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, 2020-01-28 20:12 (637 d 15:35 ago) – Posting: # 21092
Views: 4,277

Hi all,

Need some help with running studies in Europe. If I want to run a PK study under each of the two scenarios:

With a drug that is not approved in Europe but approved in USA, and i want to dose at a total daily dose higher than the total daily dose per label in USA.
With a drug that is approved in Europe but at a higher total daily dose than that on the label.

What do I need to file? I know in US I need IND, in Canada I need a full CTA (30 days). what about in Europe? how long?

Thx
J

Complete thread:

EMA: What do I need if I want to run an overdose studyjag009 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 study jag009 2020-02-03 20:23

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