Pink Sheet 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

FDA, Industry Unveil Mechanistic Trial Simulation Models

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA partnered with industry to create four trial simulation models for Parkinson's disease, diabetes, depression and measuring cancer progression, which were unveiled at the Jan. 24-25 Drug Industry Association meeting on "Sharing Knowledge To Improve Clinical Drug Development and Regulatory Decisions.

You may also be interested in...



Otitis Media Studies Can Use Four Trial Designs Under FDA Draft Guidance

FDA's draft guidance for developing drugs to treat acute bacterial otitis media offers sponsors four possible superiority study designs

Analysis Of Recent Drug Reviews Illuminates Path For Future NDAs

Every month, Pharmaceutical Approvals Monthly dissects a new drug review by FDA. Using FDA’s own review documents, including the discipline reviews, decision memos, meeting minutes, emails, and other documents, we strive to illuminate the agency decision-making process.

Otitis Media Studies Can Use Four Trial Designs Under FDA Draft Guidance

FDA's draft guidance for developing drugs to treat acute bacterial otitis media offers sponsors four possible superiority study designs

Latest Headlines
See All
UsernamePublicRestriction

Register

PS003505

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