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RegisterANVISA and replicate designs [Regulatives / Guidelines]
Dear d_labes,
Unfortunatly, until the moment, the ANVISA did not show us a specific guideline published and official to explain how we should to proceed with replicate crossover designs.
The RE 898 from 2003 is old and do not follow the advance of bioequivalence studies.
On the other hand, in some non official meetings, in regulatory terms, ANVISA clarified that accept the use of the statistical method for scaling proposed by the European Agency with the exception that for scaling can only be applied in the cases that the intra-subject coefficient of variation (CV%) exceeds 40% for the originator product.
As we do not have a new regulation, each protocol must be previously submitted to the technical evaluation of Therapeutic Equivalence Coordination (Anvisa) before conducting the bioequivalence study that you want to consider the scaling.
There are many view points as you can check in "Anvisa's home brewed scaling" posted by Helmut in this forum. Check it out!
During a plan to bioequivalence study for submission in Brazil, frequently I avoid replicate designs. Why?
Because two reasons:
First, in Brazil we do not have criteria or regulations established and everything can change according a new understanding from ANVISA. Black on white is much better!
Second, according Helmut's post (ANVISA’s home brewed scaling?), if ANVISA wants 40% as the switching condition, a very little gain in terms of the acceptance range could be observed!
Best regards!
Unfortunatly, until the moment, the ANVISA did not show us a specific guideline published and official to explain how we should to proceed with replicate crossover designs.
The RE 898 from 2003 is old and do not follow the advance of bioequivalence studies.
On the other hand, in some non official meetings, in regulatory terms, ANVISA clarified that accept the use of the statistical method for scaling proposed by the European Agency with the exception that for scaling can only be applied in the cases that the intra-subject coefficient of variation (CV%) exceeds 40% for the originator product.
As we do not have a new regulation, each protocol must be previously submitted to the technical evaluation of Therapeutic Equivalence Coordination (Anvisa) before conducting the bioequivalence study that you want to consider the scaling.
There are many view points as you can check in "Anvisa's home brewed scaling" posted by Helmut in this forum. Check it out!
During a plan to bioequivalence study for submission in Brazil, frequently I avoid replicate designs. Why?
Because two reasons:
First, in Brazil we do not have criteria or regulations established and everything can change according a new understanding from ANVISA. Black on white is much better!
Second, according Helmut's post (ANVISA’s home brewed scaling?), if ANVISA wants 40% as the switching condition, a very little gain in terms of the acceptance range could be observed!
Best regards!
Complete thread:
- ANVISA and replicate designs d_labes 2016-05-11 09:47 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ANVISA and replicate designsMauricio Sampaio 2016-05-18 06:14
- ANVISA and replicate designs earlybird 2016-05-19 16:10
- ANVISA = EMA’s ABEL! Helmut 2016-05-19 16:23
- ANVISA = EMA’s ABEL! Lucas 2016-05-19 18:32
- Method A, B (or C?) Helmut 2016-05-19 19:04
- ANVISA = EMA’s ABEL! Mauricio Sampaio 2016-05-19 19:57
- ANVISA = EMA’s ABEL? d_labes 2016-05-24 09:46
- ANVISA = EMA’s ABEL! Lucas 2016-05-19 18:32
- ANVISA = EMA’s ABEL! Helmut 2016-05-19 16:23
Ing. Helmut Schütz