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Question # 1
According to ICH, which of the following components of study information is NOT required
in a clinical study report?
A. Randomization scheme and codes
B. Protocol and protocol amendments
C. ListoflECsorlRBs
D. Detailed CVofall investigators
Question # 2
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?
A. The process information and analytical result of Company X API
B. The process information and analytical result of Company Y API
C. The process information and the comparative analytical result of APIs from both companies
D. Information deemed appropriate by the regulatory authority
Question # 3
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 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
C. A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product
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
Question # 4
As part of the regulatory strategy for companies intending to manufacture a psychotropic
product, which of the following approvals should be received FIRST?
A. Site license
B. Product license
C. Import license
D. Export license
Question # 5
What are the MOST important elements that global regulatory agencies want to know
before approving a new product for sale in their countries?
A. Safety and failure risk
B. Safety and effectiveness
C. Quality and failure risk
D. Quality and effectiveness
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