Bioequivalence and Bioavailability Forum • Too short tau?

Too short tau? [NCA / SHAM]

posted by martin – Austria, 2010-01-13 20:45 (5594 d 19:33 ago) – Posting: # 4605
Views: 16,968

Dear HS!

The question of linear PK (dose-proportionality) is also addressed in these kind of studies using data after first study drug administration (usually several doses are studied).

Thanks, wonderful idea to check AUC_inf from previous single dose PK study with AUC_tau obtained from the repeated dose toxicity study (i.e. AUC following last study drug administration); I totally agree!

AUC_tau=AUC_inf in the case of accumulation.
AUC_tau>AUC_inf indicate nonlinear PK.

Interpretation of study results may get complicated in the case that dose-proportionality holds after first study drug administration but AUC_tau after repeated study drug administration is larger than AUC_inf. Any idea what this result could indicate?

best regards

martin

Complete thread:

extent of accumulation martin 2010-01-13 13:38 [NCA / SHAM]
- extent of accumulation ElMaestro 2010-01-13 16:15
  - extent of accumulation martin 2010-01-13 17:45
    - Too short tau? Helmut 2010-01-13 19:14
      - Too short tau?martin 2010-01-13 19:45
        
        Too short tau? Helmut 2010-01-13 20:02
    - extent of accumulation ElMaestro 2010-01-13 20:47
- extent of accumulation Helmut 2010-01-13 18:16
  - principle of superposition martin 2010-01-13 19:14
    - principle of superposition Helmut 2010-01-13 19:34