About our list of Services

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We ecourage you to contact Ocean Blue Medical Research Center for more questions and/or information about our services.

Bioequivalence

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."

Ocean Blue Medical Research Center' 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.

Bioequivalence Services

  • Protocol writing
  • Phase I trials
  • Bioanalysis
  • Statistics/pharmacokinetics
  • Draft and final reports
Last update: 07/7/2015 11:24
Content updated on Monday, 10-2-2017 04:35:40 am