Bioequivalence and Bioavailability Forum • Inclusion and Exclusion criteria

Varsha
★

2012-06-15 14:21
(4711 d 12:05 ago)

Posting: # 8742
Views: 4,743

Inclusion and Exclusion criteria [GxP / QC / QA]

Dear All,

In the protocol for an antihypersensitive drug, as an exclusion criteria it was mentioned as diastolic blood pressure less than 80mmHg or more than 90mm Hg.
My question is wheather exclusion criteria shall be maintained only during period 01 Check-in or for all the periods check-in. and also if suppose we have not comply to the exclusion criteris for period 02 what should be our stand.

Regards,
Varsha

kaushik089
★

India,
2012-06-15 15:31
(4711 d 10:55 ago)

@ Varsha
Posting: # 8743
Views: 3,890

Inclusion and Exclusion criteria

Post reply

hello dear varsha

❝ My question is whether exclusion criteria shall be maintained only during period 01 Check-in or for all the periods check-in.

NO, we have to follow for both the periods.

and also if suppose we have not comply to the exclusion criterias for period 02 what should be our stand?

should withdraw the subject immediately followed by raising an adverse event will appropriate.

kaushik panigrahi

Varsha ★ 2012-06-16 10:40 (4710 d 15:47 ago) @ kaushik089 Posting: # 8750 Views: 3,792	Inclusion and Exclusion criteria Post reply
	Thanks Mr. Kaushik. Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]