We have launched a short course on BE studies that has been developed with the aim of providing a basic understanding of BE studies. This course will 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 provide a basic understanding of study design, regulatory & ethical requirement, pharmacokinetic & statistical aspects of BE studies.
The prime objective of the course is to help you safeguard your interest by ensuring you are getting what you need from your partner.
The Course conatins 10 modules with an introductory part which are listed below :
- Overview and Flow chart of activities : Module 1
- Dissolution and Bioequivalence Studies : Module 2
- Study Protocol and Design : Module 3
- Standard Operating Procedures in BA/BE Studies : Module 4
- Ethical Requirements : Module 5
- Regulatory Requirements : Module 6
- Pharmacokinetic Aspects : Module 7
- Bioanalytical Method : Module 8
- Statistical Aspects : Module 9
- Study Report Preparation : Module 10