Bioequivalence and Bioavailability Forum

Dear Santosh and drgopal,

❝ sodium vapour lamp (for dispensing of light sensitive drug)

Have a look at this thread for a previous discussion on the dispensing of light-sensitive drugs.

Remember also that you should have personnel qualified and trained to do the dispensing. Dispensing is a critical step in your trial. According to presentations made at the EGA meetings in 2007 and 2008, European inspectors tend to consider this as packaging and not just dispensing. Which means that they expect it to be done under GMP - and to be documented as such.

Regards
Ohlbe