Bioequivalence and Bioavailability Forum

Dear Vijay!

❝ How can you say that the subject is fit to participate in the study without taking x-ray.in our personnel experiance we are not conducting the study without x-ray.can you explain this.

OK, as stated in the original post my point of view comes from my personal (=European) perspective of 500+ BE studies. Additionally, I do not know a single European CRO performing X-rays in screening for BE studies on a routine basis.
Since the tuberculosis incidence rate is that low (<10/100 000) in the EU, no ethics committee would accept X-ray as well (ethical grounds based on risk assessment).

If you are talking from an Indian perspective (where TB is more common), you may opt for the Mantoux-test instead of X-ray testing.

European incidence rates are below 10 in most countries (e.g., 6 in Austria, where I come from), but can be as high as 30 in Lithuania (also an EU-country), or 66 in Romania (new EU member state with January 2007). The rate for India is given with 75 (source). Maybe we should reconsider our procedures at least for some of the new European member states…

For a Canadian perspective see here.

For a discussion have a look at the links already given at David's list.