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) ...

These factors could provide a scientific basis for consistency evaluations of the quality and efficacy of insulin biosimilars, study authors wrote. Factors that may affect the bioequivalence of test ...

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 ...

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The determination of topical bioequivalence requires a multi-faceted approach, tailored specifically to the generic-drug formulation. For a new generic-drug product to be approved by a regulatory ...

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 ...

PRINCETON, N.J.--(BUSINESS WIRE)--Certara ® the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced that its Simcyp ® ...

See related research article by Tsadok and colleagues at www.cmaj.ca/lookup/doi/10.1503/cmaj.101800 and synopsis on page 1371; see also practice article by Mackenzie ...

Daewoong Pharmaceutical and Dongkook Pharmaceutical, which have led the domestic market for precocious puberty treatments containing leuprorelin, are now subject to a re-evaluation of their generics.

A new guideline for conducting bioequivalence studies was adopted by the CPMP in January and it becomes fully effective as of August 2010. A new guideline 1 for conducting bioequivalence studies was ...