Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Individual Bioequivalence Interim Approach Proposed To Gather More Data

Executive Summary

An expert panel assembled by FDA is proposing that the agency adopt an interim approach to new bioequivalence methods, panel member Leslie Benet, PhD, University of California(San Francisco, told an American Association of Pharmaceutical Scientists workshop held March 16-18 in Arlington, Va.

You may also be interested in...



Individual BE Replicate Study Design To Be Analyzed Over Two Years By FDA

FDA is planning to conduct a two-year evaluation of its recommended replicate design method to determine whether a transition away from average bioequivalence criterion and towards individual and population BE criteria should occur.

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

Latest Headlines
See All
UsernamePublicRestriction

Register

PS031880

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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