Drug Regulation Flashcards
The FDA regulates what _____ the manufacturer can place in the package insert and what ____ the manufacturer makes, but cannot regulate _____ by a physician.
indications for drug use; health claims; how a drug is actually used
Name 2 drug categories that advise consistent use of either the brand or generic drug.
levothyroxine; anti-epileptic drugs
The second phase of new drug testing is _____.
clinical trials in humans
The bioequivalence variation of generics to the parent drug is ____.
less than 4%
What is the first step in the evaluation of a new drug?
animal studies (rodents and non-rodents)
After a phase III human clinical trial, the company can submit a ______ to the FDA for approval.
new drug application (NDA)
A phase II human clinical trial test for _____, ____, ____, and ____ using _____.
safety, efficacy, dosing, toxicities; a select pt pool of 200-300 w/o prior medical problems
A phase I clinical trial determines ____ and _____ using _____.
safety, pharmacokinetics; healthy male volunteers
A ______ describes the effect a substance has on reducing the risk of or preventing a disease,
health claim
Clinical trials in humans includes ___ phases.
3
(are/aren’t) OTC drugs ____ evaluated, ____ prescription only, and _____ potentially abused.
are, are not, are not
A ________ is defined as a product intended to supplement the diet that contains a vitamin, mineral, amino acid, or herb/botanical and is not represented as food.
dietary supplement
The Food, Drug, and Cosmetic of 1938 (and Kefauver Amendments of 1962) requires that for new drugs and for drugs released since 1938 manufacturers must demonstrate ______ as well as _____ before they can be marketed to the public.
proof of efficacy; safety
Low incidence drug effects will be missed in phases ___.
I-III
The FDA requires that _____ must be met for generics.
bioequivalence standards
A _____ is defined as a therapeutic agent intended to diagnose, treat, cure, or prevent a disease.
drug
A ______ describes the role of a substance intended to maintain the structure or function of the body.
structure/function claim
(are/aren’t) Dietary supplements ____ evaluated, ____ prescription only, and _____ potentially abused.
are not, are not, are not
(are/aren’t) Controlled substances ____ evaluated, ____ prescription only, and _____ potentially abused.
are, are, are
How many phases of drug testing are there?
5- 1 in animals, 4 in humans
A health claim requires ______ prior to its use.
FDA evaluation and authorization
(are/aren’t) Prescription drugs ____ evaluated, ____ prescription only, and _____ potentially abused.
are, are, are (but very low risk)
It is assumed that bioequivalent drugs are _____, and proof is not required by the FDA.
therapeutically equivalent
A phase III human clinical trial tests ____ and _____ using a ____ study and ______ participants.
efficacy, chronic use; double blind; 1000-6000
