25 Questions
What is the main difference between drug substance and drug product?
Drug substance contains active drug ingredient, while drug product includes inactive ingredients.
What is the primary role of an IRB in the drug approval process?
To review and approve clinical trial protocols
Which term best describes drugs that have the same active ingredient but may differ in inactive components and appearance?
Pharmaceutical equivalents
What do priority reviews of NDAs aim to do compared to standard reviews?
Expedite the approval process for drugs addressing unmet medical needs
Which stage of drug development involves studies on human subjects to assess safety and efficacy?
Clinical trials
What defines a substance as a drug according to the Food, Drug, and Cosmetic Act (FDCA, 1938)?
Intended for use in the diagnosis, cure, mitigation, or prevention of disease in man or animals
What costs and timescales are associated with drug development and approval processes?
High costs with long timescales
What does a finished dosage form contain?
Both active drug ingredient and inactive ingredients
What is the purpose of the Drug Discovery phase in the drug development process?
To find a promising molecule that could become a drug
What is an important criterion when selecting a target molecule for drug development?
Target molecule's potential to interact with drugs
What is the purpose of preclinical testing in the drug development process?
To ensure that the drug candidate is safe for human testing
What does the Investigational New Drug (IND) application involve?
Requesting FDA authorization to administer an investigational drug to humans
In drug development, what does ADMET stand for?
Absorption, Distribution, Metabolism, Excretion, and Toxicology
What percentage of compounds typically survive the preclinical phase and reach clinical testing?
~0.01%
What happens during the Drug Development phase after identifying a lead compound?
Scaling up production for clinical testing
What is the primary goal of Target Identification in drug development?
To understand the underlying cause of a disease
What is the purpose of an Investigational New Drug (IND)?
To allow clinical testing on humans before approval
Who can submit a Sponsor-Investigator IND?
Physicians
What kind of situation warrants the use of an Emergency Use IND?
Urgent life-threatening medical situations
What is the purpose of an Institutional Review Board (IRB) in clinical trials?
To protect the rights and welfare of participants
In what phase is an Exploratory IND Study (Phase 0) conducted?
Phase I
When does an Investigational New Drug (IND) become effective?
30 days after submission
What is the purpose of a Treatment IND?
To provide promising experimental drugs for grave conditions
Who approves Investigational New Drug (IND) applications at clinical trial sites?
Institutional Review Boards
Under what circumstance might an Emergency Use IND be used?
For urgent life-threatening medical situations.
Explore the drug development and approval process, from preclinical studies to post-marketing surveillance. Learn about drug substances, drug products, IRBs, NDA reviews, and generic drug approval. Understand terms like bioequivalents, pharmaceutical equivalents, and therapeutic.
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