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NEW QUESTION 27
Which term does NOT describe the same concept as the others?
Answer: A
NEW QUESTION 28
A company is developing a new line of products in an area that is new to the company.
What is the BEST approach?
Answer: C
NEW QUESTION 29
A company is considering the development of a medical device similar to those already available. Which of the following should be evaluated FIRST when developing a clinical evaluation document?
Answer: B
NEW QUESTION 30
The manufacturer of an API was changed from Company X to Company Y during the late stage of a new drug development. Despite differences in the manufacturing processes of the companies, both APIs meet the current specifications. Which is the MOST appropriate information to include in the final submission documents?
Answer: C
NEW QUESTION 31
The safety database for an anti-hypertensive drug consists of the following:
* 461 patients exposed for three months
* 343 patients exposed for six months
* 112 patients exposed for nine months
* 74 patients exposed for 12 months
Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?
Answer: D
NEW QUESTION 32
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