Drug Development Process Flashcards
7 cards from real CNPR practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Drug Development Process flashcards as text
Which phase of drug development is specifically designed to determine the Maximum Tolerated Dose (MTD) and optimal dosing schedule?
Answer: Phase I
Phase I trials primarily focus on safety, tolerability, pharmacokinetics, and establishing the MTD, usually in healthy volunteers or in oncology patients.
What is the significance of a drug receiving '505(b)(2)' NDA status?
Answer: It allows the application to rely on published literature or prior FDA findings for safety and efficacy data not generated by the sponsor
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.
During drug development, 'Good Clinical Practice' (GCP) guidelines ensure:
Answer: That clinical trials are conducted ethically, with accurate data and protection of participants' rights
GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human subjects.
A biosimilar differs from a generic drug primarily because:
Answer: Biologics are large, complex molecules that cannot be exactly replicated, so biosimilars must demonstrate no clinically meaningful differences rather than chemical identity
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.
What is 'drug repositioning' (also called drug repurposing)?
Answer: Identifying new therapeutic uses for an existing, already-approved drug
Drug repositioning leverages existing safety data by finding new indications for approved drugs, significantly reducing development time and cost compared to de novo development.
Which regulatory concept requires that drug manufacturers demonstrate their manufacturing processes consistently produce a product meeting its specifications?
Answer: Process Validation
Process validation establishes documented evidence that a manufacturing process consistently produces a product meeting its predetermined specifications and quality attributes.
When a pharmaceutical company files a citizen petition to delay a generic drug's approval, the FDA must respond within:
Answer: 150 days
Under FDAAA, the FDA must respond to citizen petitions submitted to delay generic approvals within 150 days, with the response typically issued just before or alongside the generic approval.