Exam 2: Stages Of Drug Development III - IND, Clinical Trials Flashcards
What is not associated with the first clinical trial on the effects of certain chemicals on human health?
A) The group of volunteer trial participants are known as the Poison squad
B) Findings contributed to passage of the Pure Food and Drug Act of 1906
C) Substances tested were used as food preservatives
D) Safety of chemicals were not tested in animals prior to humans
E) Trial was supervised by Dr. Kefauver Harris
E) Trial was supervised by Dr. Kefauver Harris
What was the first law that required drug developers to inform the FDA before conducting tests of yet unapproved drugs in human subjects?
A) Pure Foods and Drug Act of 1906
B) Kefauver-Harris Amendments to FFDCA in 1962
C) Biologics Control Act of 1902
D) Drug Importation Act of 1848
E) Hatch-Waxman Act of 1984
B) Kefauver-Harris Amendments to FFDCA in 1962
What is not true of an Investigational New Drug Application?
A) After IND filing to the FDA, there is normally a 30 day wait period before a trial sponsor can commence a clinical trial
B) IND requirements are found in CFR21 Part 312
C) IND approval will allow legal movement of unapproved drugs between states and into the US
D) An IND application is submitted by the trial sponsor
E) IND application is also known as FDA form 820
E) IND application is also known as FDA form 820
An IND is not filed to:
A) Test a new chemical entity in phase I human clinical trials
B) Enable the marketing of an unapproved drug in the 50 states
C) Test an already approved drug for a different indication in humans
D) Declare a change in a designated clinical trial investigator
E) Propose a change to a clinical trial protocol from double blind to open label
B) Enable the marketing of an unapproved drug in the 50 states
An IND submission to the FDA requires information in 3 major areas. What information is not included in those 3 areas?
A) Manufacturing process for both active pharmaceutical ingredient and final drug product
B) Design of the clinical trials in humans
C) Animal pharmacokinetics, i.e., drug absorption, distribution, metabolism and excretion in test animals
D) Chemical structure of the active pharmaceutical ingredients
E) Evidence of adequate training and qualification of field sales agents
E) Evidence of adequate training and qualification of field sales agents
An IND submission to the FDA requires information in 3 major areas. What information is not included in those 3 areas?
A) Manufacturing process for both active pharmaceutical ingredient and final drug product
B) Design of the clinical trials in humans
C) Animal pharmacokinetics, i.e., drug absorption, distribution, metabolism and excretion in test animals
D) Chemical structure of the active pharmaceutical ingredients
E) Evidence of adequate training and qualification of field sales agents
E) Evidence of adequate training and qualification of field sales agents
An IND includes details on the plan for clinical testing. What information may not appear in the study plan for clinical testing?
A) Qualifications of clinical investigators
B) A sound rationale for conducting the tests in humans
C) Professions of the trial participants
D) Description of possible risks to subjects and strategies for protection of subjects
E) Commitment to obtain informed consent from subjects
C) Professions of the trial participants
What would be the most complete definition of clinical trial?
A) any study in which a drug is administered to one or more human subjects to determine if the drug is tolerated by humans
B) any scientific study in which a drug is administered to one human subject to determine how the drug works in a person
C) any scientific study in which a drug is administered to more than one human subject to determine how the drug works in people
D) any scientific study in which a drug is administered to one or more animals to determine how the drug works in non-humans
E) any scientific study in which a drug is administered to one or more human subjects to determine how the drug works in people
E) any scientific study in which a drug is administered to one or more human subjects to determine how the drug works in people
One objective of clinical trials is to determine what the body does to the drug or pharmacokinetics. What is not part of pharmacokinetics?
A) If the active ingredient is mostly being excreted by the kidents such that the amount absorbed is not enough to be effective
B) How effective the drug is in shrinking the size of a cancerous tumor
C) How much of the drug is absorbed by the gastrointestinal tract, by the lungs for inhalable aerosols, or by the skin for topicals
D) How effectively the drug is distributed to target cells or tissues, like a brain cancer drug effectively reaching the brain.
E) If the active ingredient of the drug is being broken down by the liver to inactive or toxic forms
B) How effective the drug is in shrinking the size of a cancerous tumor
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?
A) Parallel double-blind design
B) Parallel blinded design
C) Single group design
D) Randomized open design
E) Parallel open-label design
B) Parallel blinded design
What does not apply to the different phases of clinical trials?
A) In Phase I clinical trials, the safety or toxicity of the drug is mainly tested in a small group of normally healthy individuals
B) 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.
C) In phase III trials is where the maximum tolerated dose of an investigational drug is determined
D) A phase IV study is sometimes conducted to demonstrate possible superiority against a competitor drug
C) In phase III trials is where the maximum tolerated dose of an investigational drug is determined
CFR21 Part 50 on The Protection of Human Subjects was written directly in response to:
A) New York Times expose on unethical syphilis experiments in Tuskegee Clinic in Alabama
B) Deformities that occurred as a result of the morning sickness drug, Thalidomide.
C) The Nazi war criminal trials on unethical science experiments in Nuremberg, Germany
D) Death of children from the use of antifreeze ingredient used as sweetener in antibiotic sulfanilamide elixir
E) World Medical Associations Declaration of Helsinki
A) New York Times expose on unethical syphilis experiments in Tuskegee Clinic in Alabama
What is true about ICH?
A) GCP guidelines are covered under ICH E6
B) Organized to expose drug manufacturing practices that are non-compliant with regulations
C) ICH is an organization tasked to prosecute violations of GLP regulations by drug manufacturers
D) GCP guidelines are covered under ICH Q6
E) ICH favors delaying the introduction of new drug products into the global marketplace
A) GCP guidelines are covered under ICH E6
What applies to informed consent?
A) An informed consent is required even when participants are in life threatening situations
B) Participants are informed that their health may or may not improve as a result of participating in the trial
C) A process by which a subject is coerced to participate in a particular trial after being informed of all aspects of the trial
D) Participants are prevented from being negatively influenced by family members
E) The informed consent should always be communicated to participants in English
B) Participants are informed that their health may or may not improve as a result of participating in the trial
What is not one of the principles of GCP according to ICH guidelines?
A) Possible benefits of trial participation must greatly outweigh the risks to a patients health
B) Records must be accurate, maintained, and kept confidential
C) Clinical trial supplies must have been manufactured according to cGMP regulations
D) Investigators should deviate from the FDA-approved clinical trial protocol
E) Clinical study design must be scientifically and statistically sound
D) Investigators should deviate from the FDA-approved clinical trial protocol
