(bioequivalence) requirements - BEBAC â¢ Consultancy Services for ...

More documents

Recommendations

Info

Practically meeting modified release BE (bioequivalence) requirementsNCA (alternative metrics)informalife sciencesComparison of the shape of profilesf 1 ‘Difference factor‘; borrowed from dissolutiontestingf 1proportional to the average difference between thetwo profilesf1= 100 ⋅t=n∑t=1CR, t T , tt=n∑t=1R,tSuggested cut-off: Bioequivalent if f 1≤ 20* JW Moore and HH FlannerMathematical Comparison of curves with an emphasis on in vitro dissolution profilesPharm Tech 20/6, 64–74 (1996)Innovations in Modified Release | Evening Seminar | Berlin, 8 November 2011iC− Cii24
Practically meeting modified release BE (bioequivalence) requirementsNCA (alternative metrics)Comparison of the shape of profilesProblems with f 1Not a statistic!Value dependent on the location and number ofsampling time pointsUses differences (rather than ratios) ofconcentrations (additive instead of multiplicativemodel)Arbitrary cut-off (≤ 20) suitable?informalife sciencesInnovations in Modified Release | Evening Seminar | Berlin, 8 November 201125
Page 3 and 4: Practically meeting modified releas
Page 23: Practically meeting modified releas
Page 71: Practically meeting modified releas

(bioequivalence) requirements - BEBAC â¢ Consultancy Services for ...

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

Delete template?

Save as template?

(bioequivalence) requirements - BEBAC â¢ Consultancy Services for ...