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RegisterCorrection Factor for Protein Binding [Bioanalytics]
Hari,
For Bioequivalence study of the formulation, you need to Compare the Test and reference (innovator) product.
You can refer orange book and OGD (office of generic drugs of FDA).
Even if your formulation Bioequivalence/ NCE you need prove Recovery in method validation is satisfactory.
As your Calibration standards, Quality Controls and study sample, reference study samples will be processed under same conditions.
You may consider same values for Statistics.
Not required to calculate free and bound form.
For Bioequivalence study of the formulation, you need to Compare the Test and reference (innovator) product.
You can refer orange book and OGD (office of generic drugs of FDA).
Even if your formulation Bioequivalence/ NCE you need prove Recovery in method validation is satisfactory.
As your Calibration standards, Quality Controls and study sample, reference study samples will be processed under same conditions.
You may consider same values for Statistics.
Not required to calculate free and bound form.
Complete thread:
- Correction Factor for Protein Binding Dr. Harish L. Rao 2008-07-03 07:29
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Correction Factor for Protein Binding martin 2008-07-08 14:51
- Total drug is measured Helmut 2008-07-08 19:21
- Correction Factor for Protein Bindingvamshi 2008-08-14 11:29
- Correction Factor for Protein Binding martin 2008-07-08 14:51
Ing. Helmut Schütz