<p> 3.04 – Biotechnology Review</p><p>1. Being able to insert a gene for interferon into hamster ovary cells so that the resulting purified drug can be used to treat multiple sclerosis is an example of: a) Biomedical engineering b) Computer engineeering c) Genetic engineering d) Pharmaceutical engineering</p><p>2. Producing an ear of corn that has mixed yellow and white kernels is an example of which type of biotechnology application? a) Agricultural application b) Medical/health care application c) Chemical/environmental application d) Business application</p><p>3. Producing a shampoo that produces less lather for disposal into the water system is an example of which type of biotechnology application? a) Agricultural application b) Medical/health care application c) Chemical/environmental application d) Business application</p><p>4. Developing a quick test for AIDS is an example of which type of biotechnology application? a) Agricultural application b) Medical/health care application c) Chemical/environmental application d) Business application</p><p>5. When Bertie the beagle is examined for the effects of the medication on her hair, this is an example of which step in drug research and development? a) research and development in the lab b) testing in animal models c) human clinical trials d) drug development process</p><p>6. Running computer models to determine which direction the testing process should take for the new drug is an example of which step in drug research and development? a) research and development in the lab b) testing in animal models c) human clinical trials d) drug development process</p><p>7. Marcy has decided to participate in a study for how well Merck's newest GI study drug works. This is an example of which step in drug research and development? a) research and development in the lab b) testing in animal models c) human clinical trials d) drug development process</p><p>8. The average length of time it takes for a drug to make it to market from the initial preclinical testing is: a) 9 years b) 2 years c) 30 days d) 12 years</p><p>9. Which of the following is the first step in drug development? a) research and development in the lab b) testing in animal models c) human clinical trials d) drug development process</p><p>10. Which of the following is the middle step in drug development? a) research and development in the lab b) testing in animal models c) human clinical trials d) drug development process</p><p>11. Which of the following is the last step in drug development? a) research and development in the lab b) testing in animal models c) human clinical trials d) drug development process</p><p>12. The purpose of pre-clinical testing is to: a) test for drug interaction in the human body b) compare new treatment and a placebo c) determine how a drug might affect a live subject (NOT human) d) establish safe boundaries for when human studies begin</p><p>13. This phase of human clinical studies involve the smallest number of people. a) Phase I b) Phase II c) Phase III d) Phase IV</p><p>14. This human clinical phase involves the largest number of people. a) Phase I b) Phase II c) Phase III d) Phase IV</p><p>15. This human clinical phase increases the initial number of human participants. a) Phase I b) Phase II c) Phase III d) Phase IV</p><p>16. The New Drug Application Review is submitted to the FDA at: a) the first idea of a new drug b) midway between phase II and phase III c) once all or most of the proposed studies are completed d) when the company is approved for a patent for the new drug</p><p>17. Phase IV studies of a drug are: a) required for all new drugs b) done using a combination of animals and humans so that drugs can be used in the veterinary field. c) performed to learn more about side effects and long-term risks and benefits. d) done to allow time for the NDA to be submitted electronically since the paperwork is thousands of pages</p><p>18. Separating out the "soup" in the production of pharmaceuticals is which step of the production process? a) synthesis b) purification c) formulation d) final dosage form preparation</p><p>19. Containers are labeled and packaged during which step of the production process? a) synthesis b) purification c) formulation d) final dosage form preparation</p><p>20. Bioreactors may be used during which step of the production process? a) synthesis b) purification c) formulation d) final dosage form preparation</p><p>21. Mixing the active ingredient with the filler is during which step of the production process? a) synthesis b) purification c) formulation d) final dosage form preparation</p><p>22. This step proves proves that a manufacturing process will consistently produce the product to predefined specifications. a) Quality control b) Quality Assurance c) Validation d) Extrapolation</p><p>23. This step requires companies to prepare and follow SOPs by the FDA.</p><p> a) Quality control b) Quality Assurance c) Validation d) Extrapolation</p><p>24. This step is where employees sample and test the raw materials and the product during many stages of the manufacturing process.</p><p> a) Quality control b) Quality Assurance c) Validation d) Extrapolation</p><p>25. When two coworkers analyze the steps they could improve on when producing a quality product, this reflects which of the following? a) Understand customer needs b) Say what you do c) Do what you say d) Prove it</p><p>26. Jennie fills out the log with the materials used to manufacture the product. This is which of the following? a) Understand customer needs b) Say what you do c) Do what you say d) Prove it</p><p>27. Nancy refers to the procedure book to be sure she is following the exact procedures. This is which of the following? a) Understand customer needs b) Say what you do c) Do what you say d) Prove it</p><p>28. When changes are made in the manufacturing process, the manager writes it down so that it is a traceable, written record. This is which of the following? a) Understand customer needs b) Say what you do c) Do what you say d) Prove it</p><p>29. When Mary attends an inservice on how to operate a new piece of equipment she is using demonstrating which of the