Dear all,
I have a question I hope you can help me with. What will the values for ADDL
and II be if I have a subject who has received a total of 19 dose, including
the first dose, every 12 hours? Will it be 18 and 12 or 19 and 12?
Thank you,
BP
Use of ADDL and II
Batul,
As ADDL is the number of additional doses. The answer is 18 and 12.
f.x.
AMT ADDL II
100 18 12
Would give 19 doses of 100 every 12 hours.
Please see below from the NONMEM help files.
BR
Kim Kristensen
Senior Pharmacokinetisist,
M.Sc.(pharm), PhD
_____________________________________________________________________
AstraZeneca
Clinical Pharmacology & DMPK
AstraZeneca R&D Lund,
SE-221 87, Lund, Sweden,
Tel +46 (0)4633 38663 Fax +46(0)4633 6110
Mobile +46 (0)7053 37718
[email protected] <mailto:[email protected]>
ADDL labels PREDPP's additional dose (ADDL) data item. The additional
dose data item is optional. In a dose or reset-dose event record it
describes how many additional doses, exactly like the present ("ini-
tiating") dose, should be given. The interdose interval (II) data
item gives the time between the additional doses (See ii).
When ADDL is 0, no additional doses are given.
For non-steady-state doses, ADDL should be a positive number if and
only if the II data item is a positive number. II gives the time
between additional doses.
For steady-state infusions, ADDL must be 0.
For other steady-state doses, ADDL is optional. If it is a positive
number, it continues the pattern of implied doses beyond the steady-
state dose. The additional doses of the pattern are non-steady state
doses.
For observation, other-type and reset event records, ADDL should be
zero.
The following two data record fragments specify the same set of doses:
TIME AMT ADDL II DV
10. 15. 0 0 .
15. . . . 25.7
20. 10. 0 0 .
22. 15. 0 0 .
34. 15. 0 0 .
36. . . . 30.2
TIME AMT ADDL II DV
10. 15. 2 12. .
15. . . . 25.7
20. 10. 0 0 .
36. . . . 30.2
The observation at time 15 and the extra dose at time 20 do not affect
the regular dosing regimen (doses at times 10, 22, and 34).
There is a discussion of user (concomitant) data items used to compute
PK parameters that are relevant to ADDL doses; (See $BIND).
Quoted reply history
From: [email protected] [mailto:[email protected]]
On Behalf Of Batul Parta
Sent: 27. juli 2011 16:31
To: nonmem
Subject: [NMusers] Use of ADDL and II
Dear all,
I have a question I hope you can help me with. What will the values for
ADDL and II be if I have a subject who has received a total of 19 dose,
including the first dose, every 12 hours? Will it be 18 and 12 or 19 and
12?
Thank you,
BP
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Hello Batul,
ADDL is for additional dosages, and for this case it is 18 (Total -1; 19-1=18),
and II is 12 (dosing interval),
Thus it will be 18 and 12 for your case.
Hope it will help you,
Thanks and regards
RG
Quoted reply history
From: [email protected] [mailto:[email protected]] On
Behalf Of Batul Parta
Sent: Wednesday, July 27, 2011 10:31 AM
To: nonmem
Subject: [NMusers] Use of ADDL and II
Dear all,
I have a question I hope you can help me with. What will the values for ADDL
and II be if I have a subject who has received a total of 19 dose, including
the first dose, every 12 hours? Will it be 18 and 12 or 19 and 12?
Thank you,
BP
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Dear BP,
If you have 19 total doses, then the sum of times when AMT>0 and ADDL value has
to be =19.
For example, you can write:
ID TIME AMT DV ADDL II
1 0 100 0 0 01 12 0 1 18 12
or you can write:
ID TIME AMT DV ADDL II1 0 100 0 0 01 12 100 0
0 01 24 0 1 17 12
Hope it helps,
Best regards
Mario González
Date: Wed, 27 Jul 2011 07:31:26 -0700
From: [email protected]
Subject: [NMusers] Use of ADDL and II
To: [email protected]
Dear all,
I have a question I hope you can help me with. What will the values for ADDL
and II be if I have a subject who has received a total of 19 dose, including
the first dose, every 12 hours? Will it be 18 and 12 or 19 and 12?
Thank you,
BP