What are the 3 different names that drugs collect as they pass through the phases of drug trials before they are approved and sold?
chemical name
generic or "official" name
trade or brand name "proprietary" name
first name of a drug that is a description of the chemical composition and molecular structure (N-acetyl-P-aminophenol)
chemical name
second name of a drug that is a shorter name derived from the chemical name (e.g. acetaminophen)
generic or "official" name
third name of a drug that is the name a manufacturer copyrights and gives to its approved drug product (tylenol)
brand name or "proprietary" name
How long does the patent for exclusive manufacture and marketing of a drug last for?
approximately 17 years (of protection)
What are 2 examples of the same drug but have different names with different dose forms that they come in?
ibuprofen
lidocaine
before the FDA approves a drug, the generic name is assigned by the manufacturer with the approval of the _____ _____ ______ _______ _______
United States Adopted Name council
All drugs have one ______ name, but they can have numerous _______ names.
generic
brand
How do you avoid confusion between the generic name and brand name of a drug?
the generic name is lower case and the BRAND name is capitalized
a drug can be a perscriptiion, or ______ drug
legend
means a drug can be secured with a prescription or a drug can be a nonprescription drug and sold over the counter
Prescription (legend)
when multriple drugs are included into a single dose form
combination product
How are perscriptions drugs that were normally perscription only drugs sold over the counter?
in low doses considered safe for consumer purchase
Each year a list of the top ________ drugs perscribed the previous year is published, this list can be found on the internet
200
true or false. there are some exceptions, but most generic drug formulations are considered to be thera peutically equivalent to the brand name product
true
The ________ requires that the active ingredient of the generic product achieve the same therapeutic blood level as the brand-name product
FDA
when two formulations of a drug meet the same chemical and physical standards required by the FDA, they are described as what?
chemically equivalent
products that produce similar concentrations of the drug in the blood and tissues are what?
biologically equivalent
if clinical trials show the generic drug to have an equal therapeutic effect, it is described as what?
therapeutically equivalent
Only drugs that are ____________ equivalent can be marketed
biologically
Why are biologic and therapeutic equivalence the same?
because the amount of a drug in the blood or tissue is a requirement for a therapeutic effect
What are the 3 ways that drugs are classified as?
their intended use or indication
effect produced in the body
chemical categories
What is another example of a classification for individual drugs besides the 3 main ones?
FDA pregnancy safe category
What does the FDA pregnancy safety category indicate?
that documented problems have occurred in animals or humans when the drug is used during pregnancy
an agency within the department of health and human services charged with the responsibility to approve drugs that have been shown to be safe and effective. They also test food products to ensure they are safe to consume
FDA (food and drug administration)
What agency decides which drugs are sold by prescription and which drugs can be sold OTC?
FDA
enforces federal consumer protection laws and regulates marketing practices and advertising on foods, nonprescription drugs, dietary supplements, and products promising health benefits.
FTC (federal trade commission)
an agency within the department of justice that administers the requirements outlined in the controlled substances act; which indentifies drugs capable of causing addiction and sets requirements for prescribing drugs with potential for abuse
DEA (drug enforcement administration)
What are the 5 steps/phases of how a drug becomes FDA approved?
preclinical trials
Phase I clinical trial
Phase II clinical trial
Phase III clinical trial
Postmarketing surveillance
a new drug is tested in animals to prove its safety is what step for FDA approval?
preclinical trials
low doses of the drug are tested in a group of 20-80 healthy volunteers to study safety profiles and determine pharmacokinetic characteristics; is what step for FDA approval?
phase I clinical trial
controlled study involving 100 to 300 volunteers to assess the drug's effectiveness; is what step for FDA approval?
phase II clinical trials
controlled studies involving 1,000 to 3,000 volunteers to confirm the drug's safety and efficacy, and identify adverse drug effects; is what step for FDA approval?
phase III clinical trials
determine the true risk-benefit profile of the new drug; is what step in FDA approval?
