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| ADDL DATA ITEM |
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MEANING: Additional Dose (ADDL) data item for PREDPP
CONTEXT: $INPUT record and NONMEM data set
USAGE:
$INPUT ... ADDL ...
DISCUSSION:
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 ("initi-
ating") 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.
With NM75 there is a new way of computing SS, the Empirical method, in
which there is no SS data item, and a negative value of ADDL requests
the computation. This is described separately.
(See empirical_SS).
(See Guide Introduction_7 "An Empirical Method of Achieving Steady
State")
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).
REFERENCES: Guide VI Section V.K
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