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RegisterBE studies for cytotoxic drugs [Design Issues]
How to conduct the Bio-equivalence studies for the generic cytotoxic drugs (cancer drugs). The case if the BE is to be conducted for the cancer drugs the questions are,
1. Study to be conducted on healthy volunteers or patients.
2. What type of study to be conducted like fasting, fed or steady state.
3. what is the right approach for the BE study for EU and US markets.
Thanks in advance.
Edit: Category changed. [Helmut]
1. Study to be conducted on healthy volunteers or patients.
2. What type of study to be conducted like fasting, fed or steady state.
3. what is the right approach for the BE study for EU and US markets.
Thanks in advance.
Edit: Category changed. [Helmut]
Complete thread:
- BE studies for cytotoxic drugskadarusuresh 2010-02-26 07:21
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE studies for cytotoxic drugs ioanam 2010-02-27 23:41
- BE studies for cytotoxic drugs Dr_Dan 2010-03-12 10:51
Ing. Helmut Schütz