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RegisterSABE or Normal BE? [RSABE / ABEL]
Hi,
Where do you get page 3? I only see page 2. Is your link correct or I am still sleeping here in the east coast USA? The document I read is dated "Finalized Sep 2009, Revised Dec 2012"
FDA wants you to compare the intrasubject variation between test and reference which full replicate will give. Reason is that the difference needs to be minimal since the product is a NTI. Differences as a result of inferior pharmaceutical / manufacturing quality may be dangerous when patients switch from brand to generics. Only full replicate study will give you this info. See this slides from a FDA meeting NTI BE Presentation
Back to the page 3 info which I don't see.
If a parameter passes ABE, it should pass SABE correct? Okay it doesn't necessary work the other way around. But in this case, since the intrasubject variability is less than 30% (as per FDA's info on the guidance), a properly powered study with an acceptable test formulation should have no issue passing both correct?
Just my 2 cents...
John
❝ Recently US FDA has published a Draft Guidance on Tacrolimus Capsule bioequivalence where it has suggested following
Where do you get page 3? I only see page 2. Is your link correct or I am still sleeping here in the east coast USA? The document I read is dated "Finalized Sep 2009, Revised Dec 2012"
❝ a) Now in view of these lines, does a full replicate study is really going to help any sponsor in getting widening or still need to follow 80-125?
FDA wants you to compare the intrasubject variation between test and reference which full replicate will give. Reason is that the difference needs to be minimal since the product is a NTI. Differences as a result of inferior pharmaceutical / manufacturing quality may be dangerous when patients switch from brand to generics. Only full replicate study will give you this info. See this slides from a FDA meeting NTI BE Presentation
Back to the page 3 info which I don't see.
❝ Use the unscaled average bioequivalence procedure to determine BE for individual PK parameter(s). Every study should pass the scaled average bioequivalence limits and also regular unscaled bioequivalence limits of 80.00-125.00%
If a parameter passes ABE, it should pass SABE correct? Okay it doesn't necessary work the other way around. But in this case, since the intrasubject variability is less than 30% (as per FDA's info on the guidance), a properly powered study with an acceptable test formulation should have no issue passing both correct?
Just my 2 cents...
John
Complete thread:
- SABE or Normal BE? luvblooms 2013-02-19 05:07 [RSABE / ABEL]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDA: rSABE for NTIDs Helmut 2013-02-19 11:05
- SABE or Normal BE?jag009 2013-02-19 15:23
- Sample size? Helmut 2013-02-19 17:25
- SABE or Normal BE? luvblooms 2013-02-20 05:26
- SABE or Normal BE? jag009 2013-02-20 15:20
- SABE or Normal BE? Helmut 2013-02-20 15:45
- SABE or Normal BE? ElMaestro 2013-02-20 16:08
- SABE or Normal BE? jag009 2013-02-21 17:10
- FDA’s example data sets Helmut 2013-02-21 17:18
- FDA’s example data sets jag009 2013-02-21 20:14
- FDA’s example data sets Helmut 2013-02-21 22:42
- FDA’s example data sets jag009 2013-02-22 15:46
- FDA’s example data sets Helmut 2013-02-22 16:33
- FDA’s example data sets jag009 2013-02-22 15:46
- FDA’s example data sets Helmut 2013-02-21 22:42
- FDA’s example data sets jag009 2013-02-21 20:14
- FDA’s example data sets Helmut 2013-02-21 17:18
- SABE or Normal BE? jag009 2013-02-21 17:10
- SABE or Normal BE? ElMaestro 2013-02-20 16:08
Ing. Helmut Schütz