Bioequivalence and Bioavailability Forum

Hello balakotu,

❝ We are looking to conduct Bioequivalence study on an ophthalmic product “Loteprednol Etabonate” Ophthalmic suspension.

Great. There's trouble ahead.

❝ 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).

❝ What is St stands for?

Standard deviation.

❝ What is the significance of value 1.645 whether it is constant or not.

Try and google "1.645" and you will quickly get the explanation. Mean plusminus 1.645 st.dev. contains the confidence range from the (any) normal distribution. Consider it a constant as long as you work with something Gaussian.

❝ How to develop Bootstrapping technique by manually or software?

By software. You need to sample with replacement "a lot of times", like 500, 5000 or 5 trillion gaziliion times. For that purpose you definitely need proper software with a NLYW.