Wetware required [NCA / SHAM]

posted by Samir Malhotra – India, 2012-06-13 11:39 (4708 d 05:30 ago) – Posting: # 8725
Views: 11,846

A few clarifications: this is data from healthy volunteers aged 18-45y who received a single oral dose. The values are arithmetic mean. We wish to estimate PK parameters. The LLOQ is 1.96
Queries:
1. It was recommended in the Forum to use the last 4 time points for kel. Do we take the last four time points for each or look at the graph of each volunteer and decide (4 points for some and 3 or 5 for others)?
2. The last time point is 72 hours and there are several volunteers in whom no drug was detected. Do we write zero and include that into calculations or we do not take that time point at all for that particular volunteer ?
thanks

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,666 registered users;
79 visitors (0 registered, 79 guests [including 9 identified bots]).
Forum time: 17:10 CEST (Europe/Vienna)

Patients may recover in spite of drugs or because of them.    John Gaddum

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5