最新なRAPS RAC-US問題集（100題）、真実試験の問題を全部にカバー！

質問 1：
During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.
What should be done in response to identifying the impurity?
A. Perform either an identification study or a non-clinical qualification study.
B. Perform both identification and non-clinical qualification studies concurrently.
C. Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.
D. Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.
正解：C

質問 2：
The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug produced by the company. A consumer reported to the regulatory authority that the tablets have a slightly different color and break easily.
Which of the following actions should the regulatory affairs professional take?
A. Ask that the regulatory authority provide the actual product subject to the complaint.
B. Respond to the regulatory authority that the company will provide copies of the relevant
QC records for batch release.
C. Ask that the regulatory authority provide the batch number printed on the packaging of the affected product.
D. Respond to the regulatory authority that the product subject to the complaint is most likely a counterfeit product.
正解：C

質問 3：
In which section of the ICH Common Technical Document will the overview of clinical data appear?
A. Module 1
B. Module 4
C. Module 2
D. Module 3
正解：C

質問 4：
A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?
A. Plasma pooling
B. Individual plasma donation
C. Plasma fractionation
D. Product distribution
正解：D

質問 5：
A regulatory authority announces an inspection of a regulatory affairs professional's facility during a holiday season when most of the staff Is not available. What is the MOST practical approach to this dilemma?
A. Negotiate with colleagues and the authority to find a better time.
B. Inform the authority that the time is not suitable and request a new time
C. Arrange for an inspection without all intended personnel.
D. Insist that key personnel be available for the inspection.
正解：A

質問 6：
A request was received from a regulatory authority asking the company to conduct product testing in compliance with a newly issued regulation.
What should be done. What action should the company take FIRST?
A. Contact the regulatory authority that issued this request and discuss the requirement.
B. Send a letter back to the regulatory authority indicating why the regulation does not apply to the product.
C. Initiate testing immediately to ensure compliance.
D. Consult with colleagues about the request.
正解：A

質問 7：
Which of the following BEST describes the content of the "Physical, Chemical, and
Pharmaceutical Properties and Formulation" section of an IB?
A. A detailed summary of the physical and chemical properties of the drug product with a signed expert statement addressing the suitability and stability of the formulation for its intended use
B. A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product
C. A review of available data to support the determination of the chemical structure and physical attributes of the drug substance plus batch analysis and stability data for the finished formulation
D. A brief summary of relevant physical, chemical, and pharmaceutical properties:
instructions for storage and handling of the dosage form: and a description of the formulation
正解：D