Bioequivalence and Bioavailability Forum

Hello drvahe,

❝ Could you please give me advise about orodispersable tablets (ODS)? May an in vivo bioequivalence study demonstrate the bioequivalence of ODT to a film-coated tablet? Could you indicate me a guideline regulating this aspect?

EMA's BE guideline from 2010, section 1.2:
"(...) the various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form."

Have a good weekend.

Dear Drvahe, dear all,

❝ Could you please give me advise about orodispersable tablets (ODS)? May an in vivo bioequivalence study demonstrate the bioequivalence of ODT to a film-coated tablet? Could you indicate me a guideline regulating this aspect?

As you probably know, Armenia is on the joining way into the Eurasian Economic Union (Armenia+Belarus+Kazakhstan+Russia+Kyrgyzstan).
The rules of medicines circulation will come into the force very soon.
So the BEQ guideline is published (I found only russian version, if somebody can share the english version, it would be great!)
The answer to your question you can find on the pdf pages 62-64.

I google-translated it for English-speakers (sentences are merged with a special program), but cannot upload this format (pdf) here. Maybe mighty Administrator can help me.

Some notes:
This guideline is another translation of EMA BEQ guideline ("to improve Russian redbook?? Oh no, we can translate it once again with new tricks and traps!")
By the way some parts are captured from WHO BEQ guideline.
Yes, now we can use waiver for some BCS classes as in EU!
No, we don't know how to deal with modified release drugs... Just do some study and submit it. Maybe it's enough, but we cannot say for sure.
Yes, Tmax is very important PK parameter. If you are'nt sure about clinical significance, please do some unparametric comparison, please.
Two groups? 2 sites??? We cannot be sure about your nitpicked results! Please add the group factor and discuss it with us, we should think about this issue later.
As you see we love innovations: "As fluid intake may influence gastric passage for oral administration forms, the test and reference products should be administered with a standardised volume of fluid (150-250 ml). It is recommended that water is allowed as desired except for one hour before and two hours after drug administration..."