following employee success skills? a) Manage time b) maintain a safe and orderly work environment c) learning new skills d) follow procedures exactly</p><p>30. Heidi put on the protective suit when handling certain chemicals. She is using demonstrating which of the following employee success skills? a) Manage time b) maintain a safe and orderly work environment c) learning new skills d) follow procedures exactly</p><p>31. Terry reads the standard operating procedures manual to be assured that she completes the procedure correctly. She is using demonstrating which of the following employee success skills? a) Manage time b) maintain a safe and orderly work environment c) learning new skills d) follow procedures exactly 32. Tutti is able to work her station as well as sort new orders at the same time. She is using demonstrating which of the following employee success skills? a) Manage time b) maintain a safe and orderly work environment c) learning new skills d) follow procedures exactly</p><p>33. When Tammy emails all of the management about changes in the manufacturing process, he is using demonstrating which of the following employee success skills? a) Keep precise records b) Communicate effectively c) Work as a team member d) Solve problems, troubleshoot, and improve the process</p><p>34. When Marilyn updates the notebooks to show corrected standard operating procedures, she is using demonstrating which of the following employee success skills? a) Keep precise records b) Communicate effectively c) Work as a team member d) Solve problems, troubleshoot, and improve the process</p><p>35. When Wanda figures out how to increase the speed of the production, she is using demonstrating which of the following employee success skills? a) Keep precise records b) Communicate effectively c) Work as a team member d) Solve problems, troubleshoot, and improve the process 36. Vallerie shares how to set up a "GoTo" meeting on the computer. She is using demonstrating which of the following employee success skills? a) Keep precise records b) Communicate effectively c) Work as a team member d) Solve problems, troubleshoot, and improve the process</p><p>37. What career updates the steps to the occupation manual frequently to maintain the best measures to perform his job? a) quality control associate b) process engineer c) instrumentation technician d) process technician</p><p>38. Sterilizing all materials / equipment in the making of a pharmaceutical is done during which manufacturing step?</p><p>39. “Directions for all pharmaceuticals must be carried out completely” addresses which rule for quality?</p><p>40. Performing maintenance checks on a computer at a biomanufacturing job is an example of what kind of job? a) process engineer b) instrumentation technician c) quality control associate d)process technician 41. Quality assurance ensures ______and ______of pharmaceutical products.</p><p>42. Creating SOP’s for a biopharmaceutical company is part of which career: a) manufacturing support b) research and development c) quality control</p><p>43. ______careers monitor machine problems, including the computerized equipment.</p><p>44. Medication put into labeled bottles is which stage of the production process?</p><p>45. The combination of two ingredients occurs in which step of the manufacturing process?</p><p>46. When removing peanut butter from Reese’s cups you follow a SOP. If removing the Reese’s cup from its packaging is not on the SOP which part of the SOP was left off? a) responsibility b) materials and equipment c) purpose d) procedure</p><p>47. In which part of the SOP does it state who is performing the task described in the SOP? a) responsibility b) purpose c) materials and equipment d) scope</p><p>48. If there are 295 people in a clinical trial, which phase of trials are taking place? FDA review, safety studies, effectiveness, extensive testing</p><p>49. There are 1500 people in a clinical trial. Testing this many people comes under which phase of clinical trials? FDA review, safety studies, effectiveness, extensive testing 50. Which of the following indicates a drug is in phase three of clinical trials? a) 96 participants from 10/2007 – 12/2009 b) 150 participants from 4/2010 – 8/2012 c) 1012 participants from 5/2006 – 6/2010 d) 201 participants from 12/2009 – 5/2012</p><p>51. Phase two clinical trials typically has how many participants?</p><p>52. The application that can create a monitoring system for radiation in water is what type of biotechnology? a) chemical and environmental b) crop c) forest d)medical and healthcare</p><p>53. Over the counter testing for diseases like high cholesterol and HIV are advances in healthcare biotechnology that are examples of what biotechnology applications? a) treating diseases b) diagnosing disease c) enhancing medical applications d) improving animal health</p><p>54. The animal research department is working on a new transgenic animal for better organ transplants. Which part of the animal biotechnology application is it using? </p><p>55. Which biomanufacturing position requires the understanding of infection control and the use of PPE’s? process engineer, process technician, process development scientist ------Key------</p><p>1. (c) </p><p>2. (a) </p><p>3. (c) </p><p>4. (b) </p><p>5. (b) </p><p>6. (a) </p><p>7. (c) </p><p>8. (d) </p><p>9. (a) </p><p>10. (b) </p><p>11. (c) </p><p>12. (d) </p><p>13. (a) </p><p>14. (c) </p><p>15. (b) </p><p>16. (c) </p><p>17. (c) </p><p>18. (b) </p><p>19. (d) </p><p>20. (a) </p><p>21. (c) </p><p>22. (c) </p><p>23. (b) 24. (a) </p><p>25. (a) </p><p>26. (b) </p><p>27. (c) </p><p>28. (c) (d) </p><p>29. (c) </p><p>30. (b) </p><p>31. (d) </p><p>32. (a) </p><p>33. (b) </p><p>34. (a) </p><p>35. (d) </p><p>36. (c)</p><p>37. (a)</p><p>38. synthesis</p><p>39. Do what you say</p><p>40. (b)</p><p>41. effectiveness, safety</p><p>42. quality control</p><p>43. manufacturing support</p><p>44. final dosage form</p><p>45. formulation</p><p>46. (d)</p><p>47. (a)</p><p>48. effectiveness 49. extensive testing</p><p>50. (c)</p><p>51. 100-300</p><p>52. (a)</p><p>53. (b)</p><p>54. enhancing human medical applications</p><p>55. process technician</p>