EMA: What do I need if I want to run an overdose study [Regulatives / Guidelines]
Hi all,
Need some help with running studies in Europe. If I want to run a PK study under each of the two scenarios:
Thx
J
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.
Thx
J
Complete thread:
- EMA: What do I need if I want to run an overdose studyjag009 2020-01-28 20:12
- 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
- Can of worms ElMaestro 2020-01-30 15:12
- Can of worms Helmut 2020-01-30 13:32
- EMA: What do I need if I want to run an overdose study jag009 2020-01-30 04:32
- 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
- EMA: What do I need if I want to run an overdose study Helmut 2020-01-29 16:52