Bioequivalence and Bioavailability Forum

Dear Suchit,

❝ if i want to validate dry ice then what should be the procedure ?

Dry ice is never be validated.

In validation we are performing different stability studies by considering probable scenario in actual conduct of clinical or bioanalytical phase.
For example
1) During clinical & bioanalytical phase there may be chances that plasma samples may be freez and thaw repeatdly that's why we are performing freeze thaw stability.
2) As we are keeping storing plasma samples in deep freezers for long period of time so we have to perform long term stability for particular period at required temperature.

I will suggest you to disscuss these stability approach in validation with one of your bioanalytical personnel. Do your home work. I will confidant that you will completely extract proper meaning of my last post after that.

Regards,
Swapnil D. Kuche

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Edit: Standard quoting character (‘»’) restored – please leave them in place in the future! [Helmut]