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 ...
The US Food and Drug Administration (FDA) has published a new draft guidance on the studies needed to support an abbreviated new drug application (ANDA), more commonly known as generic drug ...
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 ...
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 ...
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 FDA’s finding that the Impax/Teva generic Wellbutrin XL 300 is not the bioequivalent of the GSK product has narrowed the generic antidepressant market to four distributors. The FDA’s findings ...
The bioanalytical testing market offers growth opportunities driven by rising demand for personalized medicine, advancements in analytical technologies, and increased outsourcing to CROs to reduce ...
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Samchundang Pharm surged to the upper price limit early in trading on July 23. This sharp rise is attributed to strong buying interest following the news that the company had successfully completed a ...
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