biotech_e
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PREPARATION EXAM
BIOTECHNOLOGY
COUNCIL FOR CONTINUING PHARMACEUTICAL EDUCATION CONSEIL DE FORMATION PHARMACEUTIQUE CONTINUE
3489 ASHBY, ST-LAURENT, QC H4R 2K3 TEL: (1-888) 333-8362 - FAX: (514) 333-1119 WEBSITE: www.ccpe-cfpc.com
PREPARATION EXAM BIOTECHNOLOGY
1.
Some of the advances that biotechnology has contributed to modern life include: A) B) C) D) improved methods to clean up hazardous environmental waste applications to consume less energy DNA fingerprinting all of the above
2.
The use of yeast fermentation in the production of beer is an example of biotechnology. A) B) True False
3.
In the manufacture of commercial products using micro-organisms, the term downstream processing refers to the: A) B) C) D) fermentation of the organism multiplication of the organism preparation of the organism and its food source purification and concentration of the product
4.
Which of the following is not considered to be a biopharmaceutical? A) B) C) D) a recombinant protein human insulin purified from tissue a genetically engineered vaccine a monoclonal antibody
5.
The Biologics and Genetic Therapies Directorate does not have responsibility over which of the following? A) B) C) D) blood biopesticides radiopharmaceuticals viral and bacterial vaccines
6.
Even after a product has received initial marketing approval, the Biologics and Genetic Therapies Directorate continues to monitor the product through its surveillance and inspection programs. A) B) True False
7.
The Canadian Biotechnology Advisory Committee (CBAC) is an independent, expert panel that arbitrates the regulatory decisions of the federal government on the ethical, social, economic, scientific, regulatory, environmental and health aspects of biotechnology. A) B) True False
8.
Which of the following statements regarding the distribution of biotechnology in Canada is true? A) B) C) D) together Quebec and Ontario hold approximately 60% of biotechnology firms, focused on biohealth agricultural biotechnology firms are centred in the Prairies aquaculture, forestry and biodiversity firms are most prevalent in the Atlantic provinces all of the above statements are true
9.
In the production of proteins from the information contained in a gene, translation refers to the: A) B) C) D) modification of a newly synthesized strand of RNA creation of a complementary strand of RNA from DNA transport of RNA out of the nucleus into the cytoplasm of the cell creation of a protein from a strand of RNA
10. Which of the following statements is true? A) B) C) D) Genetics is the study of the functions and interactions of all genes on the genome Genomics refers to the study of single genes and their effects Comparative genomics is the study of gene content and the order of genes on the chromosome none of the above statements is true
11. Phenotype refers to the biological consequences of a mutation within the sequence of DNA. A) B) True False
12. Which of the following statements regarding recombinant DNA technology is false? A) B) C) D) restriction endonucleases are used to cut a strand of DNA at specific sites a vector is a DNA molecule which can replicate independently within a host cell DNA ligase is an enzyme which joins two DNA molecules together “transformation” is a technique used to prevent a host cell from taking up unwanted DNA
13. Which of the following is not a key challenge faced by biotechnology companies? A) B) C) D) attracting academics and scientists obtaining regulatory approvals designing trials that are in compliance with Good Clinical Practice implementing Good Manufacturing Practices
14. Once a biotech firm has evolved to the stage of a “public” company, it can expect to earn about twice as much as it spends. A) B) True False
15. Which of the following does not slow the time it takes for a biological agent to reach the market? A) B) C) D) lengthy provincial reimbursement approvals lack of manufacturing capacity lack of systems to administer I.V. drugs exclusive patent rights
16. In Canada, which of the following biotechnology products may not be patented? A) B) C) D) proteins bacteria surgical methods contraceptive methods
17. With respect to the factors that favourably influence a biotech’s decision to partner with a large pharma company, which of the following pairs of statements are incorrectly matched? A) B) C) D) research/discovery – solo investigator may not have knowledge to proceed with commercialization Phase I/II – biotech company needs cash infusions to stay afloat Phase IV – near full value of investment potential is realized and biotech may wish to capitalize on partner’s marketing skills all of the listed pairs are correctly matched
