Scaling of Cmin [Regulatives / Guidelines]

posted by Dr_Dan  – Germany, 2014-12-10 18:21 (3395 d 23:53 ago) – Posting: # 14049
Views: 13,239

Dear kumarnaidu

❝ That means we have to use the 4 way (Fully replicate) method here but with a different sequence RRTT or TTRR


No, you do not need to use a 4 period replicate design: You will have 2 periods and 2 sequences, you just need to dose until you reach steady state, take then the PK profile for the dosing interval and after an afreshed dosing for the consecutive interval.

e.g.:
1st dosing drug1
2nd dosing drug1
3rd dosing drug1
4th dosing drug1
5th dosing drug1 -> PK Profile
6th dosing drug1 -> PK Profile
1st dosing drug2
2nd dosing drug2
3rd dosing drug2
4th dosing drug2
5th dosing drug2 -> PK Profile
6th dosing drug2 -> PK Profile


Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan

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