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Hello Helmut!
As always quite enlightening! Thx for the info about the history behind BE, it did not had reached Brazil just yet. Very good information is always welcome.
No, not what I meant. I don't think that you've said that, I meant that the regulators and the creators of the approach stated that.
BTW Dr Laszlo Endrenyi gave us a lecture about that recently in a workshop organized by our company at ANVISA. He said many good things about you in our lunch/dinner breaks.
Do you think that we can assume that outside of EUROPE/USA/etc also? The reason I'm asking it is that it seems to me that in "3rd world countries" (or using the polite way to call countries like mine: developing countries) I'd not be sure about that, due to late developing of regulations (when compared to EU and US).
As always quite enlightening! Thx for the info about the history behind BE, it did not had reached Brazil just yet. Very good information is always welcome.
❝ Not sure whether I wrote that. Are you reading in between the lines?
No, not what I meant. I don't think that you've said that, I meant that the regulators and the creators of the approach stated that.
❝ It would be worthwhile to go back in time when – apart from ABE – prescribability (by population BE) and switchability (by individual BE) was discussed.
BTW Dr Laszlo Endrenyi gave us a lecture about that recently in a workshop organized by our company at ANVISA. He said many good things about you in our lunch/dinner breaks.
❝ The innovator has a database of hundreds–thousands of patients before he gets the approval. If a generic comes in we have a database of millions of patient-years.
Do you think that we can assume that outside of EUROPE/USA/etc also? The reason I'm asking it is that it seems to me that in "3rd world countries" (or using the polite way to call countries like mine: developing countries) I'd not be sure about that, due to late developing of regulations (when compared to EU and US).
Complete thread:
- Article: BE-criteria too strict sometimes? Helmut 2014-09-23 12:39 [BE/BA News]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Article: BE-criteria too strict sometimes? Ohlbe 2014-09-23 22:20
- Risk assessment Helmut 2014-09-24 03:34
- Risk assessment Ohlbe 2014-09-24 10:22
- Risk assessment nobody 2014-09-30 17:59
- Risk assessment Helmut 2014-10-01 13:02
- Risk assessment nobody 2014-10-01 13:32
- Risk assessment Helmut 2014-10-01 13:02
- Risk assessment nobody 2014-09-30 17:59
- Risk assessment Ohlbe 2014-09-24 10:22
- Risk assessment Helmut 2014-09-24 03:34
- Are all men born equal? ElMaestro 2014-09-24 11:20
- Article: BE-criteria too strict sometimes? felipeberlinski 2014-09-24 18:47
- Some animals are more equal than others Helmut 2014-09-24 19:14
- Some animals are more equal than others nobody 2014-09-24 20:32
- Some animals are more equal than others Lucas 2014-10-14 17:02
- Some animals are more equal than others Helmut 2014-10-14 21:15
- Some animals are more equal than othersLucas 2014-10-14 22:25
- Some animals are more equal than others Helmut 2014-10-15 03:20
- Some animals are more equal than othersLucas 2014-10-14 22:25
- Some animals are more equal than others Helmut 2014-10-14 21:15
- Article: BE-criteria too strict sometimes? Ohlbe 2014-09-23 22:20
Ing. Helmut Schütz