Bioequivalence and Bioavailability Forum

Dear kasi!

❝ ❝ ❝ why we are following water restriction (1 hr pre dose and 1 hr post dose).

❝ ❝

❝ ❝ History?

❝ […] a small request let me know about the history of water restriction, at least brief.

OK, it’s something the FDA likes (which does not conform with many other countries…)
See this post (and followings) for details.

Concerning FDA’s history:

• Nothing was stated in the July 1992 BE Guideline.
  
• The Draft Guideline on Food-Effect Studies (October 1997) stated for the fasted treatments: ‘Following an overnight fast of at least 10 hours, subjects should take the drug product with 180 ml (6 fl oz) of water. […] Water can be allowed ad libitum after 2 hours.’
  
• The 1 h before/after restriction appeared first in the October 2000 BE Guideline and was carried over to the 2003 Revision.

It’s reasonable to restrict fluid intake before administration to some extent, because otherwise subjects will more likely develop difficulties getting FDA’s 240ml down their throats…