Bioequivalence and Bioavailability Forum

About "PK repeats" [Software]

posted by Helmut  – Vienna, Austria, 2010-10-21 17:51 (5297 d 15:12 ago) – Posting: # 6069
Views: 15,996

Dear Ohlbe,

just want to continue an old discussion.

❝ ❝ We still reanalyse not only the 'suspect value', but neighbouring values as well. These values serve as internal validators.

❝

❝ Yes, I still do like this concept.

Found an interesting White Paper* from “The 2nd Calibration and Validation Group Workshop on recent issues in Good Laboratory Practice bioanalysis“ held 17-18 April 2008 in Montreal. See R. Phull on ‘Pharmacokinetic repeats’:

The procedure presented for performing PK repeats involved assaying the anomalous value in duplicate, so that three values are available for the sample. An additional approach presented was to assay one sample on either side of the PK repeat.

(my emphasis)
So I’m not alone – but:

Following the presentation, a comment was brought forth stating that regulatory agencies recommend against performing PK repeats; therefore, it is unwise to invest resources in the process.

In other words, don’t invest your time and money in science, but stay at the lab technician’s level of maintaining HPLC’s piping.

Plumbers of the world, unite!

---

• Savoie N, Booth BP, Bradley T, Garofolo F, Hughes NC, Hussain S, King SP, Lindsay M, Lowes S, Ormsby E, Phull R, Rocci ML, Vallano PT, Viau A, Zhu Z. White Paper: The 2nd Calibration and Validation Group Work­shop on recent issues in Good Labora­tory Prac­tice bio­analysis. Bioanalysis. 2009;1(1):19–30. online

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


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Science Quotes

Complete thread:

• BLQ values in Winnonlin Dr. Harish L. Rao 2009-09-10 07:53 
  • BLQ values in Winnonlin Ohlbe 2009-09-11 00:18
    • BLQ values in Winnonlin > Status codes tool SDavis 2009-09-11 08:13
      • BLQ values in Winnonlin > Status codes tool Ohlbe 2009-09-11 22:19
        • Irregular profiles Helmut 2009-09-14 17:11
          • About "PK repeats" Ohlbe 2009-09-14 22:01
            • About "PK repeats"Helmut 2010-10-21 15:51
              • About "PK repeats" Ohlbe 2010-10-21 16:38
                • About "PK repeats" Helmut 2010-10-21 17:01
                  • About "PK repeats" Ohlbe 2010-10-21 17:32
                    • slowly going off-topic Helmut 2010-10-21 18:47
              • About "PK repeats" ElMaestro 2010-10-21 16:56
                • About "PK repeats" Helmut 2010-10-21 18:02
          • BLQ Values in Winnonlin Dr. Harish L. Rao 2009-09-15 05:45