Bioequivalence and Bioavailability Forum

Hi,

The Clinical Trials and BA/BE studies are two different sections in the Pharmaceutical Industry.

I would like to know the necessary and sufficient standard operating procedures i.e. SOPS to be prepared and maintained in the Clinical Trials and BA/BE studies sections before conducting the trial.

Is it mandatory to have different SOPS as per the requirements of the regulatory agencies?

For example:- In USFDA there's no technique provided for detecting the outliers in the pharmacokientic data whereas there are some technique's provided for detecting the outliers in the pharmacokinetic data in ANVISA Brazil, Statistical step.

How to handle such situations if occured?

Venu