DETAILED ANSWERS|LATEST UPDATE!!!!!!2026|GUARANTEED
CORRECT = 100
100
INCORRECT=0
STUDY MATERIALS.......DESIGNED TO HELP YOU SUCCEED
1
, SPOTLIGHT 1
DETAILED ANSWERS|LATEST
UPDATE!!!!!!2026|GUARANTEED PASS|GRADED
April 30 1996 - ANSWER ICH GCP Development Date
Quality - ANSWER ICH Q
Efficacy - ANSWER ICH E
Safety - ANSWER ICH S
Multidisciplinary - ANSWER ICH M
guidance for industry, consolidated guideance - ANSWER ICH E 6
Clinical Safety Data Management Definitions and Standards - ANSWER ICH E2A
Safety pharmacology studies for human pharmaceuticals - ANSWER ICH S7A
Electronic records, electronic signatures - ANSWER 21 CFR Part 11
Informed Consent - ANSWER 21 CFR Part 50
2
, Financial Disclosures - ANSWER 21 CFR Part 54
Institutional Review Board - ANSWER 21 CFR Part 56
IND Application - ANSWER 21 CFR 312
New Drug Application - ANSWER 21 CFR 314
Investigational Device Exemption - ANSWER 21 CFR 812
21 CFR Part 814 - ANSWER pre market approval of medical devices
45 CFR Part 46 - ANSWER Federal Research
Studies that investigate the potential undesirable PD effects of a substance on physiological
functions in relation to exposure in the therapeutic range or above - ANSWER Safety
Pharmacology Studies (Pre-Clinical)
1) To Identify undesirable PD properties of a substance that may have relevance to its human
safety.
2) To evaluate adverse PD and/or pathophysio effects of a substance observed in toxicology
studies
3)to investigate the mechanism of the adverse PD effects observed and/or suspected -
ANSWER Drug Development Safety Pharmacology Study Objectives (3)
1) Cardiovascular
2)Respiratory
3
CORRECT = 100
100
INCORRECT=0
STUDY MATERIALS.......DESIGNED TO HELP YOU SUCCEED
1
, SPOTLIGHT 1
DETAILED ANSWERS|LATEST
UPDATE!!!!!!2026|GUARANTEED PASS|GRADED
April 30 1996 - ANSWER ICH GCP Development Date
Quality - ANSWER ICH Q
Efficacy - ANSWER ICH E
Safety - ANSWER ICH S
Multidisciplinary - ANSWER ICH M
guidance for industry, consolidated guideance - ANSWER ICH E 6
Clinical Safety Data Management Definitions and Standards - ANSWER ICH E2A
Safety pharmacology studies for human pharmaceuticals - ANSWER ICH S7A
Electronic records, electronic signatures - ANSWER 21 CFR Part 11
Informed Consent - ANSWER 21 CFR Part 50
2
, Financial Disclosures - ANSWER 21 CFR Part 54
Institutional Review Board - ANSWER 21 CFR Part 56
IND Application - ANSWER 21 CFR 312
New Drug Application - ANSWER 21 CFR 314
Investigational Device Exemption - ANSWER 21 CFR 812
21 CFR Part 814 - ANSWER pre market approval of medical devices
45 CFR Part 46 - ANSWER Federal Research
Studies that investigate the potential undesirable PD effects of a substance on physiological
functions in relation to exposure in the therapeutic range or above - ANSWER Safety
Pharmacology Studies (Pre-Clinical)
1) To Identify undesirable PD properties of a substance that may have relevance to its human
safety.
2) To evaluate adverse PD and/or pathophysio effects of a substance observed in toxicology
studies
3)to investigate the mechanism of the adverse PD effects observed and/or suspected -
ANSWER Drug Development Safety Pharmacology Study Objectives (3)
1) Cardiovascular
2)Respiratory
3
