NURS 330: Final Exam with
100% correct answers
Phases of Approval for Therapeutic and Biologic Drugs:
1.) Preclinical investigation
2.) Clinical investigation
3.) Review of the New Drug Application (NDA)
4.) Postmarketing surveillance
Preclinical Investigation:
- Extensive laboratory research
- Scientists perform many tests on human and microbial cells
cultured in the laboratory
- Studies are performed in several species of animals to examine the
drug's effectiveness at different doses and to look for adverse
effects
*Preclinical investigation results are always inconclusive as
laboratory tests do not always reflect the way a human will respond
Clinical Investigation:
- Clinical investigation, the second phase of drug testing, takes
place in three different stages termed clinical trials
- Clinical phase trials are the longest part of the drug approval
process
- Clinical pharmacologists first perform tests on volunteers to
determine proper dosage and to assess for adverse effects
- Large groups of selected patients with the particular disease are
then given the medication
- Clinical investigators from different medical specialties address
concerns such as whether the drug is effective, worsens other
medical conditions, interacts unsafely with existing medications, or
affects one type of patient more than others
, - If a drug appears to be effective without causing serious side
effects, approval for marketing may be accelerated, or the drug may
be used immediately in special cases with careful monitoring
- If the drug shows promise but precautions are noted, the process
is delayed until the pharmaceutical company remedies the concerns
- In any case, a New Drug Application (NDA) must be submitted
before a drug is allowed to proceed to the next phase of the
approval process
- An Investigational New Drug (IND) application may be submitted
for Phase I clinical trials when it is determined that there are
significant therapeutic benefits and that the product is reasonably
safe for initial use in humans
- Companies usually begin developing a trade name for drugs during
Phase I of the IND process
New Drug Application (NDA):
- During this phase, the drug's trade name is finalized.
- If the NDA is approved, the process continues to the final phase
- If the NDA is rejected, the process is suspended until noted
concerns are addressed by the pharmaceutical company
Postmarketing Surveillance:
- The purpose of this phase is to survey for harmful drug effects in a
larger population
- Some adverse effects take longer to appear and are not identified
until a drug is circulated to large numbers of people
Teratogenic Risk:
Classification of teratogenic risk places drugs into categories A, B,
C, D, and X
Category A:
Category A is the safest group of drugs
Category X:
100% correct answers
Phases of Approval for Therapeutic and Biologic Drugs:
1.) Preclinical investigation
2.) Clinical investigation
3.) Review of the New Drug Application (NDA)
4.) Postmarketing surveillance
Preclinical Investigation:
- Extensive laboratory research
- Scientists perform many tests on human and microbial cells
cultured in the laboratory
- Studies are performed in several species of animals to examine the
drug's effectiveness at different doses and to look for adverse
effects
*Preclinical investigation results are always inconclusive as
laboratory tests do not always reflect the way a human will respond
Clinical Investigation:
- Clinical investigation, the second phase of drug testing, takes
place in three different stages termed clinical trials
- Clinical phase trials are the longest part of the drug approval
process
- Clinical pharmacologists first perform tests on volunteers to
determine proper dosage and to assess for adverse effects
- Large groups of selected patients with the particular disease are
then given the medication
- Clinical investigators from different medical specialties address
concerns such as whether the drug is effective, worsens other
medical conditions, interacts unsafely with existing medications, or
affects one type of patient more than others
, - If a drug appears to be effective without causing serious side
effects, approval for marketing may be accelerated, or the drug may
be used immediately in special cases with careful monitoring
- If the drug shows promise but precautions are noted, the process
is delayed until the pharmaceutical company remedies the concerns
- In any case, a New Drug Application (NDA) must be submitted
before a drug is allowed to proceed to the next phase of the
approval process
- An Investigational New Drug (IND) application may be submitted
for Phase I clinical trials when it is determined that there are
significant therapeutic benefits and that the product is reasonably
safe for initial use in humans
- Companies usually begin developing a trade name for drugs during
Phase I of the IND process
New Drug Application (NDA):
- During this phase, the drug's trade name is finalized.
- If the NDA is approved, the process continues to the final phase
- If the NDA is rejected, the process is suspended until noted
concerns are addressed by the pharmaceutical company
Postmarketing Surveillance:
- The purpose of this phase is to survey for harmful drug effects in a
larger population
- Some adverse effects take longer to appear and are not identified
until a drug is circulated to large numbers of people
Teratogenic Risk:
Classification of teratogenic risk places drugs into categories A, B,
C, D, and X
Category A:
Category A is the safest group of drugs
Category X:
