PREPARATION EXAM

BIOTECHNOLOGY

COUNCIL FOR CONTINUING PHARMACEUTICAL EDUCATION CONSEIL DE FORMATION PHARMACEUTIQUE CONTINUE

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A) B) True False 3. 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. 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 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. The use of yeast fermentation in the production of beer is an example of biotechnology.PREPARATION EXAM BIOTECHNOLOGY 1. 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 . In the manufacture of commercial products using micro-organisms.

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. economic. In the production of proteins from the information contained in a gene. 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. environmental and health aspects of biotechnology. focused on biohealth agricultural biotechnology firms are centred in the Prairies aquaculture. scientific. expert panel that arbitrates the regulatory decisions of the federal government on the ethical. social. 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 .6. The Canadian Biotechnology Advisory Committee (CBAC) is an independent. A) B) True False 8. the Biologics and Genetic Therapies Directorate continues to monitor the product through its surveillance and inspection programs. forestry and biodiversity firms are most prevalent in the Atlantic provinces all of the above statements are true 9. Even after a product has received initial marketing approval. regulatory. A) B) True False 7.

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. drugs exclusive patent rights . A) B) True False 12. A) B) True False 15. it can expect to earn about twice as much as it spends.11. 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. 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. Phenotype refers to the biological consequences of a mutation within the sequence of DNA.V.

A) B) True False . In Canada.16. In one type of biotech business model. 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. which of the following biotechnology products may not be patented? A) B) C) D) proteins bacteria surgical methods contraceptive methods 17. Regarding the impact of biotech partnerships. With respect to the factors that favourably influence a biotech’s decision to partner with a large pharma company. a biotech firm develops lead candidates and partners with a commercial partner following Phase I or II. 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. 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. An important incentive for pharma companies to enter into partnerships deals with biotech is the resultant increase in share price for the pharma.

21. 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. 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. 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 . physicians require sufficient knowledge about the use of biopharmaceuticals and the appropriate methods to manage patients. 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. In order for physicians to assist their patients in making informed decisions about the use of biopharmaceuticals. 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 Assisted Human Reproduction Act (Bill C–13). 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. 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. A) B) True False 29.26. the majority of provinces mandate that manufacturers of biopharmaceuticals provide cost-effectiveness studies with their formulary submissions. In addition to clinical trial data. A) B) True False . 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. if passed into law by the federal government of Canada. 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. will permit gestation but will prohibit the selection of babies by gender for non-medical reasons.

D A D B B A B D D C A D A B D Mod. 5 Mod. 4 Mod. p. 17. p. p. p. p. 10. 5. 4. 22. 15 Mod. 4. p. 2. 5 Mod. 15. 3. 25. 5. 10 Mod. 3. 12. C C B D B B C C A A D C A A B Mod. 7 Mod. p. 8 Mod. 1. p. p. 23. 2 Mod. 6 Mod. 7 Mod. p. 13. 5 Mod. 3. 6. p. p. 30. 5. 8 Mod. p. 6. 3. 7 Mod. 4. p. p. 4 Mod. p. 14 Mod. p. 11 Mod. 3. 26. 5 Mod. 7. 4. 19 Mod. p. 29. p. Answer Reference 1.ANSWER KEY FOR PREPARATION EXAM BIOTECHNOLOGY Quest. p. 11 16. 6. 7. 20. p. 8. 18. 5. 28. 4 Mod. 7. 8 . 2. p. 5 Mod. 5 Mod. p. p. 1 Mod. 4 Mod. 1. p. 7 Mod. p. 19. 5 Mod. 1. 27. 2. p. p. 12 Mod. 7. 21. 24. p. 6. 2. 4. 7. 8. 14. Answer Reference Quest. 5. 8 Mod. 3 Mod. 11. p. 1. 9. 6. 2. 8.

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