13. Clinical research protocols include:
Anonymous Quiz
3%
A) Sales data
5%
B) Recipe of the drug
90%
C) Study design, objectives, endpoints
2%
D) Cleaning procedures
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14. Which document is required for marketing approval of a new drug in the US?
Anonymous Quiz
15%
A) IND
30%
B) ANDA
50%
C) NDA
5%
D) CEP
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15. Role of biostatistics in regulatory submissions is to:
Anonymous Quiz
4%
A) Draw chemical structures
8%
B) Predict market share
84%
C) Analyze and interpret clinical data
4%
D) Conduct safety audits
16. The Drug Development Team (DDT) typically includes:
Anonymous Quiz
1%
A) Politicians
4%
B) Pharmacists only
94%
C) Multidisciplinary professionals like chemists, toxicologists, and clinicians
1%
D) Only legal advisors
17. Which study phase primarily assesses drug safety in healthy volunteers?
Anonymous Quiz
19%
A) Phase II
25%
B) Phase III
48%
C) Phase I
8%
D) Phase IV
18. Clinical trials conducted after the drug is marketed are:
Anonymous Quiz
5%
A) Phase I
9%
B) Phase II
68%
C) Phase IV
18%
D) Preclinical
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19. What is the purpose of an IND amendment?
Anonymous Quiz
3%
A) Withdraw product
6%
B) Increase cost
80%
C) Notify changes in protocol or safety info
10%
D) Launch product
20. Which is NOT a function of the Regulatory Affairs department?
Anonymous Quiz
6%
A) Regulatory submissions
12%
B) Compliance with guidelines
70%
C) Financial investment planning
13%
D) Responding to regulatory queries
21. ANDA stands for:
Anonymous Quiz
7%
A) Approved NDA
4%
B) Annual NDA
88%
C) Abbreviated New Drug Application
1%
D) Advanced NDA
22. Clinical Data submitted to FDA must follow:
Anonymous Quiz
27%
A) CDSCO format
17%
B) ICH Q7 format
55%
C) Common Technical Document (CTD) format
1%
D) Marketing format
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Forwarded from GPAT/NIPER study point
Antiepileptic drugs pharmacology(1).PDF
9.1 MB
Antiepileptic drugs pharmacology(1).PDF
Forwarded from Amit
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6 MB
SEDATIVE & HYPNOTIC DRUGS .pdf
anticoagulant, fibrinolytics, anti-platelet drugs.pdf
9.9 MB
anticoagulant, fibrinolytics, anti-platelet drugs.pdf
Forwarded from GPAT/NIPER study point
Antiepileptic drugs pharmacology(1).PDF
9.1 MB
Antiepileptic drugs pharmacology(1).PDF
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