Bioequivalence and Bioavailability Forum

Hi Dixit,

❝ Suppose a study is done on Lorazepam 2.5 mg, a Benzodiazepine, considering a wash out of 07 days (half life 9-16 hrs) and if the test gives a positive result in Period II, should the volunteer be included in the study or excluded.

This is really a difficult case if you do not have SOPs or a protocol that deal with this situation.
Can you tell why the drug screen is used prior to p2? Is there wording anywhere that describes what a positive result prior to p2 means?

Anyways, if you have reason to believe the subject has taken BZ's in the washout period then I'd discard the subject. Note that although the Helsinki dec protects vulnerable people, the term vulnarable was mainly ment to designate people whose rights are compromised (drug abusers not necessarily in that category), so exclusion on basis of vulnerability is perhaps not a good argument for exclusion in this case.
I would exclude if you have proof that the BZ is not Lorazepam. If you consider it ethically acceptable and technically feasible, then dose the subject and run additional analyses to ID the BZ (-metabolite) and decide later on basis of the ID. but note that depending on how your informed consent was worded and the info given when the subject signed you could be in a situation where such an analysis is not considered appropriate.

In hindsight this might be something to learn from, especially the use and usefulness of a BZ test prior to p2.

Whatever you do, your choice is likely to be disputed by someone
Since the CV for Lora is not frighteningly high I guess you might end up being asked for both analyses, without much danger involved.