Bio-Equivalence Free e-course : Launch

Thanks for subscribing to a short course on Bioequivalence (BE) Studies which has been developed with the aim of providing a basic understanding of BE studies, to help identifying the right partner for outsourcing. Sponsor can select a CRO by looking into their experience, study personnel, volunteer database, certification, meeting timelines and obviously cost. In next 10 chapters this course will cover about study design, regulatory & ethical requirement, pharmacokinetic & statistical aspects of BE studies to help you safe guard your interest by ensuring you are getting what you need from your partner.

The Course contains 10 modules with an introductory part which are listed below :

  1. Introduction
  2. Overview and Flow chart of activities : Module 1
  3. Dissolution and Bioequivalence Studies : Module 2
  4. Study Protocol and Design : Module 3
  5. Standard Operating Procedures in BA/BE Studies : Module 4
  6. Ethical Requirements : Module 5
  7. Regulatory Requirements : Module 6
  8. Pharmacokinetic Aspects : Module 7
  9. Bioanalytical Method : Module 8
  10. Statistical Aspects : Module 9
  11. Study Report Preparation : Module 10

Dr. Manoj Karwa


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