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Summary of the PhRMA Survey of TDI Practices• Survey of 87 questions• Covered strategic and technical aspects, as well ashow TDI data are used for prediction of DDI• Solicited feedback from 32 PhRMA companies;received 17 anonymized responses• Overall conclusion: Far more agreement thandisagreement30
Summary of the PhRMA Survey of TDI Practices• On strategic aspects of TDI:Common PracticesAll assess TDI during drugdiscovery/development continuumTDI data are used for predicting DDIDivergent PracticesTiming of definitive assays forclinical DDI predictions ranges fromlead optimization through phase 1No common cut-off values for TDIdata for further progression of NMEsUse of various study designs for TDIassessment in drug discovery (e.g.,IC 50shift vs % activity loss at singleNME concentration, etc.)No common consideration ofstructural alerts31
Page 3 and 4: IntroductionFrom Appendix C-2 of th
Page 5 and 6: Time-Dependent Inhibition of P450En
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Page 39 and 40: TDI and DDI Decision TreeNME is tes
Page 41: White Paper CoauthorsHeidi Einolf,

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