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RegisterBE Opthalmic Suspension [Regulatives / Guidelines]
Dear All,
Please help me below query
We are looking to conduct Bioequivalence study on an ophthalmic product “Loteprednol Etabonate” Ophthalmic suspension.
In this study the OGD recommended 90% CI and the acceptance range for Bioequivalence based upon 90% confidence interval of (Rt ±1.645 St) lies with in (0.8, 1.25).
Here,
What is St stands for?
What is the significance of value 1.645 whether it is constant or not.
How to develop Bootstrapping technique by manually or software?
Please help me below query
We are looking to conduct Bioequivalence study on an ophthalmic product “Loteprednol Etabonate” Ophthalmic suspension.
In this study the OGD recommended 90% CI and the acceptance range for Bioequivalence based upon 90% confidence interval of (Rt ±1.645 St) lies with in (0.8, 1.25).
Here,
What is St stands for?
What is the significance of value 1.645 whether it is constant or not.
How to develop Bootstrapping technique by manually or software?
Complete thread:
- BE Opthalmic Suspensionbalakotu 2012-02-07 09:03 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE Opthalmic Suspension ElMaestro 2012-02-07 09:55
- BE Opthalmic Suspension balakotu 2012-02-07 11:12
- BE Opthalmic Suspension ElMaestro 2012-02-07 12:11
- BE Opthalmic Suspension pash413 2015-04-10 07:44
- BE Opthalmic Suspension balakotu 2012-02-07 11:12
- BE Opthalmic Suspension ElMaestro 2012-02-07 09:55
Ing. Helmut Schütz