1
Comes from the bark of the Pacific yew tree and interferes with growth capabilities of cancer cells
What is Taxol?
After the IND is submitted to the FDA, the research study is then submitted and approved by _____ before human clinical trials can begin.
What is the Institutional Review Board (IRB)?
The first four or five numbers of an NDC number identifies this
What is the manufacturer or the distributor of the drug?
One way that scientists can demonstrate bioequivalence between brand name and generic drugs
What is bioavailability?
A drug that inhibits growth of leukemia and other cancer cells and comes from the periwinkle plant in the rainforests of Madagascar
What is Vincristine?
A document that states the purpose and risks of the research in easily understandable terms
What is an informed consent form?
What is somatotropin?
This phase of a clinical study evaluates the effectiveness and the safety of a drug for a specific indication or disease state.
What is Phase 2?
Natural substances combined with laboratory substances. Example is amoxicillin
What are semisynthethic drugs?
This phase of a clinical study is the initial study or trial of the new drug. Used to gather data concerning potential side effects and how the drug is metabolized and excreted
What is Phase 1?
A drug that has been created in the laboratory from a series of chemical reactions to produce a specific pharmacological effect. An example is phenobarbital.
What is a synthetic drug?
Laboratory drugs developed to mimic the pharmacological action of the naturally occurring sources. Examples ephedrine and aspirin
What are synthesized drugs?
This phase of a clinical study assesses the overall benefits and risks of the investigational drug on patients.
What is phase 3?
An antibiotic used to treat tuberculosis and comes from the bacterium Streptomyces griseus
What is streptomycin?
The last one or two digits of an NDC number identifies
What is the packaging size and type?
Derived from the use of biotechnology to produce unique drugs with specific therapeutic effects. An example is Humulin insulin.
What are biogenetically engineered drugs?
A pharmaceutical company must do extensive research on animals before they can fill this with the FDA
What is the investigational new drug application (IND)?
A medication for poorly functioning thyroids and is an extract from desiccated pig thyroids
What is Armour Thyroid?
The second 3 or 4 digits of an NDC number identifies
What is the drug (active ingredient and its dosage form)?
These show up in patient, provider, and pharmacy personnel reference materials and highlight dangerous side effects, interactions and use of drugs
What are boxed warnings?
A compound from the horseshoe crab's blue blood that causes clots in the presence of bacterial toxins. It is used to test drugs, vaccines, and surgical implants to ensure that they are germ-free.
What is limulus amebocyte lysate?
If the investigational drug shows promise after phase 3 studies are completed, the pharmaceutical manufacturer can submit _____________ to the FDA.
What is a new drug application (NDA)?
A negative consequence to a patient from taking a particular drug
What is an adverse drug reaction (ADR)?
A generic pharmaceutical company can submit a/n ______ to the FDA once the patent is due to expire on a brand name drug.
What is an abbreviated new drug application?
A centralized database that gathers and stores information from Medwatch and the VAERS
What is the Adverse Event Reporting System (AERS)?