Each clinician must generate a 2-page report,
(NO MORE THAN 2 PAGES AND NO LESS THAN
2 PAGES) for their respective key element.
Therefore, the total should be 6 pages
• 1.5 Line Spacing
• Cambria Font
• 12 Point
• 1” Margins Around
You do not want to just answer the questions but write more than just and each section should be two pages
DRUG NAME: CRESTOR
Group Project
- One individual in each group will present a summary on one of the following topics for their drug:
- CMC Considerations
o What assays are used to set Drug Substance and/or Drug Product Specifications?
- What assays are used to assess in vivo efficacy, pharmacokinetics?
- Where is it manufactured? o Who manufactures the DS? DP?
- Who manufactures the generics?
- Preclinical Efficacy Studies
o How was efficacy assessed?
- What animal models were used to assess efficacy?
- How far up the “food chain” did the company evaluate efficacy before moving to humans?
- What GLP studies were conducted to assess toxicity?
- Pivotal Phase 3 Clinical Study Findings
o What was the design of the Phase 3 program? o How many patients were enrolled?
- Were multiple clinical sites used and if so, were any international sites utilized o Were there any PREA requirements after approval?
- Any other postmarketing recommendations or requirements o Was expedited review and approval granted?
