Pharmacy Practice Ch. 3: Drug and Supplement Development

Because nonprescription drugs and supplements are not considered as potent, potentially dangerous, or addictive, the FDA does require?

An intensive approval process

What is the function of vaccines?

To produce immunity to disease

What is commonly prescribed to control HIV?

Combination therapy involving 3-4 drugs

What are some naturally sourced drugs?

Quinine, Vinicristine, and Armour Thyroid

What is the advantage of the semisynthetic drug amoxicillin over the natural-source drug penicillin?

More effective against penicillin-resistant organisms

What drug is produced using DNA technology?

Humulin

What is the purpose of pharmacodynamics agents?

To alter body functioning

What is a type of hormone therapy?

Estrogen, insulin, progesterone

Before a pharmaceutical company can proceed with human trials on a new drug therapy, it must submit a(n)?

IND to the FDA

Why is the generic drug application submitted to the FDA called "abbreviated "?

It only needs to prove bioequivalence

Why does the FDA require OTC product labeling to list active and inactive ingredients?

prevent allergic reactions

What agency is responsible to monitor for the deceptive advertising of dietary supplements?

Federal Trade Commission

Risk Evaluation and Mitigation Strategies (REMS) must be developed by a drug manufacturer when?

The benefit of using a high-risk drug outweighs the adverse effects in certain patient populations

In the IND application, the developer of a new drug must not only provide the data results of animal studies but explain?

How the drug will be manufactured, detailed description of the proposed clinical studies in humans, and why the drug is needed in humans

Antigen

A toxin introduced into the body—sometimes to produce immunity to a specific disease

immunity

Bodily processes that provide protection against disease

septic

infected with bacteria

destructive agents

Works to kill specific living elements such as bacteria, fungi, viruses, or abnormal cancer cells

Bactericidal agents

They kill rather than inhibit bacteria that are sensitive to these drugs

antinoplastic drugs

Use toxins to poison cancer cells

Bioavailability

The time it takes the generic drug to reach the bloodstream in healthy volunteers and exert the targeted pharmacological effect.

Pharmacogenomics

the study of how genetic inheritance affects the body's response to drugs

What happens after INDA has been submitted and Phase 3 studies have been successfully completed?

The drug manufacturer can submit an NDA to the FDA

What does the labeler code (first 4 or 5 digits) of the National Drug Code (NDC) number identify?

The manufacturer or distributer

What drug opened the way for greater research in the effects of drugs on the brain's cognitive, emotional, and social functioning?

Chloropromazine

The discovery of DNA has led to the science of?

Biotechnology

Small group of healthy volunteers used in a trial to gather data on the drug's actions and potential side effects on humans?

Phase 1

Under what conditions might the FDA approve a prescription drug be marketed as an over-the-counter medication?

Safe track record

On what list must the ingredients in a homeopathic drug be listed?

HPUS

Who has the power to recall or pull a drug off the market?

FDA

If a drug had a possibility of an ADR, this information must be included in the?

Product package insert's black box & patient's information print-out

The adverse effects of drugs reported to the MedWatch program and the Vaccine Adverse Reporting System are stored in the?

AERS database

Why should the new drug Addyi (flibanserin) not be mixed with alcohol?

It could cause low blood pressure

antibody

Product of the immune system that identifies and neutralizes foreign substances in the body

Penicillin

Discovered by Alexander Fleming in 1928

The first antiviral drug to treat HIV

FDA approved in 1987

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