The United States Food and Drug Administration (FDA) defines bioequivalence as, "the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study."

Clinical Research Services’ comprehensive services for bioequivalence studies include protocol design and development, clinical conduct, bioanalysis and statistical analysis. Our final study reports for FDA submission are produced using Liquent InSight Publisher™, which automatically compiles source documents with varying file formats into one seamless publication. This technology also supports reporting from Thermo Electron Watson™ LIMS and other software programs.

Bioequivalence Services

• Protocol writing
• Phase I trials
• Bioanalysis
• Statistics/pharmacokinetics
• Draft and final reports