Bioequivalence and Bioavailability Forum

Dear MGR,

Thanks for your reply. It is true that the data analysis activity in BA/BE is constrained. Acutally I forget to mention about the requirement of statistical SOPs for BA/BE in the last post. To my knowledge, have planned to implement the following SOPs in place as given below and please let me know other Statistical SOPs need to be incorporated for efficient statistical practice.

1. Randomization Schedule
   
2. Sample size, power calculation including kinetic sampling points
   
3. Handling of analytical data and verification
   
4. Outlier detection and handling
   
5. Crossover & Parallel Design statistical analysis

Many thanks.

Best Regards,
RAJ

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Edit: Full quote removed. Please see this post! [Jaime]