Visit the Dissolution laboratories at Bayer schering Pharma Ag in ...
Visit the Dissolution laboratories at Bayer schering Pharma Ag in ...
Visit the Dissolution laboratories at Bayer schering Pharma Ag in ...
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Programme(cont'd)OOS Results <strong>in</strong> <strong>Dissolution</strong> Test<strong>in</strong>g• When is a result OOS and when is it not?• Performance verific<strong>at</strong>ion issues• Failure <strong>in</strong>vestig<strong>at</strong>ions <strong>in</strong> dissolution test<strong>in</strong>g• Are st<strong>at</strong>istical outlier tests useful as part of dissolution test failure <strong>in</strong>vestig<strong>at</strong>ions?• Document<strong>in</strong>g <strong>the</strong> outcome of <strong>the</strong> failure <strong>in</strong>vestig<strong>at</strong>ion.Dr Christopher Burgess, Burgess Analytical ConsultancyThe Importance of Biowaiv<strong>in</strong>g <strong>in</strong> Drug Product Development• Overview of regul<strong>at</strong>ions• Differences between US/EU and Japan• The role of biowaivers dur<strong>in</strong>g drug product development• Types of biowaivers e.g. BCS based, proportional similar products• Wh<strong>at</strong> d<strong>at</strong>a are necessary−−how to select b<strong>at</strong>ches−−how many b<strong>at</strong>ches need to be compared−−media selectionCase Studies (Phase III - commercial, additional strength, fixed dose comb<strong>in</strong><strong>at</strong>ion)Dr Thomas Fürst, Boehr<strong>in</strong>ger Ingelheim<strong>Dissolution</strong> Profile Comparison; Approaches and Issues• <strong>Dissolution</strong> processes and d<strong>at</strong>a variability• Wh<strong>at</strong> are we try<strong>in</strong>g to compare?• Wh<strong>at</strong> do <strong>the</strong> agencies specify?• Model <strong>in</strong>dependent approaches• Examples of approachesDr Christopher Burgess, Burgess Analytical ConsultancyApplic<strong>at</strong>ion for a Market<strong>in</strong>g Authoris<strong>at</strong>ion: D<strong>at</strong>a Required for <strong>the</strong> Justific<strong>at</strong>ion and for<strong>the</strong> Submission of <strong>Dissolution</strong> Methods• Required d<strong>at</strong>a and dissolution profiles• Justific<strong>at</strong>ion of discrim<strong>in</strong><strong>at</strong>ory power and robustness of <strong>the</strong> dissolution method• Selection of <strong>the</strong> analytical method• Method transfer on autom<strong>at</strong>ic systemsDr Kerst<strong>in</strong> Pauli, <strong>Bayer</strong> Scher<strong>in</strong>g <strong>Pharma</strong><strong>Visit</strong> of <strong>the</strong> <strong>Dissolution</strong> Labor<strong>at</strong>ories <strong>at</strong> <strong>Bayer</strong> Scher<strong>in</strong>g <strong>Pharma</strong> AG, Berl<strong>in</strong>In <strong>the</strong> afternoon of <strong>the</strong> second course day all participants and speakers are <strong>in</strong>vited to aguided tour to <strong>the</strong> new dissolution labor<strong>at</strong>ory <strong>at</strong> <strong>Bayer</strong> Scher<strong>in</strong>g <strong>Pharma</strong> AG <strong>in</strong> Berl<strong>in</strong>.The dissolution lab is equipped with various autom<strong>at</strong>ed dissolution systems applicable tocover multiple aspects occurr<strong>in</strong>g dur<strong>in</strong>g research and development:• The new RoboDis: several fully autom<strong>at</strong>edrobotic system (equipped with HPLC-, UV/VIS- and fibre optics technology) developed<strong>in</strong> cooper<strong>at</strong>ion with ERWEKA• Several semi-autom<strong>at</strong>ed UV/VIS systems• Semi-autom<strong>at</strong>ed ”Paddle-over disk”dissolution system• Fully autom<strong>at</strong>ed Sotax AT 70 smartdissolution systemsThere will be a bus transfer to <strong>the</strong> labor<strong>at</strong>ory and back to <strong>the</strong> hotel.The number of participants for <strong>the</strong> lab visit is limited.• Various semi-autom<strong>at</strong>ed HPLC-systems
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