18. In one type of biotech business model, a biotech firm develops lead candidates and partners with a commercial partner following Phase I or II. This type of business model is called: A) B) C) D) an early-stage collaboration a late-stage collaboration a virtual integrated model a full discovery and development model
19. Regarding the impact of biotech partnerships, which of the following is a challenge faced by the pharma sales force? A) B) C) D) the inability to meet demand for the product failure to appreciate reimbursement issues under-estimation of the size and cost of the sales force all of the above are challenges faced by the sales force
20. An important incentive for pharma companies to enter into partnerships deals with biotech is the resultant increase in share price for the pharma. A) B) True False
21. Pharmacogenomics is the study of: A) B) C) D) methods to change the body’s response to drugs the ways in which an individual’s genetic makeup affects the body’ response to drugs the DNA sequences that code for drug receptor sites methods to increase the drug’s effect
22. The ability to predict how an individual might respond to the effects of a drug is especially important for which of the following types of drugs? A) B) C) D) drugs that require tests of serum drug levels to ensure appropriate dosing drugs with side effects that are expensive to manage both A and B neither A nor B
23. The process of making molecules which interact with potentially new drug targets is called: A) B) C) D) proteomics bioinformatics combinatorial chemistry high throughput screening
24. Which of the following does not represent a useful route for the administration of biopharmaceutical agents? A) B) C) D) oral subcutaneous intravenous intramuscular
25. In order for physicians to assist their patients in making informed decisions about the use of biopharmaceuticals, physicians require sufficient knowledge about the use of biopharmaceuticals and the appropriate methods to manage patients. Which of the following does not represent a useful method to provide continuing education on biopharmaceuticals? A) B) C) D) training on reimbursement assistance development of clinical guidelines enrolment of physicians in special access programs participation in safety monitoring protocols
26. Which of the following statements regarding drug reimbursement is true? A) when a treatment or medical service is administered by a publicly funded hospital during a hospital admission, its cost is typically reimbursed by the provincial drug plan when a treatment is administered to outpatients at a specialized treatment clinic within the hospital, the cost of the drug is reimbursed by the hospital both A and B are true neither A nor B is true
B) C) D)
27. Which of the following factors determines whether drug reimbursement is provided by provincial or private drug plans? A) B) C) D) route of drug administration the cost associated with drug administration medical necessity of the treatment the need for medical supervision during the drug’s administration
28. In addition to clinical trial data, the majority of provinces mandate that manufacturers of biopharmaceuticals provide cost-effectiveness studies with their formulary submissions. A) B) True False
29. Which of the following statements concerning the Convention on Bioethics and Medicine is true? A) B) C) D) it bans all forms of discrimination based on a person’s genetic makeup it bans all predictive genetic test it bans all forms of genetic engineering in humans all of the above statements are true
30. The Assisted Human Reproduction Act (Bill C–13), if passed into law by the federal government of Canada, will permit gestation but will prohibit the selection of babies by gender for non-medical reasons. A) B) True False
ANSWER KEY FOR PREPARATION EXAM BIOTECHNOLOGY
Quest.
Answer
Reference
Quest.
Answer
Reference
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15.
D A D B B A B D D C A D A B D
Mod. 1, p. 2 Mod. 1, p. 5 Mod. 1, p. 5 Mod. 1, p. 7 Mod. 2, p. 5 Mod. 2, p. 5 Mod. 2, p. 5 Mod. 2, p. 7 Mod. 3, p. 4 Mod. 3, p. 7 Mod. 3, p. 8 Mod. 3, p. 11 Mod. 4, p. 3 Mod. 4, p. 4 Mod. 4, p. 11
16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30.
