Bioequivalence and Bioavailability Forum

Hi nobody,

❝ Yeah, but the outcome of the study was, sorry to say, negative.

Quotes from:

• Participants
  A written “consent” (specific to the drug to be administered) was obtained from each volunteer; being told that the study compares the effects of tablets/capsules containing placebo to those containing the particular drug on a new serum marker, that it aims to determine how much of the observed changes in the serum marker is not related to the particular drug, and that they will each receive both the drug and placebo in a random sequence. At the completion of the three studies […], the volunteers were contacted for debriefing on the actual study aim and design and for delayed full consenting.
  
• Procedures and intervention
  To enhance the placebo effect, immediately before drug administration, the volunteers were individually briefed and requested to read and sign an additional “consent” document that stated: “As you know, we are doing this study to determine how much of the change in serum marker level that occurs after ingestion of (name and dose of drug) is not related to (name of drug) effect but to placebo effect. This study has two parts. One time you will take (name of drug) and one time you will take a placebo. The placebo is not known to affect the level of the marker. Today you are assigned to take (name of drug or placebo).” Overt drugs were dispensed from the original brand manufacturer bottle, whereas covert drugs were dispensed from a bottle labelled “placebo”.

At the end “BE” was shown for the three drugs. Only C_max of ibuprofen wasn’t cause the study was underpowered even for a T/R-ratio of 1. You are right that the study didn’t address the issue of blinded / open directly. In BE that would require a double-dummy technique, which is not acceptable cause it may delay absorption.

❝ @TheManWithTheFence: My favourite is "The Literature" so you can say you studied thoroughly The Literature.

Äh, wer?

❝ […] I missed the button for "Edit", simply it's normally over/under your post …

As designed and described.

❝ … in any recent forum software.

Last update on Feb 10^th.

If you want to have the edit-link below your post, change your preference to thread view in your profile. I could move it to the top but that’s a lot of coding (up to five links for mods / admins) and nobody [pun] except you complained so far. A f**ing lot of coding to change the link to a button.
I will definitely not move it from the left bar in mix view.