Bioequivalence and Bioavailability Forum • withdrawal of subjects

avinash
★

India,
2014-09-17 09:57
(4303 d 07:47 ago)

Posting: # 13526
Views: 3,079

withdrawal of subjects [Regulatives / Guidelines]

Dear Members,

With regard to samples from subjects who have been withdrawn from the study due to adverse events.

Is it required to analyze the data?

Please clarify what exactly is to be done with this data, we are providing this data in separate table (excluding from PK & Stats).

As per Canadian guideline, “Reasons for withdrawal of subjects administered at least one dose of drug (e.g., adverse drug reaction) should be reported, and the subject's plasma (or blood or serum) concentration data should be provided. The results of the bioanalysis of all samples from subjects who were withdrawn from the study should be reported.

Is it required to analyze sample from withdrawn subject for other submission studies?

Please opine.

Thanks & regards,
Avinash Jain

jag009 ★★★ NJ, 2014-09-17 18:52 (4302 d 22:52 ago) @ avinash Posting: # 13528 Views: 2,538	withdrawal of subjects Post reply
	Hi, For generics: We don't do it for USA, but yes for Canada, Europe I don't know. When I did my Canadian studies, we just presented the plasma concentration data of the dropouts due to AEs in a separate table. No PK analysis. John

avinash ★ India, 2014-09-18 07:15 (4302 d 10:29 ago) @ jag009 Posting: # 13533 Views: 2,489	withdrawal of subjects Post reply
	Dear John, Thanks. regards, Avinash