C C B D B B C C A A D C A A B
Mod. 4, p. 14 Mod. 5, p. 8 Mod. 5, p. 12 Mod. 5, p. 19 Mod. 5, p. 15 Mod. 6, p. 1 Mod. 6, p. 5 Mod. 6, p. 5 Mod. 6, p. 6 Mod. 7, p. 4 Mod. 7, p. 7 Mod. 7, p. 8 Mod. 7, p. 10 Mod. 8, p. 4 Mod. 8, p. 8
BIOTECHNOLOGY
COUNCIL FOR CONTINUING PHARMACEUTICAL EDUCATION CONSEIL DE FORMATION PHARMACEUTIQUE CONTINUE
3489 ASHBY, ST-LAURENT, QC H4R 2K3 TEL: (1-888) 333-8362 - FAX: (514) 333-1119 WEBSITE: www.ccpe-cfpc.com
PREPARATION EXAM BIOTECHNOLOGY
1.
Some of the advances that biotechnology has contributed to modern life include: A) B) C) D) improved methods to clean up hazardous environmental waste applications to consume less energy DNA fingerprinting all of the above
2.
The use of yeast fermentation in the production of beer is an example of biotechnology. A) B) True False
3.
In the manufacture of commercial products using micro-organisms, the term downstream processing refers to the: A) B) C) D) fermentation of the organism multiplication of the organism preparation of the organism and its food source purification and concentration of the product
4.
Which of the following is not considered to be a biopharmaceutical? A) B) C) D) a recombinant protein human insulin purified from tissue a genetically engineered vaccine a monoclonal antibody
5.
The Biologics and Genetic Therapies Directorate does not have responsibility over which of the following? A) B) C) D) blood biopesticides radiopharmaceuticals viral and bacterial vaccines
6.
Even after a product has received initial marketing approval, the Biologics and Genetic Therapies Directorate continues to monitor the product through its surveillance and inspection programs. A) B) True False
7.
The Canadian Biotechnology Advisory Committee (CBAC) is an independent, expert panel that arbitrates the regulatory decisions of the federal government on the ethical, social, economic, scientific, regulatory, environmental and health aspects of biotechnology. A) B) True False
8.
Which of the following statements regarding the distribution of biotechnology in Canada is true? A) B) C) D) together Quebec and Ontario hold approximately 60% of biotechnology firms, focused on biohealth agricultural biotechnology firms are centred in the Prairies aquaculture, forestry and biodiversity firms are most prevalent in the Atlantic provinces all of the above statements are true
9.
In the production of proteins from the information contained in a gene, translation refers to the: A) B) C) D) modification of a newly synthesized strand of RNA creation of a complementary strand of RNA from DNA transport of RNA out of the nucleus into the cytoplasm of the cell creation of a protein from a strand of RNA
10. Which of the following statements is true? A) B) C) D) Genetics is the study of the functions and interactions of all genes on the genome Genomics refers to the study of single genes and their effects Comparative genomics is the study of gene content and the order of genes on the chromosome none of the above statements is true
11. Phenotype refers to the biological consequences of a mutation within the sequence of DNA. A) B) True False
12. Which of the following statements regarding recombinant DNA technology is false? A) B) C) D) restriction endonucleases are used to cut a strand of DNA at specific sites a vector is a DNA molecule which can replicate independently within a host cell DNA ligase is an enzyme which joins two DNA molecules together “transformation” is a technique used to prevent a host cell from taking up unwanted DNA
13. Which of the following is not a key challenge faced by biotechnology companies? A) B) C) D) attracting academics and scientists obtaining regulatory approvals designing trials that are in compliance with Good Clinical Practice implementing Good Manufacturing Practices
14. Once a biotech firm has evolved to the stage of a “public” company, it can expect to earn about twice as much as it spends. A) B) True False
15. Which of the following does not slow the time it takes for a biological agent to reach the market? A) B) C) D) lengthy provincial reimbursement approvals lack of manufacturing capacity lack of systems to administer I.V. drugs exclusive patent rights
16. In Canada, which of the following biotechnology products may not be patented? A) B) C) D) proteins bacteria surgical methods contraceptive methods
17. With respect to the factors that favourably influence a biotech’s decision to partner with a large pharma company, which of the following pairs of statements are incorrectly matched? A) B) C) D) research/discovery – solo investigator may not have knowledge to proceed with commercialization Phase I/II – biotech company needs cash infusions to stay afloat Phase IV – near full value of investment potential is realized and biotech may wish to capitalize on partner’s marketing skills all of the listed pairs are correctly matched
