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


Clinical Trials Should Include Finding Maintenance Dose, FDA’s Temple Says

Executive Summary

Maintenance doses are not sufficiently studied in clinical trials, FDA Center for Drug Evaluation & Research Medical Policy Director Robert Temple, MD, said

You may also be interested in...

FDA Will Fund Research On “Critical Path” Of Drug Development

FDA's "Critical Path" initiative will redirect the agency's research funding towards identifying and alleviating some major barriers to drug development

FDA Will Begin End-Of-Phase IIa Meetings Prior To January Guidance

FDA will begin a pilot program for end-of-Phase IIa meetings in advance of a draft guidance expected to be issued in early 2004

FDA “Case Studies” On Dosing Problems Include Lotronex, Crestor

FDA believes that use of an exposure-response analysis to establish the optimal dose of GlaxoSmithKline's irritable bowel syndrome agent Lotronex would have prevented its withdrawal

Related Content




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