Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The Learning Portal will be under maintenance Monday, 6 December between 6 AM and 5 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.
Posted 10 October 2014 | By Louise Zornoza,
This content is provided by RegLink News, publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members.
Brazilian regulator Anvisa has released an updated Certification of Good Practice for the conduct of bioavailability/bioequivalence (BA/BE) studies.
The practices are those that must be adopted by research centers in order to ensure their BA/BE studies—comparing pharmacokinetic and pharmacodynamics parameters between a test product and its reference drug or comparator—are conducted correctly and to Brazilian regulatory standards.
One of the changes on the new certification is the validity period, which was changed to two years from the expiration of the previous certificate. BA/BE for registration and post-registration of medicines are also required to be performed in certified test centers.
Tags: BA, BE, Bioavailability, Bioequivalence, Certification of Good Practice
Regulatory Focus newsletters
All the biggest regulatory news and happenings.