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 raps@raps.org 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.
Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. Grab your copy today!
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 03 April 2014 | By Alexander Gaffney, RAC •
The US Food and Drug Administration (FDA) has released 26 new bioequivalence (BE) standards intended to facilitate the development of abbreviated new drug applications (ANDAs) that best meet FDA's expectations for evidence.
Bioequivalence refers to the "absence of a significant difference" between the bioavailability-specifically the extent and rate of absorption-of two (supposed) pharmaceutical drug equivalents over the course of a period of time, at the same dose and under the same conditions. "The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the pioneer drug," FDA explains on its website.
Drugs that are deemed to be bioequivalent are, for regulatory purposes, essentially the same.
But in practical terms, generic drug companies are often most concerned with two things:
In order to facilitate that process, FDA regularly publishes what it calls "bioequivalence recommendations for specific products," which as of April 2014 contains more than 1,150 recommendations.
These recommendations most often contain the recommended number of bioequivalence studies that must be conducted in order to obtain approval, as well as the general designs of the study, acceptable parameters of bioequivalency, and any other considerations sponsors must keep in mind.
On 2 April 2014, FDA released 26 new BE standards, including ones for generic versions of Merck's Lipruzet (atorvastatin, ezetimibe), Pfizer's Inlyta (axitinib), Reckitt Benckiser's Suboxone (buprenorphine HCl; naloxone HCl), Purdue's Butrans (Buprenorphine), Lundbeck's Onfi (Clobazam), transdermal estradiol, and intrauterine levonorgestrel.
Those guidances are still in draft form. FDA also said it had finalized 16 other BE guidances.
073193
74286
Federal Register Notice
Tags: BE Recommendations, Generic Drug, BE, OGD, Latest News, pharmaceutical, bioequivalence, drug