Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2018-01-22 21:22 CET (UTC+1h)
 

FDA Draft guidance on Good ANDA Submission Practices [Regulatives / Guidelines]

posted by BRB - 2018-01-03 21:42  - Posting: # 18137
Views: 296

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The FDA just posted a draft guidance on Good ANDA submission practices: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

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum | Admin contact
17,743 Posts in 3,791 Threads, 1,106 registered users;
32 users online (0 registered, 32 guests).

The analysis of variance is not a mathematical theorem,
but rather a convenient method of arranging the arithmetic.    R.A. Fisher

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