A scientific study designed to test a medical intervention in humans is known as
A clinical trial
What drug, marketed in 1937 before safety testing was required, was responsible for the deaths of more than 100 people?
Which of the following laws established that drugs should be acctuately labeled with contents and dosage
Pure Food and Drug Act (1906)
Which of the following is NOT an ethical concertn about placebo-controlled randomized clinical trials?
The placebo may have unknown side effects.
The 1962 Kefauver-Harris ammendments were approved after babies were born with deformities as a result of:
In what year did the FDA begin to require that a new drug be demonstrated to be effective before it could be marketed?
The cost of expensive clinical trials to demonstrate a new drug is effective typcially is paid by
The drug manufacturer seeking FDA approval.
Which phase of the FDA new drug application involves double-blind, placebo controlled trials to demonstrate that it actually works and involves hundreds or thousands of patients?
Javier wants to study the effects on achievement of taking a course in chemistry in the afternoon, rather than in the morning. Two chemistry classes with the same number of students, but different teachers at 8:30AM and 1:00PM, volunteer to participate in the study. A major problem in this study would be
The FDA publication of approved drug products and pharmaceutical-related patents
A drug class that causes a natural biological action to NOT occur is called:
The brand name of a drug:
Identifies the drug as coming from a specific manufacturer
Which statement is true concerning agonists and antagonists
ED50 is a measure of agonist potency
A drug that mimics the effects of a natural chemical in the body is called a
The main responsibility of an IRB is to
Protect the welfare of research participants.
Three basic ethical principles which became the standard for the acceptable conduct of research involving human subjects in the United States, "Resperct for Persons", "Justice" and "Beneficence" are the guiding principles behind the IRB process. In which of the following were these principles first outlined?
The Belmont Report
________ highlighted the vulnerability of institutionalized children as participants in research and concerned the issue of children deliberately infected with the hepatitis virus.
Which of the following is NOT a criteria that the IRB uses to evaluate research proposals?
The political and community reaction to the research topic being studied.
A dose-response curve is:
A tool used to compare the size of the response to the amount of the drug.
NSAIDs work by
blocking production of prostaglandins.
In class we discussed the drug Celebrex. Which is correct about Celebrex?
Celebrex is an antagonist
The FDA reviews an NDA submission to determine the following
Do the drug's benefits outweigh the risks?
If a new drug is proposed to reduce the symptons of depression, a Phase Three clinical study of that new drug should:
Develop a protocol which tests the proposed drug for both efficacy and safety when administered to people who have been diagnosed with depression.
Because of a patent and the rules of the FDA, a drug is marketed under a patent
for less than twenty years
A patent examiner reviews
Whether the drug is useful
The process where some individuals experience complete symptom reduction in the absense of any treatment is known as
The placebo effect.
A firm can commence studying a new drug by giving the drug to human subjects when
The FDA approves an IND and the firm receives approval from the IRB.
Why are some prescription drugs not available as less expensive generic drugs?
The prescribed drug may be a "pioneer" drug and the 20-year patent-protection period may not have expired.
Which of the following defines a molecule?
A chemical substance that results from the combination of two or more atoms.
A chemical reaction
Breaking of old and formation of new chemical bonds that result in a new molecule.
During which phase in the development of pharmaceutical drugs is the drug tested on healthy human volunteers to test for toxicity.
phase I clinical trials
Which one of the following statements best describes the pharmaceutical term "off label"?
Prescribing a drug for a use not approved by the FDA
The patent system of supporting pharmaceutical research has the following consequences:
It leads to higher prices for the most recently discovered drugs.
When Pfizer's patent for Lipitor expires in about a year
Pfizer is anticipated to lose revenue from the exclusitivity provided by its patent even though it can continue to sell artovastation calcium as Lipitor excplusively.
A ____ is a "string" of 100-1000 amino acids joined by peptide bonds
James Johnston has invented a new molecule called Zeta. Zeta is a new, novel and useful drug whose mechanism of action would act as an antagonist against the development of cancerous cells. Zeta may be effective in colorectal cancer, breast cancer and lukemia. The inventor of Zeta is James Johnson. James Johnson as the inventor would be protected as owner of Zeta is:
He would apply for a patent
Newcorp, a California corporation, in order to exploit Zeta, would:
Have Johnson asign the patent to Newcorp.
Johnson, in his research relating to Zeta, also discovered some new scientific information relating to cancer. Johnson would:
Publish an article relating to the science of cancer since science cannot be patented.
A patent on the claim that Zeta would be useful in the treatment of cancer would give Johnson and the assignee the right to
Exclude others from selling Zeta in the United States for cancer.
On the successful completion of Phase 3 trials testing Zeta for efficacy in treating colorectal cancer, and approval by the FDA of the sale of Zeta for that indication:
Newcorp or its licensee could market Zeta only for the indications approved by the FDA.
The value of a patent for a drug
is based on the potential size of the market for its sale, the probability it will be approved for sale, and the time and costs associated with securing FDA approval.
If an invention is novel and non-obvious to an expert who works in the field, that is fufficient to receive a patent from the United States Patent Office. T/F
Potency refers to the degree to which a drug is able to produce maximal effects. T/F
A widely accepted proviso in human research is that the use of placebos is unethical when effective treatments are already available. T/F
The "America Invents Act of 2011", changes patent laws in the United States to shat a patent is issued to the first person to invent a product or process, even though someone else may have been the first to file for the patent. T/F
In a double-blind study, a researcher tests the effectiveness of a medication so that neither the person administering nor the person reveiving the treatment knows whether the subject is in the control or the experimental goup. T/F
One purpose of "random assignment" in a clinical trial is to eliminate bias in treatment assignment such as selection bias and confounding. T/F
It is generally understood that consent to do research on children is not required. T/F
The Hatch-Waxman Amendment to the Food Drug and Cosmetics Act provided a mechanism for the approval of generic drug products. T/F
Approval of an abbreviated new drug application requires review of large clinical studies assessing the effectiveness of the product. T/F