Drug Formulations
Many patients prefer these solid forms over tablets because their gelatin casing makes them slippery and easier to swallow when taken with water?
What are capsules
what agency must approve all new drugs before they can be marketed in the USA
FDA
The metal or plastic tool is used to move tablets across the tray
what is a spatula
Which class of recall poses the highest potential risk to patient health?
What is Class I
Participants in clinical trials must provide this written agreement before joining.
What is informed consent
Fillers, glue and colors are examples of these components often found in medications alongside the therapeutic chemical
What are inactive ingredients?
In a study where neither the participants nor the doctors know who is receiving the real drug, the trial is called this
What is a double blind study
This number on a stock bottle helps identify the exact drug product
What is the NDC number
These sugar based liquid formulations are common for cough medications
What are syrups
A recall that poses a strong chance adverse effects or death in this class
what is Class I recall
Tablets placed under the tongue such as nitroglycerin, is classified as this type of tablet?
The FDA classifies drug recalls based on this factor
What is the severity of the adverse event or risk to patients
What is Five
This class of recall is for products unlikely to cause harm but violate labeling or manufacturing laws
What is class III recalls
Key physical property differentiates a cream from an onintment?
What is water content
Theses oral liquid are clear and hydroalcoholic, meaning they are combinations of water and alcohol, and they are typically flavored
What are elixirs
This document must be approved by the FDA before a company can begin clinical trials on humans
What is an IND, investigational New drug application
This part of the tray is used to pour counted tablets into the vial
What is the dispensing chute
This topical system allows prolonged drug release through the skin
What is a transdermal patch?
The first phase of human testing focuses on this main goal.
What is safety and dosage
Due to the sensitivity of the eye, ophthalmic medications must be free of bacterial contamination?
What is sterile?
This term refers to testing done after approval to monitor long-term safety in the general population?
What is post-marketing surveillance (phase 4)
What should you always do if you are filling a controlled medication
What is count it twice and mark it on the vial label
This FDA program allows healthcare professionals and consumers to report adverse events.
What is MedWatch?
Theses tablets dissolve in the intestines instead of the stomach
What are enteric-coated tablets