The U.S. Food and Drug Administration (FDA) issued final guidance on “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms,” which provides advice on conducting bioequivalence (BE) ...
Bioequivalence studies are an essential component in the development and approval of generic pharmaceutical products, ensuring that they perform similarly to their reference counterparts. These ...
The sensitivity and precision of bioequivalence assessments for LT 4 products need to be improved so that the designation of bioequivalence ensures therapeutic equivalence. One solution to this ...
Given data integrity issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on ...
Phase I clinical unit in Secaucus to conduct large scale Phase I and Bioequivalence studies and radiolabeled human AME research.
Raman Spectroscopy and MDRS Enable Determination of the Size and Shape of Specific Components Within a Multicomponent Blend Reviewing the recent approval of an abbreviated new drug application (ANDA) ...
India has made bioequivalence studies mandatory for certain classes of generic drugs before they are launched. The move is to ensure that generic medicines have the same quality and efficacy as their ...
Indian pharmaceutical companies are supporting the recent US FDA guidance on safety reporting requirements for Bioavailability (BA) and Bioequivalence (BE) studies. The new guidelines are seen as a ...
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