Steady state [PK / PD]

posted by Imran  – Mumbai, 2007-01-10 10:52 (7090 d 20:56 ago) – Posting: # 449
Views: 8,710

Dear MGR

For SS study u need to estimate Cmin, Cmax, AUC0-tau, PTF.

These parameters can be calulated by any PK software such as WinNonlin or SAS. SS achived can be proved statistically by regression analysis. For more information u can refer USFDA guidance or CPMP guidlines for Extended release product.

I hope ur querry is answere to some extent

regards

Dr.Imran Khan
—
Dr.Imran Khan

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