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Dear PharmPK forum members,
For exposure assessment (toxicokinetics) in subacute toxicity
study, 4 to 8 sampling points are recommended by ICH S3A
guidelines. If there are 3 points around Tmax to pick up peak
concentration (Cmax)and one at 24 hrs, how correct will be AUC
estimation? Is it necessary to increase sampling points? How
important is accumulation index/ratio determination? For what kind
of drugs it is required?
Thanks in advance
V. D. Pawar
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)