Asked | Open questions | Answered Points Date Pair Term / Answer given Level Status Gloss 4 Oct 20 '22 eng>deu reimbursement process Verfahren zur Zusatznutzenbewertung pro closed ok - Oct 20 '22 eng>deu mandatory benefit dossier obligatorische Nutzenbewertung pro closed ok - Feb 12 '21 eng>deu thorough QT study spezielle QT-Studie pro closed no 4 Jan 18 '21 eng>deu erixolin mesilate Eribulinmesilat pro closed ok 4 Jan 18 '21 eng>deu irinsarcan Irinotecan pro closed ok 4 Nov 11 '20 eng>deu grade Grad pro closed ok 4 Jul 8 '20 eng>deu high level flow grober/allgemeiner Ablauf pro closed ok 4 Apr 28 '20 eng>deu frontline and relapsed disease Erstdiagnose und Rezidiv pro closed ok 4 Apr 16 '20 eng>deu engineering-run (non-GMP) Test(durch)lauf pro closed ok 4 Apr 16 '20 eng>deu Research Cell Bank Forschungs-Zellbanken pro closed ok 4 Apr 15 '20 eng>deu fusion status Fusionsstatus pro closed ok 3 Feb 28 '20 deu>eng Säulenkartei column log pro closed ok 4 Nov 11 '19 eng>deu side-by-side comparison indirekter Vergleich pro closed ok 4 Jan 15 '19 eng>deu median survival follow-up s. u. pro closed ok 4 Jan 15 '19 eng>deu Tumour-to-plasma ratio Exposition des Tumors im Vergleich zur Plasmakonzentration pro closed ok 4 Oct 8 '18 eng>deu milk-plasma-ratio Milch/Plasma-Quotient pro closed ok - Nov 20 '17 eng>deu barrier room Schleuse pro closed no - Jul 14 '17 eng>deu on-drug and new patients s.u. pro closed ok 4 May 5 '17 eng>deu discovery stage programs s. u. pro closed ok 4 Feb 24 '17 deu>eng Fixkombi fixed dose combination pro closed ok 4 Jan 6 '17 eng>deu down titration schrittweise Dosisreduktion pro closed ok 4 Jan 6 '17 eng>deu proposed mechanism der wahrscheinliche Wirkmechanismus pro closed ok - Jul 23 '16 deu>eng ICH Richtlinien WA ICH/GMP guidelines for... pro just_closed no 4 Jul 9 '16 deu>eng Wirk- und/oder Zulassungsmodell s. u. pro closed ok 4 Nov 11 '15 eng>deu minimal particulars to appear on blisters or strips MINDESTANGABEN AUF BLISTERPACKUNGEN ODER FOLIENSTREIFEN pro closed ok 4 Aug 12 '15 eng>deu a population pharmacokinetic-pharmacodynamic modelling approach ein populationsbasierter Ansatz mit PK/PD-Modell(ierung) pro closed ok 4 Jul 24 '15 deu>eng Bei unzureichender Wirksamkeit lack of efficacy/response pro closed ok 4 Jun 29 '15 eng>deu best and base median bester und Basis-(PFS-)Medianwert pro closed ok 4 Jun 11 '15 eng>deu multi-target medicine Arzneimittel mit mehreren Indikationen pro closed ok 4 May 23 '15 eng>deu NO regular medications (NO medications (TO BE) taken on a regular basis) keine regelmäßige Einnahme von Medikamenten pro closed ok - May 19 '15 deu>eng Arzneimittelumstellung change/adjustment of medication (regimen) pro closed no 4 May 5 '15 deu>eng retard extended release pro closed ok 4 Apr 10 '15 eng>deu gated (sequential gated) gestaffelt pro closed ok 4 Mar 24 '15 eng>deu initial responders at Week 16 s. u. pro closed no 4 Mar 6 '15 eng>deu in the source in den Quelldokumenten pro closed ok - Jan 29 '15 eng>deu single affinity class of receptors Affinität für eine einzelne/einzige Rezeptorklasse pro closed ok 4 Dec 5 '14 eng>deu q4 week alle 4 Wochen pro closed ok 4 Nov 3 '14 eng>deu on-target and off-target effects erwünschte und unerwünschte Effekte/Wirkungen pro closed ok 4 Oct 16 '14 eng>deu Second Mitochondrial Activator of Caspases-mimetic SMAC-Mimetikum pro closed ok 4 Aug 11 '14 deu>eng RESTSAUERSTOFFMESSUNG IM GASRAUM residual oxygen measurement pro closed ok - Aug 6 '14 eng>deu replacement/stress corticosteroids Kortikoide als Ersatz- oder Notfallmedikation pro closed ok 4 Aug 4 '14 eng>deu role functioning Rollenfunktion / Rollenfunktionalität pro closed ok 4 Jul 29 '14 eng>deu microbial excursions mikrobiologische Abweichungen pro closed ok 4 Jul 24 '14 deu>eng unterhalb downstream pro closed ok 4 Jul 23 '14 deu>eng im (here) in relapsed patients pro closed ok 4 Jul 10 '14 fra>deu dispositif de perfusion Infusionsset pro closed ok 4 Jul 6 '14 deu>eng zum Einnehmen for oral use/administration pro closed ok 4 Jul 4 '14 eng>deu germ-line-encoded keimbahnkodiert pro closed ok 4 Jun 18 '14 deu>eng ZNS-gängig does it cross/pass the blood-brain barrier? pro closed ok 4 Feb 19 '14 eng>deu side sample Begleitprobe pro closed ok Asked | Open questions | Answered