Bio batch for Phase 1 [Regulatives / Guidelines]
Good to see you.
I have one question about bio batch.
I already searched about my doubt in this website, but i can't get enough answer, so I write this sentences.
We plan to proceed the Phase 1 IND in US in soon.
So, we will use the CMO for Biobatch.
Pharmaceutical is, Capsule, and Antibiotics.
At this point,
- I wonder if the production scale at the clinical stage can produce only the required quantity for clinical trials.
- (After that), I wonder if production is possible regardless of the scale produced in the clinical trial in the PV batch.
- I wonder if Phase 1 must produce more than 100,000 units.
- If we can produce less than 100,000 units, I wonder if we should produce more than 100,000 units in Phase 2 and 3.
- Also, I wonder what kind of data is needed for the consistency of biobatch to be used in Phase 1 and Phase 2 and 3.
Thank you very much for your help.
- Bio batch for Phase 1 - Kim Christoper, 2018-06-29 10:42 [Regulatives / Guidelines]