Bioequivalence and Bioavailability Forum 03:43 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

BRB
Junior

Canada,
2018-01-03 21:42

Posting: # 18137
Views: 820
 

 FDA Draft guidance on Good ANDA Submission Practices [Regulatives / Guidelines]

Hi all,

The FDA just posted a draft guidance on Good ANDA submission practices:

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM591134.pdf


I found the section on deviations from product-specific guidances to be rather interesting such as:

A detailed justification for and data (such as their inclusion/exclusion criteria or demographic information) to support why their use of a particular study population does not affect their BE determination.

So for imatinib BE studies, which have been done in healthy subjects, but the guidance recommends to use patients, a detailed justification now needs to be provided?

BRB
Activity
 Thread view
Bioequivalence and Bioavailability Forum |  Admin contact
18,914 posts in 4,036 threads, 1,283 registered users;
online 20 (0 registered, 20 guests [including 13 identified bots]).

Statistics is, or should be, about scientific investigation
and how to do it better, but many statisticians believe
it is a branch of mathematics.    George E.P. Box

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed