Pharmacokinetic and Statistical Analysis of BE Data - BEBAC ...

More documents

Recommendations

Info

Pharmacokinetic and Statistical Analysis of BE Data Cross-over over design: Assumptions Multiplicative Model (X-over without carryover) X = µ ⋅π ⋅Φ ⋅s ⋅e ijk k l ik ijk •All ln{s ik } and ln{e ijk } are independently and normally distributed about unity with variances σ² s and σ² e . This assumption may not hold true for all formulations; if the reference formulation shows higher variability than the test formulation, a ‘good’ test will be penalized for the ‘bad’ reference. •All observations made on different subjects are independent. This assumption should not be a problem, unless you plan to include twins or triplets in your study… 1 st MENA Regulatory Conference on Bioequivalence, Biowaivers, Bioanalysis and Dissolution | Amman, 23 – 24 September 2013 22 • 50
Pharmacokinetic and Statistical Analysis of BE Data Cross-over over designs (cont’d) •Standard 2×2×2 design •Advantages • Globally applied standard protocol for bioequivalence, PK interaction, food studies • Straigthforward statistical analysis •Disadvantages • Not suitable for drugs with long half life (→ parallel groups) • Not optimal for studies in patients with instable diseases (→ parallel groups) • Not optimal for HVDs/HVDPs (→ Replicate Designs) 1 st MENA Regulatory Conference on Bioequivalence, Biowaivers, Bioanalysis and Dissolution | Amman, 23 – 24 September 2013 23 • 50
Page 1 and 2: Pharmacokinetic and Statistical Ana
Page 21: Pharmacokinetic and Statistical Ana

Pharmacokinetic and Statistical Analysis of BE Data - BEBAC ...

Create successful ePaper yourself

Delete template?

Save as template?