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 of the following best describes the role of a 'placebo' in a controlled clinical trial?
Answer: An inactive substance used to eliminate bias when comparing treatment effects
A placebo is an inert treatment that controls for the psychological effects of receiving treatment, allowing true drug effects to be isolated.
What is the 'patent cliff' in the pharmaceutical industry?
Answer: The sharp revenue decline a brand drug experiences when its patent expires and generics enter
When a blockbuster drug loses patent protection, generic competitors rapidly erode market share, causing a steep revenue drop known as the patent cliff.
Post-marketing surveillance studies conducted after FDA approval are categorized as:
Answer: Phase IV studies
Phase IV studies occur after a drug is approved and marketed, monitoring long-term safety and effectiveness in the general population.
Which document must a pharmaceutical sales representative provide to a healthcare provider that summarizes FDA-approved prescribing information?
Answer: The Package Insert (PI) / Prescribing Information
The package insert (prescribing information) is the FDA-approved label containing indications, dosing, contraindications, warnings, and clinical data.
The FDA's 'Orphan Drug Act' provides incentives for developing drugs that treat diseases affecting fewer than how many people in the US?
Answer: 200,000
The Orphan Drug Act defines rare diseases as those affecting fewer than 200,000 people in the US and provides tax credits, grants, and 7-year market exclusivity.
In clinical research, what does 'double-blind' mean?
Answer: Neither the patient nor the investigator knows which treatment the patient is receiving
In a double-blind study, both participants and researchers are unaware of treatment assignments, minimizing bias in assessment and reporting.
What is the standard FDA review period for a Priority Review application?
Answer: 6 months
Priority Review reduces the standard 10-month review period to 6 months for drugs offering major advances over available therapies.