What is the FDA's definition of a new drug?
What are the two most common sites with which we measure drug amount/ concentration?
Plasma and urine concentration
What is the difference between quantitative and qualitative?
Quantitative is number based and qualitative is interpretation based
What route of administration describes sublingually?
Under the tongue
What is half-life?
time required for drug in the plasma to decrease by 50%
What is the difference between systemic and non-systemic?
Systemic - All over the body
Within body fluids
Within cells
Embedded in cell membranes
May also be non-systemic
Skin
GI-tract
What is meant by orphan drug?
What is ANDA?
Abbreviated NDA
This process happens when a drug is available for another company to make a generic form of it. This means the the med has gone through the full NDA and the FDA determined the information on the exempted and non clinical studies is already available to the agency
What is SNDA?
Supplemental New Drug application (SNDA)
What is volume of distribution?
how well the drug is distributed in the body
What is bioavailability?
(percent or fraction) of a dose of unchanged drug that reaches systematic circulation
What is pharmaceutics?
examines physiochemical properties of drugs and dosage forms
What is pharmacokinetics?
studies movement of drugs within the body
What is biopharmaceutics?
examine interrelationship between properties of drugs, dosage forms, and the route of administration
What is clearance?
volume of plasma cleared of drug per unit time
What is NDA?
New Drug Application (a comprehensive document)
What information can be found in USP/NF?
Monographs for drug substances, dietary substances, dosage forms, and compounded preparations
(Standards include strength, purity, quality, and packaging and labeling)
What is the FDA's stance of dietary supplements?
They are not legally considered drugs if they have not been submitted for review on NDA’S and haven’t been evaluated for safety and efficiency by the FDA however their proper usage is a concern.
What does NDC stand for and what are the components?
What is the IND?
Investigational New Drug Application (IND)
What are the components of LADME and describe them?
Liberation (release of the drug), Absorption (absorbed through the bloodstream), Distribution (distributes to various parts of the body) , Metabolism (by enzymes), and Excretion (through the kidneys or other routes).
What are the three classes of drug recalls? (Explain)
What are the differences between the five scheduled drug classes?
What are the differences between phases 0 and 4?
What are the required elements of drug labeling?
Required portions of package insert
Portions of the drug label