Bioequivalence and Bioavailability Forum • EMA: What do I need if I want to run an overdose study

EMA: What do I need if I want to run an overdose study [Regulatives / Guidelines]

posted by jag009 – NJ, 2020-02-03 21:23 (1704 d 12:12 ago) – Posting: # 21133
Views: 4,471

Thanks Ohlbe!

❝ When I read your post I interpreted it differently than Helmut and ElMaestro. So could you clarify your question: would you run those studies to register your drug in Europe, or to register it in the USA ? Helmut and ElMaestro answered with EU registration in mind, I understood you were asking about the authorisation of the studies.

Purely a exploratory study for the interest of science. No registration no drug submission. The drug is marketed in US (IR + ER), IR is available all over the world.

❝ Being based in the USA, you would need a legal representative in the EU.

Agree.

❝ You will need to justify in your protocol (subject safety) and plan the monitoring of the subjects accordingly.

Yes the protocol will implement a lot of medical monitoring, blood chemistry testing, etc. Subjects will be housed in clinic for the entire study.

Thx
J

Complete thread:

EMA: What do I need if I want to run an overdose study jag009 2020-01-28 20:12 [Regulatives / Guidelines]
- EMA: What do I need if I want to run an overdose study Helmut 2020-01-29 16:52
  - EMA: What do I need if I want to run an overdose study jag009 2020-01-30 04:32
    - Can of worms Helmut 2020-01-30 13:32
      - Can of worms ElMaestro 2020-01-30 15:12
        
        Can of worms jag009 2020-02-03 20:28
      - Can of worms jag009 2020-02-03 20:34
- EMA: What do I need if I want to run an overdose study Ohlbe 2020-01-30 17:32
  - EMA: What do I need if I want to run an overdose studyjag009 2020-02-03 20:23