Bad luck [Study Assessment]
Hi Helmut
I meant the final report not the protocol, sorry. I thought that something like clinical pharmacology of the drug may, to some extent, reassure our NCA that safety and efficacy are not at risk?
❝ You can’t change the protocol once the study is done, right?
I meant the final report not the protocol, sorry. I thought that something like clinical pharmacology of the drug may, to some extent, reassure our NCA that safety and efficacy are not at risk?
Complete thread:
- Cmax is out of the range Mikalai 2018-08-01 12:05 [Study Assessment]
- Bad luck Helmut 2018-08-01 13:37
- Bad luckMikalai 2018-08-01 13:50
- Cherry-picking Helmut 2018-08-01 15:01
- Bad luckMikalai 2018-08-01 13:50
- Cmax is out of the range jag009 2018-08-02 17:56
- Bad luck Helmut 2018-08-01 13:37