Pharm 100: PPHC Lectures 7 and 8 with Complete Solutions
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Pharm 100: PPHC
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Pharm 100: PPHC
Pharm 100: PPHC Lectures 7 and 8 with Complete Solutions
Pharm 100: PPHC Lectures 7 and 8 with Complete Solutions
Pharm 100: PPHC Lectures 7 and 8 with Complete Solutions
List the eight steps that a drug must pass through to get from discovery to practice. - ANSWER-1. Molecule discovery
...
Pharm 100: PPHC Lectures 7 and 8 with
Complete Solutions
List the eight steps that a drug must pass through to get from discovery to practice. -
ANSWER-1. Molecule discovery
2. Pre-clinical trials (in vitro/in vivo)
3. Phase I, II, and III trials
4. Therapeutic products directorate (Canadian regulation board for drugs)
5. Notice of compliance (give the okay to go ahead)
6. Phase IV clinical trials
7. CDR (common drug review application)
8. Formulary decision (provincial and hospital)
Which steps in drug development are considered "Pre-Market"? - ANSWER-1.
Discovery
2. Pre-Clinical
3. Phase I, II, II
4. Health Canada Submission
5. Notice of Compliance
Which steps in drug development are considered "Post-Market"? - ANSWER-1. CADTH
submission and CDR review
2. Provincial submissions
3. Formulary Listing
4. Phase IV/Post Market Surveillance
5. Patient Expiry/Generic Entry
(during: PMPRB review (drug prices) and pCPA negotiation (increase value for patients
and drug plans))
What are the "five rights" of drug development? - ANSWER-1. Right patient
2. Right drug
3. Right dose
4. Right time
5. Right route
What is CADTH? What are they responsible for? - ANSWER-Canadian Agency for
Drugs and Technologies in Health
Assessment of the value of health technologies through looking at clinical and
economical evidence
, What three main aspects of drug development is Health Canada/Drug Industry
responsible for? - ANSWER-Quality, Safety and Efficacy
What did Section 41(4), Canadian Patent Act (1969) allow for? - ANSWER-The import
(for resale) of patented drugs
What is compulsory licensing?
What were the effects of this is Canada? - ANSWER-When a government allows
someone else to produce a patented product or process without the consent of the
patent owner or plans to use the patent-protected invention itself.
- Allowed for several high volume drugs to immediately introduce generics (i.e. Valium -
Diazepam, and Penbritin - Ampicillin)
- 1970, 52 generics entered the market (steadied to 17-22 over the next couple years)
and patentee firms retaliated and some reduced Canadian R&D
What provincial policies were introduced regarding generics in Canada? What affect did
this have on the brand name companies?
What negotiations were made between industry and goverment? - ANSWER-1.
Instituted a buying mechanism that facilitated generic expansion
2. Assumed legal liability for generic drug related adverse events
Affects:
Brand name companies claimed Canadian policy was taking a toll on them, were
detrimental to shares and worldwide R&D
Agreement:
First: In exchange for a 5% increase (5% -> 10%) in Canadian R&D, the exclusivity
period would be extended to 10 years
Second: compulsory licensing abolished and patent term extended to 20 years
What was the Canadian government rationale for introducing policies promoting
generics? - ANSWER-- Canadian market was less than 2% of world sales, threat not
credible
- There had been large net benefits to the changes
What is a clinical trial or RCT? - ANSWER-A prospectively planned experiment for the
purpose of evaluating potentially beneficial therapies or treatments (usually conducted
under as many controlled conditions as possible so that they provide definitive answers
to well defined questions)
What are the four main reasons we use clinical trials? - ANSWER-1. Best current
methodology to determine what works, and what doesn't work
2. Least potential for bias
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