Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Individual bioequivalence interim approach urged to allow more data gathering.

This article was originally published in The Tan Sheet

Executive Summary

INDIVIDUAL BIOEQUIVALENCE INTERIM APPROACH PROPOSED to allow an expert panel assembled by FDA to gather more data on the criteria needed to define the term individual bioequivalence, panel member Leslie Benet, PhD, University of California at San Francisco, told an American Association of Pharmaceutical Scientists workshop in Arlington, Va. March 16-18. The expert panel, which met during the AAPS workshop, recommends FDA use an "interim measure" that would allow "intermediate average bioequivalence with mixed scaling, including full replicate design," Benet said.
Advertisement
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS088265

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel