During the review of a design dossier, the reviewer asks why the company has only carried out a top-down risk approach. The reviewer is referring to which of the following?

• A.Fault tree analysis
• B.Failure mode and effect analysis
• C.ISO 14971 risk analysis
• D.Hazard and operability study

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Which term does NOT describe the same concept as the others?

• A.Subsequent entry biologics
• B.Monoclonal antibody
• C.Biosimilars
• D.Follow-on protein products

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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.Placebo-controlled
• B.Cross-over
• C.Dose-ranging
• D.Active-controlled

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A process is ultimately validated to ensure which of the following?

• A.The process meets the regulatory requirements.
• B.The process meets the quality system requirements.
• C.The process consistently meets the desired Quantity standards
• D.The process consistently produces the desired results.

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Why is it necessary to run supplemental safety pharmacology studies?

• A.To provide adverse reaction reports and the results of the statistical data to the regulatory authority
• B.To substitute the utilization of GLP
• C.To evaluate potential adverse pharmacodynamics effects not addressed by the core battery
• D.To comply with regulatory authority requirements related to clinical studies

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