Define the drug research pathway for Australian drugs to make application to the TGA for approval.
Focus on ALL:
2/. animal trials
3/. human trials across:
i/. Phase 0
ii/. Phase 1
iii/. Phase 2a
iv/. Phase 2b
v/. Phase 3
vi/. Phase 4
Look at costs and time to complete.
Compare, table and graph increase of costs and time over the past 2 decades
As costs and time to complete have significant increased, find references to substantiate WHY?
See attached for initial references, especially MAFACTSBOOK which offers thorough analysis of Australian preceptive.