Bioequivalence and Bioavailability Forum

About "PK repeats" [Software]

posted by Helmut  – Vienna, Austria, 2010-10-21 19:01 (5314 d 08:13 ago) – Posting: # 6072
Views: 15,941

Dear Ohlbe!

❝ ❝ Following the presentation, a comment was brought forth stating that regulatory agencies recommend against performing PK repeats

❝

❝ Unfortunately. But remember the discussions at the EBF/EUFEPS meeting in Brussels in April: on the European side there is still some hope that the ban will be restricted to BE trials only, not to other PK trials. And there is still a possibility in the draft for repeats for lab investigations. So we are not completely loosing our time.

Yes, I remember.
But I must confess that I don't see the rationale behind 'a ban on BE studies'. Much more is know about the PK of the drug at that stage as compared to FIM or PK-studies of the innovator...

—
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