Hello, I am looking for some help with some toxicology study guide questions 7.

Question

Hello, I am looking for some help with some toxicology study guide questions

7. The _____________ assay measures activity of the repolarizing potassium channel that regulates ventricular heart rate.

A) calcium channel activity

B) sodium channel activity

C) Ames

D) hERG

8. The ICH defines _____________ as " as those studies that investigate the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above."

A) toxicology

B) safety pharmacology

C) pharmacology

D) pre-clinical trials

9. Metabolite profiling studies are often used to:

A) Identify non-human animal model species for toxicity testing

B) Identify the metabolic pathway of the NCE

C) Determine whether induction is taking place

10. Before human clinical trials can begin, the FDA must approve a company’s:

A) Investigational New Drug application

B) Request for Drug Marketing application

C) New Drug Approval application

D) All of the above

11. A New Drug Application (NDA) is filed after Phase ____ clinical trials.

A) I

B) II

C) III

D) IV

12. Post-approval monitoring is also called:

A) Phase 1

B) Phase 2

C) Phase 3

D) Phase 4

E) Phase 5

13. In vivo toxicology studies must be performed following:

A) Good manufacturing processes (GMP)

B) Good clinical practices (GCP)

C) Good laboratory practices (GLP)

D) All of the above

Explanation / Answer

7. D) hERG is a gene which codes for a protein (the alpha subunit of potassium ion channel)

8. B) safety pharmacology

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