lecture 18 Flashcards
What is the exceptions for Phase 1 study?
Phase study is usually conducted on healthy individuals. However, for anticancer agents and HIV drugs, when it’s first adminitered in human, it is tested on patients rather than healthy individuals
For a drug manufacture to sell drug products in Canada, what are needed to be recieved?
How are they assigned? (what is it based on)
Notice of compliance (NOC), Drug information number (DIN)
NOC is assigned based on the conclusion that drug’s benefits outweigh the risks/harm, and the risks can be managed
How long does each stage in drug development usually take?
Drug discovery and preclinical studies: 3-6 years
Clinical studies: 6-7 years
Regulatory review: 0.5-2 years
Post market surveillance: lifetime of drug
What are four common reasons for drug withdrawal?
Safety issue
Lost of therapeutic interest
Lack of efficacy evidence
Poor market performance
What does the patented medicine prices review board do? What CANT they do?
They regulate the manufacturers prices of patented meidinces sold in Canada, ensuring that they are not excessive
They review the “factory gate’ price of the drug, meaning the price of drug that manufacture sells to wholesalers/ pharmacy/ hospital
They cannot regulate generic drug, or prices charge by wholesalers/ retailers/ pharmacists
What is a NON?
Notice on non-compliance. It is given when the drug submission has failed
What is abbreviated NDS?
It is the NDS submitted by generic drug companies
They do not hve to provide as much information as the manufacturer who obtained the patent
But it must have same safety, efficacy as brand name drug, as well as same quality standards
Information about production, packaging and labelling is required
What is Canada’s drug agenecy? (CDA)
It is created and funded by federal, territorials and provincial governments
It provides information and advice to health care decision makers, informing decisions about optimal use of drugs health technologies
What is contained in NDS (new drug submission)?
It contains the scientific information about the safety, efficacy and quality of the drug, inluding datas from preclinical/ clinical studies, details about drug production, propsed packagaing and labelling, info the support therapeutic value of drug, conditions for use, infor about potential ADR
What is DIN-HM
Homeopathic medicine number
What is NHPs?
Natural health product that are naturally occuring substances, used to restore/ maintain good health
What is NPN vs DIN
DIN= drug identification number, which is required by all drug sold in Canada
NPN= natural health product number, which is assigned by Natural and non-prescription Health product branch
It has a separate regulatory process
What is phase 1 clinical studies? What gender does it bias? What is the target patient? What is the size? What is the main goal?
Phase 1 is the first time a drug being administered in humans. It bias male participants, as female has pregnancy concerns
It targets mostly healthy volunteers, with small number of subjects ( around 100), following controlled inclusion/ exclusions criteria
Main goal is to establish pharmacokinetic parameters, and some examination on drug safety
What is phase 2 study? What is the aim of the study, and who’s the target of study? What is the size? What should be done before giving the drug to target?
Phase 2 is the first time a drug is given to patient, ie individuals with the disease.
It aims to see if the drug does what it is supposed to from a therapeutic perspective, and examine some safety of drug
It follows inclusion exclusion criteria, and it conducted in hundreds of patients
Dosing adjustment for patients has to be done
What is phase 3 study? What is the size of it? What does it do and what is the goals? What is the cost?
Phase 3 is the last stage of clincial study. It involves thousands of patients.
It compare with standard current drug therapy or placebo, aim to examine safety and efficacy
It is still fairly controlled inclusion/exlusion criteria
Very expensive, and usually involved multiple sites
What is Phase 4? What does it focus on? Where does it occur?
It is the post market surveillance of drug, often obervational studies
It focus mostly on drug safety
It takes place in the real world
It is the post market surveillance of drug, often obervational studies
It focus mostly on drug safety
It takes place in the real world
A placebo is a substance or treatment that appears real but has no active therapeutic properties, often used in clinical trials as a control to assess the effectiveness of a new treatment.
What is the drug development process in canada? From the start to the end
What are the numbers on compound in each stage (generally)
What are two factors of consideration?
Drug discovery –> preclinical study (on animail) –> clinical study (in humans) (phase 1, phase 2 , phase 3) –> regulatory review –> post marketing surveillance
Less and less compounds in each stage
Safety and cost
What is the patent act/ patent law?
Manufacturers of brand name drug have a 17 years of patent protection from the day of patent issument, or 20 years from the filing date, whichever expires later
Drug manufacture has exclusive right of the drug, preventing others from selling. making the same drug
What must be conducted before administering drug to humans? ie before submitting clinical trials application
What are included in the practice? What are the goals?
Preclinical testing
Examine sturcture-activity relationship, in bitro assays, animal studies, etc
To examine pharmacokinetic parameters, expected efficacy, ADR, effects in pregnancy, etc
Who are responsible for reviewing and regulating pharmaceutical drugs and medical devices for human use?
What are they primarily looking for?
Pharmceutical drugs directorate (PDD), Health product and food branch(HPFB), Health Canada
They are looking at safety, efficacy and quality
