What are drugs?
Chemical substances used in treatment, prevention, or diagnosis of a disease
Drugs enhance quality of life.
What are the two main categories of drugs?
- Biologics
- Small molecules
What are biologics?
Larger molecules manufactured by living organisms (plants, bacteria, animals)
Biologics are a category of drugs.
What are small molecules?
Small molecules, some naturally produced by living organisms, mostly manufactured through chemical synthesis.
What is the FDA?
Food and Drug Administration, US based organization
Most drugs not US based seek FDA approval since 50% of their profits come from the US.
What characterizes ethical innovator pharmaceuticals?
Research-based companies that invest heavily, discover, and develop new entities.
What are generic drugs?
Drugs that enter the market after patent expires, do not discover new entities, and are cheaper due to limited research investments.
What must generic drugs maintain compared to the original?
- Same bioavailability
- Same identity
- Same formulation
What is a biotech company?
A company created to make academic discoveries, investing in research and focusing on specialized products.
What are CROs?
Contract Research Organizations that specialize in one thing and are borrowed by pharmaceuticals to make processes faster.
What is the Drug Product Database?
A database containing data on 50,000 products, including licensed products in Canada.
How many new molecular entities are typically approved each year?
35-55 new molecular entities.
What is the difference between a molecular entity and a product?
- Molecular Entity: Pure active ingredient (e.g., acetaminophen)
- Product: Formulation that contains the molecular entity (e.g., Tylenol)
What factors increase the cost to develop a new drug?
New technology adds regulatory requirements, necessitating more research and testing.
What are the typical stages in drug project progression?
- Idea/target identification
- Discovery
- Preclinical development
- Clinical development
- Market and post-market
What happens during the discovery stage of drug development?
Finding and optimizing a lead compound, identifying a Drug Candidate (NME).
What is an Investigational New Drug (IND)?
A drug candidate that has passed preclinical studies and is submitted for clinical trial approval.
What does the NDA process entail?
Review of data from clinical trials to assess safety, benefits vs. risks, and manufacturing reproducibility.
What is an Abbreviated NDA (ANDA)?
A submission for generic drugs to enter the market, requiring proof of same ingredient, dosage, and formulation.
True or False: A drug candidate must have external regulatory approval before beginning preclinical work.
False
Fill in the blank: A drug candidate is synthesized and tested over _______ years.
1-3 years
What is the average duration for filing a New Drug Application (NDA)?
5-7 years
What must be included in an IND submission?
- Toxicity data
- Safety data
- Reliability
- Manufacturing details
- Purity and consistency methods
- Clinical trial plans
