RE: 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).