Open main menu
Home
Random
Recent changes
Special pages
Community portal
Preferences
About Wikipedia
Disclaimers
Incubator escapee wiki
Search
User menu
Talk
Dark mode
Contributions
Create account
Log in
Editing
Bioequivalence
(section)
Warning:
You are not logged in. Your IP address will be publicly visible if you make any edits. If you
log in
or
create an account
, your edits will be attributed to your username, along with other benefits.
Anti-spam check. Do
not
fill this in!
=== The World Health Organization === The World Health Organization considers two formulation bioequivalent if the 90% confidence interval for the ratio multisource (generic) product/comparator lie within 80.00β125.00% acceptance range for AUC<sub>0βt</sub> and C<sub>max</sub>. For high variable finished pharmaceutical products, the applicable acceptance range for C<sub>max</sub> can be expanded (up to 69.84β143.19%).<ref>[https://www.who.int/medicines/areas/quality_safety/quality_assurance/trs1003_annex6.pdf?ua=1 WHO guidelines on Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability WHO Technical Report Series, No. 1003, 2017, Annex 6]</ref>
Edit summary
(Briefly describe your changes)
By publishing changes, you agree to the
Terms of Use
, and you irrevocably agree to release your contribution under the
CC BY-SA 4.0 License
and the
GFDL
. You agree that a hyperlink or URL is sufficient attribution under the Creative Commons license.
Cancel
Editing help
(opens in new window)