Bioequivalence and Bioavailability Forum

Calculation of ISR deviation [Bioanalytics]

posted by Ohlbe – France, 2013-04-25 00:37 (4417 d 07:34 ago) – Posting: # 10492
Views: 7,729

Dear Helmut,

❝ Which CCIII WP are you referring to?

Sorry I was a bit short in time this morning and I didn't link the paper. I was actually thinking of the white paper of the "Crystal City 3.5" meeting of 2008, by Douglas Fast et al.. The paper by Rocci et al. was published before that meeting and did not involve the FDA.

Regarding the number of samples, do you know this paper by Hoffman ? Too much stats in it for my brain, but you should be able to understand it better

Complete thread:

• Calculation of ISR deviation Helmut 2013-04-23 19:30 
  • Calculation of ISR deviation ElMaestro 2013-04-23 20:30
    • I see… Helmut 2013-04-23 22:08
    • Calculation of ISR deviation Roberto 2013-12-09 12:52
  • Calculation of ISR deviation Ohlbe 2013-04-24 09:40
    • Calculation of ISR deviation Helmut 2013-04-24 14:07
      • Calculation of ISR deviationOhlbe 2013-04-24 22:37
        • Calculation of ISR deviation Helmut 2013-04-25 02:00