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DISCUSSION This study examined the pharmacokinetic properties and bioequivalence of 2 formulations of sodium valproate 200 mg tablet in healthy Indian adult male subjects. 10 12-13 Our study data show that both sodium valproate formulations the predefined bioequivalence criteria of 80 to 125 for the primary end point of Cmax and AUC. The study results revealed that the 2 formulations of sodium valproate were similar in PK characteristics among th...

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What is bioequivalence study of sodium?

A bioequivalence study of sodium is a scientific study conducted to demonstrate that a generic drug containing sodium as an active ingredient is pharmacologically equivalent to a reference drug that also contains sodium.

Who is required to file bioequivalence study of sodium?

Manufacturers or sponsors of generic drugs that contain sodium as an active ingredient are typically required to file a bioequivalence study of sodium.

How to fill out bioequivalence study of sodium?

To fill out a bioequivalence study of sodium, manufacturers or sponsors need to provide detailed information about the generic drug formulation, the reference drug, the study design, data analysis methods, and results of the study.

What is the purpose of bioequivalence study of sodium?

The purpose of a bioequivalence study of sodium is to demonstrate that a generic drug containing sodium as an active ingredient performs in the same manner as the reference drug, with similar bioavailability and therapeutic effects.

What information must be reported on bioequivalence study of sodium?

A bioequivalence study of sodium typically requires reporting of detailed information on the generic drug formulation, the reference drug, study design, analytical methods, pharmacokinetic data, statistical analysis, and conclusions.

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