18. In one type of biotech business model, a biotech firm develops lead candidates and partners with a commercial partner following Phase I or II. This type of business model is called: A) B) C) D) an early-stage collaboration a late-stage collaboration a virtual integrated model a full discovery and development model
19. Regarding the impact of biotech partnerships, which of the following is a challenge faced by the pharma sales force? A) B) C) D) the inability to meet demand for the product failure to appreciate reimbursement issues under-estimation of the size and cost of the sales force all of the above are challenges faced by the sales force
20. An important incentive for pharma companies to enter into partnerships deals with biotech is the resultant increase in share price for the pharma. A) B) True False
21. Pharmacogenomics is the study of: A) B) C) D) methods to change the body’s response to drugs the ways in which an individual’s genetic makeup affects the body’ response to drugs the DNA sequences that code for drug receptor sites methods to increase the drug’s effect
22. The ability to predict how an individual might respond to the effects of a drug is especially important for which of the following types of drugs? A) B) C) D) drugs that require tests of serum drug levels to ensure appropriate dosing drugs with side effects that are expensive to manage both A and B neither A nor B
23. The process of making molecules which interact with potentially new drug targets is called: A) B) C) D) proteomics bioinformatics combinatorial chemistry high throughput screening
24. Which of the following does not represent a useful route for the administration of biopharmaceutical agents? A) B) C) D) oral subcutaneous intravenous intramuscular
25. In order for physicians to assist their patients in making informed decisions about the use of biopharmaceuticals, physicians require sufficient knowledge about the use of biopharmaceuticals and the appropriate methods to manage patients. Which of the following does not represent a useful method to provide continuing education on biopharmaceuticals? A) B) C) D) training on reimbursement assistance development of clinical guidelines enrolment of physicians in special access programs participation in safety monitoring protocols
26. Which of the following statements regarding drug reimbursement is true? A) when a treatment or medical service is administered by a publicly funded hospital during a hospital admission, its cost is typically reimbursed by the provincial drug plan when a treatment is administered to outpatients at a specialized treatment clinic within the hospital, the cost of the drug is reimbursed by the hospital both A and B are true neither A nor B is true
B) C) D)
27. Which of the following factors determines whether drug reimbursement is provided by provincial or private drug plans? A) B) C) D) route of drug administration the cost associated with drug administration medical necessity of the treatment the need for medical supervision during the drug’s administration
28. In addition to clinical trial data, the majority of provinces mandate that manufacturers of biopharmaceuticals provide cost-effectiveness studies with their formulary submissions. A) B) True False
29. Which of the following statements concerning the Convention on Bioethics and Medicine is true? A) B) C) D) it bans all forms of discrimination based on a person’s genetic makeup it bans all predictive genetic test it bans all forms of genetic engineering in humans all of the above statements are true
30. The Assisted Human Reproduction Act (Bill C–13), if passed into law by the federal government of Canada, will permit gestation but will prohibit the selection of babies by gender for non-medical reasons. A) B) True False
ANSWER KEY FOR PREPARATION EXAM BIOTECHNOLOGY
Quest.
Answer
Reference
Quest.
Answer
Reference
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15.
D A D B B A B D D C A D A B D
Mod. 1, p. 2 Mod. 1, p. 5 Mod. 1, p. 5 Mod. 1, p. 7 Mod. 2, p. 5 Mod. 2, p. 5 Mod. 2, p. 5 Mod. 2, p. 7 Mod. 3, p. 4 Mod. 3, p. 7 Mod. 3, p. 8 Mod. 3, p. 11 Mod. 4, p. 3 Mod. 4, p. 4 Mod. 4, p. 11
16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30.
C C B D B B C C A A D C A A B
Mod. 4, p. 14 Mod. 5, p. 8 Mod. 5, p. 12 Mod. 5, p. 19 Mod. 5, p. 15 Mod. 6, p. 1 Mod. 6, p. 5 Mod. 6, p. 5 Mod. 6, p. 6 Mod. 7, p. 4 Mod. 7, p. 7 Mod. 7, p. 8 Mod. 7, p. 10 Mod. 8, p. 4 Mod. 8, p. 8
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