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RegisterImputation and BE/TE [RSABE / ABEL]
Hi Pash,
As I see it, imputation has never really been widely used when it comes to proofs of bioequivalence (or ther. eq. / EMA). The only exception I can think of from the top of my head is the quite naïve LLOQ/2 for BLQ PK data (and I am not a fan, by the way).
Imputation is sometimes used by originator firms when they do their proofs of efficacy or safety. EMA was toying with guidance in the area some years ago. Quite controversial, really, and my impression was that it was mainly intended for longitudinal data.
I could be completely wrong but the idea of imputation as a way to save your BE study does not strike me as particularly useful; if you treat all your 'cases' in a similar fashion then you might simply be biasing the dataset towards bioequivalence.
❝ (...) the firm has used the method of Imputation for same molecule (MESALAMINE) which was well accepted by FDA.
❝
❝ We would like to understand the applicability and scope of such statistical methodology.
As I see it, imputation has never really been widely used when it comes to proofs of bioequivalence (or ther. eq. / EMA). The only exception I can think of from the top of my head is the quite naïve LLOQ/2 for BLQ PK data (and I am not a fan, by the way).
Imputation is sometimes used by originator firms when they do their proofs of efficacy or safety. EMA was toying with guidance in the area some years ago. Quite controversial, really, and my impression was that it was mainly intended for longitudinal data.
I could be completely wrong but the idea of imputation as a way to save your BE study does not strike me as particularly useful; if you treat all your 'cases' in a similar fashion then you might simply be biasing the dataset towards bioequivalence.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Zero concentrations – all samples – full replicate pash413 2014-04-05 14:56 [RSABE / ABEL]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Zero concentrations – all samples – full replicate ElMaestro 2014-04-05 20:17
- Zero concentrations – all samples – full replicate luvblooms 2014-04-07 07:47
- serious risk to public health Dr_Dan 2014-04-07 08:35
- Zero concentrations – all samples – full replicate pash413 2014-04-07 08:37
- Zero concentrations – all samples – full replicate Helmut 2014-04-07 09:01
- Zero concentrations – all samples – full replicate pash413 2014-04-07 09:30
- Imputation and BE/TEElMaestro 2014-04-07 12:14
- Zero concentrations – all samples – full replicate nobody 2014-04-07 09:31
- Zero concentrations – all samples – full replicate pash413 2014-04-07 09:30
- Zero concentrations – all samples – full replicate luvblooms 2014-04-07 11:50
- Zero concentrations – all samples – full replicate Mahesh M 2014-04-07 12:23
- Zero concentrations – all samples – full replicate jag009 2014-04-07 16:18
- Zero concentrations – all samples – full replicate jag009 2014-04-07 15:29
- Zero concentrations – all samples – full replicate Helmut 2014-04-07 09:01
- Stability ? Ohlbe 2014-04-07 18:23
- Stability ? Helmut 2014-04-07 19:39
- Stability ? pash413 2014-04-09 13:00
- Stability ? Mahesh M 2014-04-09 14:51
- Stability ? Ohlbe 2014-04-09 16:31
- Stability ? pash413 2014-04-09 13:00
- Stability ? Helmut 2014-04-07 19:39
Ing. Helmut Schütz