Bioequivalence and Bioavailability Forum

Spaghetti Viennese [🇷 for BE/BA]

posted by Helmut  – Vienna, Austria, 2019-04-25 16:39 (2055 d 11:51 ago) – Posting: # 20231
Views: 15,195

Dear Ohlbe,

❝ ❝ I’m pissed when I get a report without spaghetti plots.

❝

❝ And you complain that overlaying two plots of means is too crowded

Nope. Overlaying two plots ±SD. I’m fine with one plot of both T and R plus two showing the treatments separately (geom. mean ±SD).

❝ I find spaghetti plots rather difficult to read with more than 30 subjects, or even less depending on what they look like...

You get used to it.
Our brains are great in pattern-recognition. Two examples (amoxicillin 1 g tablets, different tests but same reference in both studies) of Blume/Mutschler*

Study  metric    90% CI 
────────────────────────
  1     AUC    92 – 111%
        Cmax   87 – 109%
  2     AUC    82 –  99%
        Cmax   75 –  99%

Both studies passed (limits for AUC 80–125% and for C_max 70–143%).
@ Mittyri: Good ol’ days! 






I would say:

• Higher concentrations in the second study don’t bother me. Different subjects. The analytical method in the second one was 5times more sensitive and slightly more precise. The former explains why in the first study profiles in some subjects could not be measured up to the last sampling time.
  
• In the second study both treatments were absorbed slightly faster than in the first one.
  
• Now it gets interesting. In the mean curves we see that in the second study the profiles close to C_max are more flat (independent from the formulation). However, individual profiles (yep, the pasta) of the reference in both studies were similar whereas the ones of the tests not. I prefer the second test.

This loose leaf edition (~2,000 pages in 4 volumes, 1989–1996) was prepared for the ABDA („Bundesvereinigung Deutscher Apotherverbände” – Federal Union of German Associations of Pharmacists) to provide pharmacists a means to decide which generic to chose. Already in 1992 ⅓ of all German pharmacists completed a training on BE provided by the ZL (“Zentrallaboratorium Deutscher Apotheker” – Central Laboratory of German Pharmacists). Compare that to the FDA’s Orange Book…

---

• Blume H, Mutschler E, editors. Bioäquivalenz. Qualitätsbewertung wirkstoffgleicher Fertigarzneimittel. Frankurt/Main: Govi-Verlag; 6. Ergänzungslieferung 1996.

—
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:

• Graphing Mean PK profile roman_max 2019-04-23 16:01 [🇷 for BE/BA] 
  • Graphing Mean PK profile Shuanghe 2019-04-23 18:31
    • Graphing Mean PK profile roman_max 2019-04-24 12:29
  • Graphing Mean PK profile Helmut 2019-04-23 22:23
    • Graphing Mean PK profile nobody 2019-04-24 11:23
      • Graphing Mean PK profile Helmut 2019-04-24 11:49
        • Graphing Mean PK profile nobody 2019-04-24 11:53
          • Graphing Mean PK profile Helmut 2019-04-24 12:32
            • Graphing Mean PK profile nobody 2019-04-24 12:49
    • Graphing Mean PK profile roman_max 2019-04-24 12:36
      • Graphing Mean PK profile Helmut 2019-04-24 13:50
        • Graphing Mean PK profile nobody 2019-04-24 14:15
          • Graphing Mean PK profile Helmut 2019-04-24 14:41
            • Pasta Ohlbe 2019-04-25 12:47
              • Pasta nobody 2019-04-25 14:36
              • Spaghetti VienneseHelmut 2019-04-25 14:39
                • Spaghetti Viennese nobody 2019-04-25 15:08
                  • OT: Blume/Mutschler Helmut 2019-04-25 15:32
                    • OT: Blume/Mutschler nobody 2019-04-25 15:43
    • A lie is a lie is a lie ... d_labes 2019-04-25 19:59