Drug Regulation Flashcards
Overview from bench to bedside
Discovery of new molecules –> Patent –> Health Canada (pre-clinical and clinical testing leading to NOC and product monograph)–> CADTH (clinical data and economic data leading to drug coverage recommendation)–> Providers/pharmacies (Generics and dispensing) –> Patients
Key goals of investigative toxicology drug discovery and development
Target selection and hit identification –> Lead identification and optimization –> Non-clinical development –> Clinical development
Patent process (5 steps)
- Get ready to apply: Determine the type of protection needed and determine if the invention is patentable, cost, patent type
- File the application: Prepare the application, provisional or non-provisional, and submit the application with all the required parts, pre-prosecution
- Application prosecution
- Receive your patent: If the requirements are met, you receive a notice of allowance
- Maintain legal protection of your patent: Pay the maintenance fee and check the status (3.5, 7.5, and 11.5 years for utility patent)
Provisional vs Non-provisional application
Provisional application: quick and inexpensive way to establish a filing date that can be claimed in a later non-provisional application. It will not lead to patents by itself; you have 12 months from the provisional filing date to file the non-provisional application.
Non-provisional application: Examined by a patent examiner and may be issued as a patent if requirements are met.
Utility patent
Covers the creation of a new or improved product, process, or machine
What is a notice of compliance
NOC is issued to a manufacturer following the satisfactory review of a submission for a new drug, and signifies compliance with the food and drug regulation
What are the phases of clinical research
The drug-development process will proceed through all phases over many years.
Phase 1: Screening for safety
Phase 2: Establishing the testing protocol
Phase 3: Final testing
Phase 4: Post-approval studies
Describe the number of people involved in each phase of clinical research
1: 0-80
2: 100-300
3: 1000-3000
4: general population
Before pharmaceutical companies start clinical trials, they conduct extensive _______
pre-clinical studies
What are evolving FDA mechanisms for accelerating the clinical trial?
Fast track and goes straight from bench to bedside
What is compassionate use (right to try)? What are the requirements?
Bypasses phases 2 and 3 of the clinical trials
Requirements are constantly evolving. Exact pre-requisites are not exactly clear and may vary from case to case
What is the common stem cell clinic approach
Avoids the clinical trials approval process entirely
Traditional drug discovery versus drug repurposing
Traditional: time-consuming, financially a burden
Drug repurposing: years can be cut down from the typical drug discovery cycle. Abolish the steps needed for FDA approval
How does FDA approval affect drug repurposing? Effects?
Phase I of trials can be eliminated
Saves time, effort, and money.
What are the challenges of data-driven artificial intelligence modeling in modern, computer-aided drug discovery
As model reliability and predictivity increases, data sparsity and variety decrease