Bioequivalence and Bioavailability Forum

Dear venu!

❝ The Clinical Trials and BA/BE studies are two different sections in the

❝ Pharmaceutical Industry.

I would rather call BA/BE studies a subset of clinical studies

❝ 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.

Straight answer: yes (according to ICH-GCP, ICH Statistical practices, and many country's specific regulations).

❝ 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.

This a very good question!
Actually there is a hierarchy in organisational paperwork:
Top:    the clinical and/or statistical protocol
Bottom: SOPs

In theory (but not in reality!) it should be possible to write a protocol which is mainly a list of SOPs which will be used in the study - although such an approach will make the life of auditors, inspectors and regulatory assessors miserable
Keeping the hierarchy in mind (procedures stated explicitely in the protocol may overrule any SOP), you should proceed as follows:

• Write an SOP for the true 'Standard Operating Procedure' which will be adapted in the majority of studies (i.e., no outlier testing), and
  
• Give a precise description of the outlier-procedure for a particular study, also making clear that the SOP is overruled by the protocol (which is not strictly neccessary, but may be useful if disputes will arise later).