Chapter 3: Strength For The U.S. Economy Flashcards
Pharmaceutical companies are generally either research based or focused on the manufacturing of generic drugs. True or false?
True.
What companies are the leading edge innovators?
Research based companies.
Pharmaceutical companies that develop novel drugs are known as ethical pharmaceutical companies. True or false?
True.
What companies employ the most sales representatives?
Research based pharmaceutical companies.
What is research and development?
This focuses on discovering new chemicals and molecules, and turning them into safe and effective pharmaceutical products.
What is manufacturing and operations?
This is the supply chain, manufacturing, trade, and distribution functions of the business.
What is marketing and sales?
This communicates the benefits of the companies pharmaceutical products and creates demand for those products.
What is one of the most significant results of the industries continued investment in R&D?
The large number of new drugs approved and in development.
Internationally how many new drugs are expected to be approved every year?
Over 100 new drugs.
What is PhRMA?
Pharmaceutical Research and Manufacturers of America.
What is liver cirrhosis?
Chronic liver damage leading to scarring and liver failure.
The field of personalize medicine includes what?
Patients unique molecular and genetic profiles.
What is the sixth leading cause of death in the US?
Alzheimer’s disease.
How many new medicines are in development for cancer?
3,070 new medicines.
What disease causes progressive neurodegeneration, that leads to paralysis and death?
Lou Gehrig’s disease also known as ALS.
How many new diabetes medicines are in development?
281 new diabetes medicines.
How many medicines are currently in development for HIV/AIDS?
185 new medicines.
Someone newly diagnosed with HIV is expected to live an additional 50 years with new medications. True or false?
True.
Why is the American pharmaceutical industry a major part of the American economy?
Because of a significant investment in R&D.
The pharmaceutical industry has grown twice as fast as the overall economy in the last few decades. True or false?
True.
The pharmaceutical industry is one of the key drivers of economic growth. True or false?
True.
The pharmaceutical industry employs how many people?
Over 650,000 people directly. 4 million jobs indirectly in other sectors.
Since 1890 the average lifespan of an American has increased by how many years?
Nearly 30 years.
What is an approvable letter?
Letter sent by the FDA to the applicants, indicating whether the new drug application (NDA) or abbreviated new drug application (ANDA) for a product substantially meets the necessary requirements.
What is a NDA?
New drug application.
What is an ANDA?
Abbreviated new drug application.
What is asymptomatic?
Without signs or symptoms of disease.
What is a blinded or masked study?
A study in which participants do not know whether they are in the experimental or control group in a research study.
What is a control or control group?
The standard, by which experimental observations are evaluated. Control groups are commonly given a placebo.
What is a double blind or double mask study?
This is a study in which neither the participants nor the study staff know which participants are receiving the experimental treatment, and which patients are in the control group.
What is edema?
Swelling.
What are fast track drugs?
Fast track approval is provided for drugs that meet medical needs for patients with serious or life-threatening conditions.
What is indication?
In terms of drug approval, the exact caused or purpose for which the FDA has approved that a drug can be prescribed.
What is the institutional review board (IRB)?
A committee of physicians, statisticians, community advocates, and others which ensures that a clinical trial is ethical and the rights of the study participants are protected.
All clinical trials in the US must be approved by the IRB.
What is off label?
Usage of a medication for purposes, other than the specific ones appearing in the labeling.
What is a placebo?
A placebo is an inactive substance that has no treatment value.
In clinical trials experimental treatments are compared with placebos to assess the effectiveness.
What is the placebo effect?
The effect produced by a placebo due to the expectations of the patient.
What is study protocol?
The general design, an operating features of a trial.
What is toxicity?
The extent quality or degree to which a substance is poisonous or harmful to the body.
What is a treatment group?
A group of patients assigned to receive a specified treatment.
