Pharmacokinetic Analysis of BE Data - BEBAC â¢ Consultancy ...

More documents

Recommendations

Info

Pharmacokinetic Analysis of BE DataNCA (Methods)200plasma profile (linear scale)concentration1501005000 24 48 72 96 120 144timeC avslope: +0.0459395% CI: [-0.35266 | +0.44452]steady state demonstratedBioequivalence Assessment of Oral Dosage Forms: Basic Concepts and Practical ApplicationsLeuven, 5–6 June, 201332 • 68
Pharmacokinetic Analysis of BE DataNCA (Problems)•C min•Defined by EMA as the concentration (C trough )at the end of the dosing interval τ•Not implemented in PK software: C min globalminimum concentration. Requires adaption.•More variable than C max (if little accumulation closeto LLOQ)•EMA requires pre-dose sampling at ≤–5 min andsampling at τ ±10 min•Common in o.a.d. MD studies last sampleat 23:55 in period 1 and at 24:00 in period 2…Bioequivalence Assessment of Oral Dosage Forms: Basic Concepts and Practical ApplicationsLeuven, 5–6 June, 201333 • 68
Page 1 and 2: Wikimedia Commons • 2005 Snowdog
Page 3 and 4: Pharmacokinetic Analysis of BE Data
Page 31: Pharmacokinetic Analysis of BE Data

Pharmacokinetic Analysis of BE Data - BEBAC â¢ Consultancy ...

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?

Pharmacokinetic Analysis of BE Data - BEBAC â¢ Consultancy ...