jag009
★★★

NJ,
2019-08-22 14:53

Posting: # 20506
Views: 780
 

 Intrasubject CV for fed studies [PK / PD]

Hi,
Does anyone know if it is possible to estimate the intrasubject CV of a drug for a fed study if only the food effect data is available (and fasting BE study data)?

Thanks
J
ElMaestro
★★★

Belgium?,
2019-08-22 21:56

@ jag009
Posting: # 20507
Views: 684
 

 Intrasubject CV for fed studies

Hi jag,

» Does anyone know if it is possible to estimate the intrasubject CV of a drug for a fed study if only the food effect data is available (and fasting BE study data)?

It is not readily possible. Both a negative and a positive food effect can be accompanied by a decreased or increased CV. You'll need to work hard for this one :crying:

I could be wrong, but...
Best regards,
ElMaestro
zaibo liu
☆    

China,
2019-08-23 02:54

@ jag009
Posting: # 20508
Views: 677
 

 Intrasubject CV for fed studies

» Does anyone know if it is possible to estimate the intrasubject CV of a drug for a fed study if only the food effect data is available (and fasting BE study data)?

It is not possible, but intrasubject CV is always small than fasting for BCS II or first pass drug.
jag009
★★★

NJ,
2019-09-04 06:32

@ zaibo liu
Posting: # 20538
Views: 518
 

 Intrasubject CV for fed studies

Thanks guys,

» It is not possible, but intrasubject CV is always small than fasting for BCS II or first pass drug.

You mean ISCV is smaller under fed (than fasting) for BCS II? Any example drug?

Thanks
John
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