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

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Pharmacokinetic Analysis of BE DataTo bear in Remembrance...Whenever a theory appears to youas the only possible one, take this asa sign that you have neither under-stood the theory nor the problemwhich it was intended to solve.Even though it’s applied sciencewe’re dealin’ with, it still is – science!Karl R. PopperLeslie Z. BenetBioequivalence Assessment of Oral Dosage Forms: Basic Concepts and Practical ApplicationsLeuven, 5–6 June, 20132• 68
Pharmacokinetic Analysis of BE DataNCA vs. PK Modeling•Pharmacokinetic models•Useful for understanding the drug/formulation• Study design of BA/BE, e.g.,washout, accumulation / saturation to steady state•Drawbacks• Almost impossible to validate (fine-tuning of sideconditions, weighting schemes, software, …)• Still a mixture of art and science• Impossible to recalculate any given dataset using differentsoftware – sometimes even different versions of the samesoftware!• Not acceptable for evaluation of BE studies!Bioequivalence Assessment of Oral Dosage Forms: Basic Concepts and Practical ApplicationsLeuven, 5–6 June, 20133• 68
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