Bioequivalence and Bioavailability Forum

CDSCO, India: PI can do 3 trials at a time [Regulatives / Guidelines]

posted by Ohlbe – France, 2014-07-15 19:52 (4363 d 04:03 ago) – Posting: # 13269
Views: 2,132

Dear ElMaestro,

It is indeed very unclear to me and raises tons of questions:

• what is the legal value of this "order" ?
  
• does it apply to BE trials (which I understand are excluded in their vast majority from the scope of Schedule Y as they are not "new drugs") ?
  
• if it applies to BE trials: are 3 trials considered to be run at the same time only if subjects from the 3 trials are in-house at the same time ? Could the PI have the period 1 of 2 trials running during the wash-out period of 2 other trials ?

Complete thread:

• CDSCO, India: PI can do 3 trials at a time ElMaestro 2014-07-15 17:17 
  • CDSCO, India: PI can do 3 trials at a timeOhlbe 2014-07-15 17:52