CNPR Drug Development Process 5

Question 1

Which phase of drug development is specifically designed to determine the Maximum Tolerated Dose (MTD) and optimal dosing schedule?

Accepted Answer

Phase I

Answer

Phase I trials primarily focus on safety, tolerability, pharmacokinetics, and establishing the MTD, usually in healthy volunteers or in oncology patients.

Question 2

What is the significance of a drug receiving '505(b)(2)' NDA status?

Accepted Answer

It allows the application to rely on published literature or prior FDA findings for safety and efficacy data not generated by the sponsor

Answer

A 505(b)(2) NDA is a hybrid submission that can reference existing safety/efficacy data from published literature or other approved drugs, reducing development costs.

Question 3

During drug development, 'Good Clinical Practice' (GCP) guidelines ensure:

Accepted Answer

That clinical trials are conducted ethically, with accurate data and protection of participants' rights

Answer

GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human subjects.

Question 4

A biosimilar differs from a generic drug primarily because:

Accepted Answer

Biologics are large, complex molecules that cannot be exactly replicated, so biosimilars must demonstrate no clinically meaningful differences rather than chemical identity

Answer

Unlike small-molecule generics that can achieve exact chemical identity, biologics are complex proteins where slight manufacturing differences make exact duplication impossible, requiring biosimilarity rather than sameness.

Question 5

What is 'drug repositioning' (also called drug repurposing)?

Accepted Answer

Identifying new therapeutic uses for an existing, already-approved drug

Answer

Drug repositioning leverages existing safety data by finding new indications for approved drugs, significantly reducing development time and cost compared to de novo development.

(CNPR) Certified National Pharmaceutical Representative Practice Test

(CNPR) Certified National Pharmaceutical Representative Practice Test

CNPR Drug Development Process 5