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RegisterPK Parameters for Bioequivalent Criteria [Regulatives / Guidelines]
Dear Om Prakash
To state which primary PK Parameters you need you need to know which territory is planned for submission (US, Europe, …).
However in each case you do not only show bioequivalence for Cmax but at least also for AUC (Cmin, partialAUC, … etc.). In General acceptance criteria 80 – 125% unless intraindividual variability allows to widen the acceptance range.
To state which primary PK Parameters you need you need to know which territory is planned for submission (US, Europe, …).
However in each case you do not only show bioequivalence for Cmax but at least also for AUC (Cmin, partialAUC, … etc.). In General acceptance criteria 80 – 125% unless intraindividual variability allows to widen the acceptance range.
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- PK Parameters for Bioequivalent Criteria omprakash 2017-01-23 12:21
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- PK Parameters for Bioequivalent CriteriaDr_Dan 2017-01-23 13:32
- PK Parameters for Bioequivalent Criteria omprakash 2017-01-28 07:17
- PK Parameters for Bioequivalent Criteria Muthu Raj 2017-02-04 12:58
- Australia’s = EMA’s MR guideline Helmut 2017-02-04 18:25
- Australia’s = EMA’s MR guideline Muthu Raj 2017-02-06 12:01
- Australia’s = EMA’s MR guideline Helmut 2017-02-04 18:25
- PK Parameters for Bioequivalent Criteria Muthu Raj 2017-02-04 12:58
- PK Parameters for Bioequivalent Criteria omprakash 2017-01-28 07:17
- PK Parameters for Bioequivalent CriteriaDr_Dan 2017-01-23 13:32
Ing. Helmut Schütz