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Registerendogenous compounds [Bioanalytics]
Dear Subramanian,
Assuming that you are asking for human insulin, the type of study required is not regular BE study, instead conducting glucose clamp studies are more appropriate. Clamp studies are well accepted and standardized for comparing insulin like products.
For your second question on endogenous hormones, base line correction method is good. Take approximately three pre-dose smaples and take average and subtract beofre PK analysis.
Regards,
Dr. Shiv
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Edit: Full quote removed. [HS]
Assuming that you are asking for human insulin, the type of study required is not regular BE study, instead conducting glucose clamp studies are more appropriate. Clamp studies are well accepted and standardized for comparing insulin like products.
For your second question on endogenous hormones, base line correction method is good. Take approximately three pre-dose smaples and take average and subtract beofre PK analysis.
Regards,
Dr. Shiv
--
Edit: Full quote removed. [HS]
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Ing. Helmut Schütz