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NEW QUESTION 48 According to the ICH guideline on GMP for API, to which of the following is the MOST stringent requirement applied?
- A. Isolation and purification
- B. Introduction of the API starting material
- C. Production of Intermediate(s)
- D. Physical processing and packaging
Answer: D NEW QUESTION 49 Which of the following double-blind clinical trial designs would be MOST appropriate for a Phase III study with a new product intended to treat an acute life-threatening disease with less than optimal available therapy?
- A. Cross-over
- B. Dose-ranging
- C. Active-controlled
- D. Placebo-controlled
Answer: A NEW QUESTION 50 A regulation change is imminent and may require further non-clinical testing on a product currently in Phase III clinical trials. What is the most appropriate action to take FIRST?
- A. Consult with the company's legal department regarding options.
- B. Inform the company's senior management and arrange an emergency meeting
- C. Obtain a copy of the proposed regulation and analyze the impact.
- D. Arrange for additional testing of the product at the testing facility.
Answer: C NEW QUESTION 51 During face-to-face meetings with the regulatory authority to address submission issues, what is the BEST choice for the number of company representatives who should attend?
- A. As many as required by international standards
- B. All senior management from the main office
- C. The minimum number of attendees necessary to address the issues
- D. As many as government attendees
Answer: C NEW QUESTION 52 Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the effect of the patent expiration, which is the BEST action for the company to take?
- A. Conduct a Phase III study for a new unrelated indication of the drug.
- B. Explore litigation strategy for patent infringements on the drug.
- C. Develop a better brand-name drug in the same class.
- D. Develop a generic version of the drug.
Answer: D NEW QUESTION 53 ......