Pharmacology introduction Flashcards
introduction
What is Pharmacology?
The science of chemicals that effect a living process
what is toxicology?
adverse effects of chemicals
What is drug therapy?
“management” of disease with a medication.
- cure is rare for example antibiotics
what is a drug?
alters an effect already existing in a quatitative manner of changes
1938 Food and Drug Cosmetic Act
- must prove safety
- missing efficacy
1962 Kefaver- Harris Amendment
- Must prove efficacy
- grandfather clause
- any drug before 1962 is exempt.it takes 20 more years for FDA to check grandfather clause
NOTE:
- herbal products not regulated by FDA
- no testing of eficacy
- no purity
- an herbal cannot make claim to treat a disease
when is it require to report?
- chemical or substance not previously used in humans
- new combination not used in combination before
- new use for a previously issued drug
- new dosage form
NOTE:
- Doctors can do whatever they want as long as the drug has been approved
- the drug companies cannot advertise it
How many phases?
4
what is phase 1?
determine safety and tolerated dose in a few “healthy” volunteers
NOTE:
- on animals first
- not to another group who already has the disease
Phase 2
Determine safety, efficacy and pharmacokinetics in selected “diseased” individuals
phase 3
determine safety and efficacy in widespread study
Phase 4
drug marketed with surveillance
what are the types of studies?
Double blind and single blind
Double Blind
investigator and paitent does not know what they are getting very unbiased.
Single blind
Investigator knows whitle the patient does not
NOTE:
- if a patient is in a study and then gets sickthe drug name has to be known to the patient and then they are kicked out of the study
Generic Name
cheimcal name for a medication
NONE CAPITALIZE
trade name
a manufacturer’s name for the generic product
For example: Motrin, Advil