Analysis of Non-Pivotal Bioequivalence Studies Submitted in Abbreviated New Drug Submissions for Delayed-Release Drug Products
The US FDA’s rule on “Requirements for Submission of Bioequivalence Data” requiring submission of all bioequivalence (BE) studies conducted on the same formulation of the drug product submitted for approval was published in Federal Register in January 2009. With the publication of this rule, we eval...
Main Authors: | Paramjeet Kaur, Xiaojian Jiang, Ethan Stier |
---|---|
Format: | Article |
Language: | English |
Published: |
Frontiers Media S.A.
2017-07-01
|
Series: | Journal of Pharmacy & Pharmaceutical Sciences |
Online Access: | https://journals.library.ualberta.ca/jpps/index.php/JPPS/article/view/29404 |
Similar Items
-
Global harmonization of immediate‐release solid oral drug product bioequivalence recommendations and the impact on generic drug development
by: Joseph Kotsybar, et al.
Published: (2023-12-01) -
A Bayesian approach to pilot-pivotal trials for bioequivalence assessment
by: Duo Lv, et al.
Published: (2023-12-01) -
Review of bioequivalence studies of cholecalciferol drugs
by: Alexander L. Khokhlov, et al.
Published: (2020-09-01) -
Prospects of Drug Bioequivalence Studies in Pakistan
by: S Khaqan Hasan
Published: (2012-06-01) -
Prospects of Drug Bioequivalence Studies in Pakistan
by: S Khaqan Hasan
Published: (2012-06-01)