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NEW QUESTION 42
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?

• A. 100 patients for 12 months
• B. 3.000 total patient exposures
• C. 200 patients for nine months
• D. 500 patients for three months

Answer: A

NEW QUESTION 43
During an audit of a contract manufacturing facility by a potential client, the auditor requested to be left alone in the records room. The records room contains information on all products produced by the contract manufacturer.
Which action is MOST appropriate for the regulatory affairs professional to take?

• A. Allow the auditor access to the room and records due to the current audit.
• B. Deny the auditor access to the room and records due to confidentiality concerns.
• C. Deny the auditor access to the room and retrieve only the requested records.
• D. Allow the auditor accompanied access to the room to retrieve the records.

Answer: D

NEW QUESTION 44
The API used for an approved drug product conforms to international monograph specifications and local pharmacopeia; however, the international monograph specifications of the API will be changing soon. Which is the most appropriate action for the regulatory affairs professional to take FIRST?

• A. Analyze the impact of the international monograph change on the local pharmacopeia.
• B. Confirm that the international monograph change is not related to local pharmacopeia.
• C. Transfer the notice of the upcoming international monograph change to QA for further processing.
• D. Prepare the international monograph change submission first and then prepare the local change when required.

Answer: C

NEW QUESTION 45
Which of the following BEST describes the content of the "Physical, Chemical, and
Pharmaceutical Properties and Formulation" section of an IB?

• A. 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
• B. 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
• C. 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
• D. A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product

Answer: B

NEW QUESTION 46
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 both identification and non-clinical qualification studies concurrently.
• B. Perform either an identification study or a non-clinical qualification study.
• 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.

Answer: C

NEW QUESTION 47
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