PharmPK Discussion - BE and PK profile

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On 11 Nov 2003 at 14:14:23, Daniel Rossi de Campos (Daniel.Campos.-a-.anvisa.gov.br) sent the message


The following message was posted to: PharmPK

Dear All,

  I would like to know if there is any article that discuss about a
number of points necessary to a pharmacokinetics profile during a BE
studies.
Is there any guidance that describes how many points around Cmáx or in
elimination phase are required ?

Best regards

Daniel

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On 11 Nov 2003 at 09:27:48, "Vuong Trieu" (vtrieu.-at-.AmericanBioScience.com) sent the message


The following message was posted to: PharmPK

Hi:

There are no specific requirements.  However, you would like to have at
least three points at Cmax (Cmax and both sides) and terminal phase
points must be placed so that the % extrapolated for AUCinf is not
greater than 20%.

Vuong

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On 11 Nov 2003 at 13:00:07, "Tata, Prasad N" (Prasad.Tata.-at-.TycoHealthcare.com) sent the message


The following message was posted to: PharmPK

Daniel:

There is no guidance per se on how many points. Normally you extend the
duration of the blood draws until the last measurable concentration is
5% of
the Cmax, then you space oout the blood draws adeqaute to characterize
the
terminal phase, absorption phase. Number of blood draws in a period are
usually determined by the duration of the wash out period, no of
treatments
in a study and volume of the blood drawn at each time point. Often times
IRBs restrict the total blood volume drawn in a study ( to a maximum of
~
500 mL)

The latest BA/BE guidance suggest that there needs to be at least two
measurable concentration before the Tmax (look under the early exposure
measurement section), Same guidance suggest first highest concentration
as
Cmax, to avoid any subjectivity in picking Tmax and Cmax I suggest to
add
2-4 blood draw time points bracketing Tmax.

Hope this helps

Prasad Tata
St. Louis, MO 63134

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On 16 Nov 2003 at 07:40:16, tausif Ahmed (mailtaus.at.yahoo.com) sent the message


Dear Daniel
You should have atleast three ponints in the terminal phase of the drug
and while u are selecting ur sampling points u must be sure that u
select ur time points in such a way that u don't miss the cmax of ur
srug
 
Regards

Tausif Ahmed
Ph.D. Scholar,
Dept. of Pharmaceutical Medicine
Majeedia Hospital, Hamdard University
New Delhi,
India

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