BTEC 3317 Quiz 8

What is not associated with the first "clinical trial" on the effects of certain chemicals on human health?

Findings contributed to passage of the Pure Food and Drug Act of 1906

The clinical investigation was not supervised by a licensed physician

The safety of the food preservatives were not tested in animals prior to testing in humans

Led to a law which prohibited interstate transport of unapproved drugs

The clinical investigation was not supervised by a licensed physician

3 multiple choice options

What was the first law that required drug developers to demonstrate by way of clinical trials, that an investigational drug is both safe and effective in humans subjects prior to marketing approval?

Hatch-Waxman Act of 1984

Biologics Control Act of 1902

Kefauver-Harris Amendments to FFDCA in 1962

Pure Foods and Drug Act of 1906

Kefauver-Harris Amendments to FFDCA in 1962

3 multiple choice options

What is not true of an Investigational New Drug Application?

IND approval will allow legal movement of unapproved drugs between states and into the US

IND requirements are found in CFR21 Part 312

After IND filing to the FDA, there is normally a 60 day wait period before the clinical trial can start

IND application is also known as FDA form 1571

After IND filing to the FDA, there is normally a 60 day wait period before the clinical trial can start

3 multiple choice options

An IND is not filed to:

Inform the FDA of a change in the location of an animal testing site.

Test a drug with a previously approved active pharmaceutical ingredient but in a new dosage form

Test a drug with a previously approved active pharmaceutical ingredient but in a higher strength formulation

Test a drug with an new active pharmaceutical ingredient in phase I human clinical trials

Inform the FDA of a change in the location of an animal testing site.

3 multiple choice options

An IND submission to the FDA may not be required if:

An approved breast cancer drug will be tested for ability to treat liver cancer

A once a day, higher strength of an approved gastric efflux drug will be tested

An intravenous formulation of a drug will be tested in an oral dosage form

An individual decides to test if Ivermectin will protect himself from coronavirus, when the drug is not approved for coronavirus treatment.

An individual decides to test if Ivermectin will protect himself from coronavirus, when the drug is not approved for coronavirus treatment.

3 multiple choice options

An IND submission to the FDA requires information in 3 major areas. What information is not included in those 3 areas?

Study protocol for clinical testing in human subjects

Chemical description of the drug, the manufacturing process, and controls

Pre-clinical animal toxicity results

Proposed label and packaging information and design

Proposed label and packaging information and design

3 multiple choice options

An IND includes details on the plan for clinical testing. What information may not appear in the study plan for clinical testing?

Description of possible risks to subjects and strategies for protection of subjects

A science-based justification for testing in humans

Qualifications of clinical investigators

Professions of the test subjects

Professions of the test subjects

3 multiple choice options

One objective of clinical trials is to determine what the body does to the drug or pharmacokinetics. What is not part of pharmacokinetics?

If the active ingredient of the drug is being broken down in the liver to less active or even toxic forms

How effectively the drug is distributed to target cells or tissues, like a brain cancer drug effectively reaching the brain.

If the active ingredient is mostly being excreted such that the amount absorbed is not enough to be effective

How much elevation in activity in liver enzymes is observed when taking the investigational drug

How much elevation in activity in liver enzymes is observed when taking the investigational drug

3 multiple choice options

In which trial design are patients assigned to 2 treatment groups where the details of who among the patients get the investigational drug and who gets the placebo are known to the clinical investigator but not to the trial participants?

Parallel double-blind design

Randomized open design

Parallel open-label design

Parallel blinded design

Parallel blinded design

3 multiple choice options

What does not apply to the different phases of clinical trials?

In phase III trials is where the maximum tolerated dose of an investigational drug is determined

In Phase I clinical trials, the safety or toxicity of the drug is mainly tested in a small group of normally healthy individuals

A phase IV study is sometimes conducted to demonstrate possible superiority against a competitor drug

In Phase II of clinical trials, the efficacy and safety of the investigational drug is normally first tested in individuals (up to a few hundreds) who have the condition being treated.

In phase III trials is where the maximum tolerated dose of an investigational drug is determined

3 multiple choice options

CFR21 Part 50 on The Protection of Human Subjects' was written directly in response to:

World Medical Association's Declaration of Helsinki

Deformities that occurred as a result of the morning sickness drug, Thalidomide.

New York Times expose on unethical syphilis experiments in Tuskegee Clinic in Alabama

Death of children from the use of antifreeze ingredient used as sweetener in antibiotic sulfanilamide elixir

New York Times expose on unethical syphilis experiments in Tuskegee Clinic in Alabama

3 multiple choice options

What is true about ICH?

Organized to expose drug manufacturing practices that are non-compliant with regulations

GCP guidelines are covered under ICH Q6

GCP guidelines are covered under ICH E6

ICH is an organization tasked to prosecute violations of GLP regulations by drug manufacturers

GCP guidelines are covered under ICH E6

3 multiple choice options

What applies to informed consent?

Participants are prevented from being negatively influenced by family members

A process by which a subject is coerced to participate in a particular trial after being informed of all aspects of the trial

An informed consent is required even when participants are in life threatening situations

Participants are informed that their health may or may not improve as a result of participating in the trial

Participants are informed that their health may or may not improve as a result of participating in the trial

3 multiple choice options

What is not one of the principles of GCP according to ICH guidelines?

Investigators should routinely deviate from the FDA-approved clinical trial protocol

Possible benefits of trial participation must greatly outweigh the risks to a patients health

Clinical trial supplies must meet Good Manufacturing Practices standard

Clinical trial supplies must have been manufactured according to cGMP regulations

Investigators should routinely deviate from the FDA-approved clinical trial protocol

3 multiple choice options

What is not meant to be answered by conducting clinical trials?

Does the investigational drug treat, cure, or provide relief for a particular condition?

What are the harmful effects of the investigational drug on humans?

Does the investigational drug improve the skill and dexterity of investigators?

What happens to the investigational drug upon administration to humans?

Does the investigational drug improve the skill and dexterity of investigators?

3 multiple choice options