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 regulatory submission allows a pharmaceutical company to begin human clinical trials in the US?
Answer: Investigational New Drug (IND) Application
An IND application must be filed with the FDA and allowed to proceed before any human clinical testing can begin.
What is the primary purpose of a Phase II clinical trial?
Answer: To assess efficacy and further evaluate safety in a larger patient population
Phase II trials enroll patients with the target disease to gather preliminary efficacy data and continue safety evaluation.
The Hatch-Waxman Act (1984) was primarily designed to:
Answer: Facilitate generic drug entry by clarifying patent and data exclusivity rules
Hatch-Waxman created the ANDA pathway and patent challenge mechanisms that allow generic drugs to reach market more quickly after brand exclusivity expires.
In drug development, 'ADME' refers to which four pharmacokinetic processes?
Answer: Absorption, Distribution, Metabolism, Excretion
ADME describes how a drug is absorbed into the body, distributed to tissues, metabolized (chemically transformed), and excreted.
Which FDA designation is granted to drugs targeting serious conditions where the drug demonstrates substantial improvement over available therapies?
Answer: Breakthrough Therapy Designation
Breakthrough Therapy Designation provides intensive FDA guidance and may expedite development for drugs showing early clinical evidence of substantial improvement.
What does 'bioavailability' measure in pharmacokinetics?
Answer: The fraction of an administered dose that reaches systemic circulation unchanged
Bioavailability (F) is the proportion of a drug dose that reaches the systemic circulation and is available to exert its pharmacological effect.
A pharmaceutical company discovers a promising compound in the lab. What is the NEXT step before animal studies can begin?
Answer: Conducting preclinical in vitro testing
After discovery, compounds undergo in vitro (cell and biochemical) testing before progressing to animal (in vivo) preclinical studies.