Bioequivalence and Bioavailability Forum

Hi all,

new regulation from CDSCO: Link here.

This could quickly get complicated to the point where companies are seeking ways to game the system. When is a PI involved in the conduct?

• If (s)he delegates a task to sub-investigators is (s)he then involved (I'll vote yes)?
  
• Does involvement stop at the point the last plasma sample is sent away for analysis (in case no follows-ups are needed)?

If PI involvement correlates with PI responsibility then I guess the PI is involved until the time (s)he has put her/his signature on the final study report.

If an Indian generic company conducts a trial outside India, must the Indian company then ensure that the PI wherever (s)he works is still observing this regulation?