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 ...

The FDA has updated its draft guidance on bioequivalence studies with fresh advice for developers of drugs in a range of dosage forms. Publication of the updated draft comes almost eight years after ...

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 ...

Adam Hayes, Ph.D., CFA, is a financial writer with 15+ years Wall Street experience as a derivatives trader. Besides his extensive derivative trading expertise, Adam is an expert in economics and ...

Reassurance as to the bioequivalence of generic formulations of the antiepileptic drug lamotrigine with the branded product, Lamictal (GlaxoSmithKline), has come from a new study sponsored by the US ...

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 ...

Anemia is a serious medical condition affecting millions of people worldwide, characterized by a lack of healthy red blood cells to carry adequate oxygen to the body's tissues. This condition can lead ...

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