The US Food and Drug Administration (FDA) has published a new draft guidance on the studies needed to support an abbreviated new drug application (ANDA), more commonly known as generic drug ...
The International Council for Harmonisation (ICH) recently adopted its M13A guideline, which aims to harmonize the framework for assessing the bioequivalence (BE) of immediate-release (IR) solid oral ...
Over 80% of U.S. drug prescriptions are for generic medicines. 1 Such medicines are an important part of the medical system, helping to alleviate drug shortages and improve access to affordable ...
On Friday, the Food and Drug Administration announced a new pilot prioritization program for the review of abbreviated new drug applications that aims to spur and reward investment in U.S. drug ...
Multiple-Dose Studies Can Be a More Sensitive Assessment for Bioequivalence Than Single-Dose Studies
Objective: To evaluate the bioequivalence of two enteric-coated formulations of omeprazole, Losec ® (reference) and Omepradex ® (test). It is hypothesised that formulation differences may be ...
The Supreme Court has been asked to review whether the safe harbor established by 35 U.S.C. § 271(e)(1) encompasses a generic drug manufacturer’s bioequivalence testing performed only as a condition ...
Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed ...
There are over 250 functional drugs manufacturing companies that need to sell the products they are making. Now, how are they selling these drugs? Medical representatives or promotional officers of ...
CHICAGO, July 18, 2017 /PRNewswire/ -- In a significant move, the US Food and Drug Administration (FDA) is asking for public comments on bioequivalence testing of generic drugs, specifically novel ...
It ordered Teva to conduct a bioequivalence test in patients who'd reported problems with the copycat form. Late last year, Teva stopped that study, saying it couldn't find enough patients. Meanwhile, ...
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