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NEW QUESTION 51
Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a reimbursement agency?
Answer: A
NEW QUESTION 52
Which of the following BEST describes the content of the "Physical, Chemical, and
Pharmaceutical Properties and Formulation" section of an IB?
instructions for storage and handling of the dosage form: and a description of the formulationD. 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
Answer: C
NEW QUESTION 53
A drug product presents degradation during the manufacturing process. In addition to the amount, what information should be provided FIRST in order to use API overage?
Answer: B
NEW QUESTION 54
Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?
Answer: C
NEW QUESTION 55
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