BN Business News
Add your company to Business Communicator →

Zdrowie i gospodarka · 10/06/2015

Identification of Alternative In Vitro Bioequivalence Pathways Which Can Reliably Ensure In Vivo Bioequivalence of Product Performance and Quality of Non-Systemically Absorbed Drug Products for Animals; Reopening of the Comment Period

The Food and Drug Administration (FDA) is reopening the comment period related to the use of in vitro methods as a mechanism for assessing the in vivo product bioequivalence (BE) of nonsystemically absorbed drug products intended for use in veterinary species, published in the Federal Register of March 18, 2015 (80 FR 14146). FDA is reopening the comment period to update comments and to receive any new information.

Source: Federal Register — Food and Drug AdministrationOpen original release →