and toxicity testing, and evaluating drugs in humans
What is the drug discovery and drug screening stage (stage 1)
Chemical development w/ in vitro studies to look at the function in cells, tissues, and at receptors
What is the pre clinical safety and toxicity testing stage (stage 2)
In vivo animal studies w/ pharmacology and behavioral pharmacology by looking at potency/efficacy (ED50) and tolerance then for toxicity looking at acute or chronic, LD50, teratogenicity, and carcinogenicity
What are teratogens
Something that causes a birth defect
What is LD50
Lethel dose in 50% of population
When are animals used for stage 2 of drug development
When no alternatives or non-animal replacements exist
What is carcinogenicity
Causes cancer
What is stage 3 in drug development
To evaluate the drugs in humans the preclinical testing is sent to the FDA that reviews the process and could approve clinical trials
What is a phase 1 drug clinical trial
Healthy adults volunteers w/ about 20-80 individuals looking for safety, pharmicokentics, and side effects
What is a phase 2 drug clinical trial
W/ <300 patients looking at efficacy, safety, pharmicokentics, and side effects this is single blind placebo controlled
What is a single blind placebo clinical trial
A placebo is used but the patient doesn’t know which one they get
What is a phase 3 drug clinical trial
Specific patient subpopulations typically <3000 looking for specific indications that is double blind placebo controlled
What is a phase 4 drug clinical trial
Post FDA approval that looks for specific indications for drug utilization patterns, additional efficacy, monitors rare or severe side effects or toxicity
What is pharmacokinetics
What the body does to drug
What is pharmacodynamics
What the drug does to the body
What are pharmacotherapeutics
The clinical purpose or indication
What is pharmacognosy
Identifying crude materials as drugs
W/in pharmacognosy what are sources of drugs
Plants, animals, minerals, microbes, and synthetics