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 ...
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 ...
Comparisons of AUCinf and Cmax between Phase 3 and phase 2b formulations, and planned commercial and Phase 2b formulations: 90% CI = 90% Confidence Interval; Ratio (Test/Reference); BE LL 90% CI = ...
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 ...
PRINCETON, N.J., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Certara (Nasdaq: CERT), a global leader in biosimulation, today announced the Company has been awarded a grant from the U.S. Food and Drug ...
In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) ...
A leading journal in its field for more than three quarters of a century, the Bulletin spans the social, cultural, and scientific aspects of the history of medicine worldwide. Every issue includes ...
Ibuprofen is absorbed from the gastro-intestinal tract and peak plasma concentrations are reached within about 1 to 2 hours after ingestion. Bioavailability is ≥ 80%. 99% of ibuprofen is bound to ...
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