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Registerclinical trials/ BE studies for locally acting drugs [Regulatives / Guidelines]
thank you for your response.
as per US FDA guidlines we have to conduct two BE studies both in fasting and fed conditions for sulfasalazine.
but we are in ambiguity to show BE for this molecule.
for docusate sodium, it is a solution in soft gelatin capsuls, as per the EMEA guidlines on locally acting liquids we may go for biowaivers.
as per US FDA guidlines we have to conduct two BE studies both in fasting and fed conditions for sulfasalazine.
but we are in ambiguity to show BE for this molecule.
for docusate sodium, it is a solution in soft gelatin capsuls, as per the EMEA guidlines on locally acting liquids we may go for biowaivers.
Complete thread:
- clinical trials/ BE studies for locally acting drugs jagankm 2012-01-25 11:26
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- clinical trials/ BE studies for locally acting drugs drgunasakaran1 2012-01-31 18:42
- clinical trials/ BE studies for locally acting drugs Ohlbe 2012-01-31 19:01
- clinical trials/ BE studies for locally acting drugsjagankm 2012-02-06 12:00
- clinical trials/ BE studies for locally acting drugs Tina 2013-09-16 18:10
- clinical trials/ BE studies for locally acting drugsjagankm 2012-02-06 12:00
- clinical trials/ BE studies for locally acting drugs Tina 2013-09-19 09:45
- clinical trials/ BE studies for locally acting drugs Ohlbe 2012-01-31 19:01
- clinical trials/ BE studies for locally acting drugs drgunasakaran1 2012-01-31 18:42
Ing. Helmut Schütz