Drug Development And Control Flashcards
(23 cards)
What is the first stage of a new drug compound development?
Synthesis/discovery of a new drug compound
This stage includes preliminary studies.
What does Stage 2 of a new drug compound involve?
Safety/effectiveness evaluation
This includes preclinical studies and clinical trials.
What are the key activities in Stage 3 of a new drug compound?
Submission and review of the new drug
This involves review by Health Canada/VDD and approval or rejection based on clinical trial data.
What is the focus of Stage 4 in the development of a new drug compound?
Post-marketing surveillance stage
This includes product monitoring for safety and effectiveness.
What must be approved by Health Canada during the post-marketing surveillance stage?
Any changes in labelling
A new application is required for such changes.
Fill in the blank: The second stage of a new drug compound development includes _______ studies.
clinical trials
True or False: The review of a new drug is conducted by Health Canada.
True
What is evaluated during Stage 2 of drug development?
Safety and effectiveness
This stage includes both preclinical and clinical studies.
List the four stages of a new drug compound development.
- Synthesis/discovery
- Safety/effectiveness evaluation
- Submission and review
- Post-marketing surveillance
What is the difference between a preliminary study and a preclinical study?
Preliminary study is conducted in a lab on computer or bacterial models, while preclinical study is conducted on lab animals, commonly mice.
Preliminary studies often utilize computational or in vitro methods, whereas preclinical studies focus on in vivo testing.
What is the difference between a preclinical study and a clinical trial?
Preclinical studies test on lab animals for safety, toxicity, and reactions, while clinical trials are conducted on target species for safety and effectiveness.
Clinical trials involve human participants or target species to evaluate drug responses in real-world conditions.
Define carcinogenicity.
Ability of a drug to cause cancer.
Carcinogenicity is a critical factor in drug development and regulatory approval.
Define teratogenicity.
Ability of a drug to cause birth defects and/or embryo deaths.
Teratogenicity is assessed during drug testing to ensure safety for pregnant individuals.
How long does a company have to monitor a drug after it has been released?
As long as it is manufactured
Ongoing monitoring is crucial for ensuring drug safety throughout its lifecycle.
Why are both short term and long term testing important?
Short term testing for safety & efficacy: monitor hours after a dose for ADRs
Long term testing for safety & efficacy: run 3-24 months, repeated dosing, for organ function & any other toxic effects
ADRs refer to Adverse Drug Reactions, which are critical to assess during drug testing.
What special tests are performed to assess new drugs?
Toxicity evaluations
ED50 / LD50
ED50 is the effective dose for 50% of the population, while LD50 is the lethal dose for 50% of the population.
Define ED50
Amount of a drug (dosage) that produces a desired effect in 50% of the animals that receive it
Define LD50
Amount of a drug (dosage) that is lethal in 50% of the animals that receive it
What is a therapeutic index?
Margin of safety determined during short term toxicity phase
How is the therapeutic index calculated?
LD50 divided by ED50
What does a higher therapeutic index indicate?
Wider margin of safety
What are systems-oriented screens?
Tests particular effects of a specific system using blood, tissue, urine samples etc.
What is the next step after toxicity study?
Perform systems-oriented screens
