Bioequivalence and Bioavailability Forum

Loky do ★ Egypt, 2022-05-11 17:45 (1497 d 22:00 ago) Posting: # 22971 Views: 5,422	PK parameters [PK / PD] Post reply
	Dears if the predefined PK parameters in BE study included AUC(0-t) i.e. truncated and the practical results of t1/2 was lower than planned in protocol and allowed the calculation of AUC0-t and AUC0-inf instead, is it possible to predefine this criteria in protocols (to use AUC-inf instead of AUC 0-t in such cases) or to issue protocol deviation from the stated PK parameters? Thanks in advance

dshah ★★ India, 2022-05-12 13:42 (1497 d 02:04 ago) @ Loky do Posting: # 22972 Views: 4,212	PK parameters Post reply
	Hi Loky do! I believe it is better to issue a protocol deviation form and then use AUC0-t and AUC0-inf. Regards, Divyen

mittyri
★★

Russia,
2022-05-15 00:21
(1494 d 15:25 ago)

@ Loky do
Posting: # 22987
Views: 4,134

predefine in the Protocol whenever possible

Post reply

Dear Loky do,

all predefined decision trees will point out the quality of your Protocols. The expert could clearly see during review that you did not want to cherry pick or use some unexpected posthoc findings.
I am just guessing about AUClast - if the coverage is supposed to be initially not so good (residual area > 20%), are the experts OK with that? Aren't they requesting in your jurisdiction to follow the rule '> 80% of residual areas should be less than 20%'?

—
Kind regards,
Mittyri

PK parameters [PK / PD]

PK parameters

predefine in the Protocol whenever possible