Bioequivalence and Bioavailability Forum 06:53 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Bio batch for Phase 1 [Regulatives / Guidelines]

posted by Kim Christoper - Korea, 2018-06-29 10:42  - Posting: # 18994
Views: 421

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.

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,882 posts in 4,026 threads, 1,271 registered users;
online 18 (0 registered, 18 guests [including 17 identified bots]).

Some scientists claim that hydrogen, because it is so plentiful,
is the basic building block of the universe.
I dispute that. I say there is more stupidity than hydrogen,
and that is the basic building block of the universe.    Frank Zappa

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed