Bio batch for Phase 1 [Regulatives / Guidelines]

posted by Kim Christoper – Korea, 2018-06-29 10:42  – Posting: # 18994
Views: 530

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,
  1. I wonder if the production scale at the clinical stage can produce only the required quantity for clinical trials.

  2. (After that), I wonder if production is possible regardless of the scale produced in the clinical trial in the PV batch.

  3. I wonder if Phase 1 must produce more than 100,000 units.

  4. 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.

  5. 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.

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