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To bridge the gap between in vitro and pharmacokinetic assessment of bioequivalence, modification of the experimental setup with the use of Peak VesselsTM and the validation of dissolution specifications with virtual bioequivalence trials appear to be promising approaches. However, neither approach is currently foreseen by the harmonized ICH M9 BCS-based biowaiver guidance. The Ser/Thr protein phosphatase Ppz1 from Saccharomyces cerevisiae is the best characterized member of a family of enzymes only found in fungi. Ppz1 is regulated in v