Pharma Interactions - Beardsley Flashcards
•Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its ___, determine a ___ ___ range, and identify __ __
Phase II: The drug or treatment is given to a ___ group of people to see if it is __ and to further evaluate its ___
Phase III: The drug or treatment is given to ___ groups of people to confirm its effectiveness, monitor __ ___, ___ it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
•Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with __-__ use.
•Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
•Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.
Phase I;
- Purpose: __ and __
- During Phase 1 studies, researchers test a new drug in normal volunteers (healthy people). In most cases, __ to ___ healthy volunteers or people with the disease/condition participate in Phase 1. However, if a new drug is intended for use in cancer patients, researchers conduct Phase 1 studies in patients with that type of cancer.
- Phase 1 studies are closely monitored and gather information about how a drug ___ with the human body. Researchers adjust dosing schemes based on animal data to find out how much of a drug the body can ___ and what its acute __ __ are.
- As a Phase 1 trial continues, researchers answer research questions related to how it works in the body, the side effects associated with increased __, and early information about how effective it is to determine how best to administer the drug to limit risks and maximize possible benefits. This is important to the design of ___ studies
Phase I:
- Purpose: Safety and dosage
- During Phase 1 studies, researchers test a new drug in normal volunteers (healthy people). In most cases, 20 to 80 healthy volunteers or people with the disease/condition participate in Phase 1. However, if a new drug is intended for use in cancer patients, researchers conduct Phase 1 studies in patients with that type of cancer.
- Phase 1 studies are closely monitored and gather information about how a drug interacts with the human body. Researchers adjust dosing schemes based on animal data to find out how much of a drug the body can tolerate and what its acute side effects are.
- As a Phase 1 trial continues, researchers answer research questions related to how it works in the body, the side effects associated with increased dosage, and early information about how effective it is to determine how best to administer the drug to limit risks and maximize possible benefits. This is important to the design of Phase 2 studies
Phase 2:
- Purpose: __ and __ __
- In Phase 2 studies, researchers administer the drug to a group of patients with the disease or condition for which the drug is being developed. Typically involving a few ___ patients, these studies aren’t ____ enough to show whether the drug will be ___.
- Instead, Phase 2 studies provide researchers with additional ___ data. Researchers use these data to refine research ___, develop research ___, and design new __ research protocols.
- Purpose: Efficacy and side effects
- In Phase 2 studies, researchers administer the drug to a group of patients with the disease or condition for which the drug is being developed. Typically involving a few hundred patients, these studies aren’t large enough to show whether the drug will be beneficial.
- Instead, Phase 2 studies provide researchers with additional safety data. Researchers use these data to refine research questions, develop research methods, and design new Phase 3 research protocols.
Phase 3
- Purpose: __ and monitering __ __
- Researchers design Phase 3 studies to demonstrate whether or not a product offers a ___ benefit to a specific population. Sometimes known as pivotal studies, these studies involve 300 to 3,000 participants.
- Phase 3 studies provide most of the ___ data. In previous studies, it is possible that less common side effects might have gone ___. Because these studies are __ and __ in duration, the results are more likely to show___ __ or ___ side effects.
Gets the drug on the market!
- Purpose: Efficacy and monitoring of adverse reactions
- Researchers design Phase 3 studies to demonstrate whether or not a product offers a treatment benefit to a specific population. Sometimes known as pivotal studies, these studies involve 300 to 3,000 participants.
- Phase 3 studies provide most of the safety data. In previous studies, it is possible that less common side effects might have gone undetected. Because these studies are larger and longer in duration, the results are more likely to show long-term or rare side effects
Gets the drug on the market!
Phase 4
- Purpose: __ and __
- Phase 4 trials are carried out once the drug or device has been approved by ___ during the Post-Market Safety Monitoring
- Purpose: Safety and efficacy
- Phase 4 trials are carried out once the drug or device has been approved by FDA during the Post-Market Safety Monitoring
What does the FDA Approves?
- ____– what the drug is approved to be used for
- ____ effecs that have to be mentioned
- Any special monitoring programs
- Wording for the “package insert”
- Keeping the discussion of the medication to what the FDA approved is being “___ ____”
What does the FDA Approves?
•Indications – what the drug is approved to be used for
•Adverse effects that have to be mentioned
- Any special monitoring programs
- Wording for the “package insert”
- Keeping the discussion of the medication to what the FDA approved is being “on label”
