Bio batch for Phase 1 [Regulatives / Guidelines]
Dear, Mr. Helmut.
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,
Thank you very much for your help.
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.
Complete thread:
- Bio batch for Phase 1Kim Christoper 2018-06-29 10:42 [Regulatives / Guidelines]