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Bio Equivalence Studies

Bioequivalence studies are designed to examine whether the systemic bioavailability of a test product and those of the reference product differ significantly. Bioavailability captures how fast the drug enters the systemic circulation (rate of absorption) and how much of the nominal strength enters the body (extent of absorption). Two pharmaceutical products are considered to be bioequivalent if their bioavailabilities, from the same molar dose, are so similar that they are unlikely to produce clinically relevant differences in therapeutic and/or adverse events.
Kreara has extensive experience in performing statistical analysis for Bioequivalence studies. The proficiency of SAS programmers further enhances the computation and presentation of results in an appropriate manner.

The services provided by Kreara in this area are

  • Preparing Statistical Analysis Plan
  • Computation of the Pharmacokinetic parameters using SAS
  • Statistical analysis
  • Statistical reporting of descriptive and Graphical summaries
  • Integrated Final Report


  • "Kreara's agile programming methodology was a welcome change from the previous outsourcing experience that we have had. With a team of 10 people which comprised of a business analyst, a scrum master and 6 programmers and 2 QA engineers, we were able to quickly ramp..." a US based Fortune 500 company

  • "SAS Programmers from Kreara has an exceptional experience across various therapeutic areas. They were also able to do a quick turnaround in the Phase IIB trial by providing the necessary TFLs within one week of database lock" Director Biostatistics of a European CRO

  • "It usually takes about three months to convert a legacy database into the CDISC format. Kreara programmers were able to do it in less than a month with the sound domain knowledge that they had in oncology and CDISC specifications" Director Data Management from a European Pharmaceutical Major

  • "While medical coding remains one of the most costly affairs in Europe, Kreara was able to successfully use the medDRA and WHODD to perform the medication coding at costs that were extremely competitive" Director Data Management of an East European CRO

quick contact

Quick contact info

  • Kreara Solutions Private Ltd.
  • T-4, 7th Floor, Thejaswini Building,
  • Technopark Campus,
  • Thiruvananthapuram (Dist),
  • Kerala State, India.
  • Pin: 695 581
  • Phone: (00)91 - 471 - 2527640
  • Phone: (00)91 - 471 - 3043049