Bioequivalence and Bioavailability Forum

Actual vs. scheduled time [Study Performance]

posted by Helmut – Vienna, Austria, 2009-12-11 15:03 (5666 d 23:24 ago) – Posting: # 4472
Views: 23,245

Dear Pankaj!

❝ … it will always be the actual time points for PK calculation whenever the deviation is more than the acceptable limits as defined in SOP or protocol.

❝ […] we will be taking actual sampling time points only for those cases where it will be a protocol deviation.

Simple-minded question: What is your rationale of using

actual if |deviation| > limits, and
scheduled if otherwise?

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

blood sampling drdds 2007-11-03 11:42 [Study Performance]
- blood sampling Ohlbe 2007-11-04 00:29
- blood sampling Helmut 2007-11-04 01:13
  - blood sampling Ohlbe 2007-11-04 13:25
    - blood sampling Helmut 2007-11-04 13:45
      - blood sampling Dr.Tarak Parikh 2007-11-06 09:59
        
        First Time Cmax Helmut 2007-11-09 17:27
      - blood sampling ratnakar1811 2009-12-10 07:05
        
        blood sampling Pankaj Mishra 2009-12-10 10:05
        
        blood sampling ratnakar1811 2009-12-10 12:46
        
        blood sampling Pankaj Mishra 2009-12-11 10:49
        
        Actual vs. scheduled timeHelmut 2009-12-11 14:03
        
        blood sampling Helmut 2009-12-10 13:13
        
        blood sampling ratnakar1811 2009-12-11 10:16

Actual vs. scheduled time [Study Per­for­mance]

Complete thread:

Actual vs. scheduled time [Study Performance]