ERHS 569 Exam 1 Questions & Answers 2024/2025
GLP 10 principles - ANSWERS1. Test facility organization
2. Quality assurance program
ities
4. apparatus, material, reagents
5. test systems
6. test and reference items
7. SOP's
8. performance of the study
9. reporting of study results
10....
GLP 10 principles - ANSWERS1. Test facility organization
2. Quality assurance program
3.facilities
4. apparatus, material, reagents
5. test systems
6. test and reference items
7. SOP's
8. performance of the study
9. reporting of study results
10. storage and retention of records and materials
1902 Biologics Control Act - ANSWERSEnsures purity & safety of serums, vaccines.
-caused by diphtheria epidemic
1906 Pure Food and Drug Act - ANSWERSProhibits the sale and transport of adulterated or mislabeled
food, drinks and drugs.
Prohibits the mislabeling and misbranding of products.
FDA approval of a drug steps - ANSWERS1. preclinical and IND submitted
2. clinical trials phase 1
3. clinical trials phase 2
4. clinical trials phase 3
5. NDA
6. phase 4 trials
, Clinical trials phase I - ANSWERSParticipants: 20-100 can be healthy or people with the disease trying to
treat
Study length: several months
Primary purpose: -determine safety in humans
-figure out dosage (trying out the NOAEL's and LOAEL's)
-best route of administration
-best aim with fewest side effects
70% get past this phase
how much of the drug is measured in the blood after admin?
Phase II Trials - ANSWERSNumber of participants: 100's participants have the disease trying to treat
Study length: several months-2 years
Primary purpose:
-additional safety data
-determine efficacy and side effects
-optimal dose
-best route of administration
-maximize benefits minimize risk
ONLY 33% GET PAST THIS PHASE
Phase III Trials - ANSWERSNumber of participants: 300-3000 people
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