Conditional marketing authorization (CMA) in the European Union (EU) is an early access pathway for medicines that show promising therapeutic effects, but for which comprehensive data are not available. Using a mixed quantitative-qualitative research design, we evaluated how CMA has been used in marketing authorization of oncology medicines in the period 2006 to 2013. We show that compared to full marketing authorization, CMA is granted based on less comprehensive data. However, this is accompanied by significantly longer assessment times and less consensus among regulators about marketing authorization. Moreover, development time from first-in-human testing to marketing authorization did not differ between full marketing authorization and CMA, but was significantly longer for CMA compared to accelerated approved products in the United States (US). Results indicate that CMA is not used by companies as a prospectively planned pathway to obtain early access, but as a "rescue option" when submitted data are not strong enough to justify full marketing authorization.
Tanz RD, Marcus SM (1966) Influence of endogenous cardiac catecholamine depletion on the force and rate of isolated heart preparations and their response to ouabain. J Pharamcol Exp Ther 151: 38-45 Thorpe WP (1973) Some effects of caffeine and quinidine on sarcoplasmic reticulum of skeletal and cardiac muscle. Can J Physiol Pharmacol 51: 499-503 Thyrum PT (1974) Inotropic stimuli and systolic transmembrane calcium flow in depolarized guinea pig atria. J Pharmacol Exp Ther 188: 166-179 Tillisch J, Langer GA (1974) Myocardial mechanical responses and ionic exchange in high sodium perfusate. Circ Res 34: 40-50 Tillisch JH, Fung LK, Horn PM, Langer GA (1979) Transient and steady-state effects on sodium and calcium on myocardial contractile response. J Mol Cell Cardiol 11: 137-148 Weingart R, Kaas RS, Tsien RW (1978) Is digitalis inotropy associated with enhanced slow inward calcium current? Nature 217:389-392 Weiss R, Tritthart H, Walter B (1974) Correlation of Na-withdrawal effects on Ca-mediated action potentials and contractile activity in cat ventricular myocardium. Pfluegers Arch 350: 299-307 Wendt IR, Langer GA (1977) The sodium-calcium relationship in mammalian myocardium. Effects of sodium deficient perfusion on calcium fluxes. J Mol CellSUMMARY We compared pump function of left and right ventricles in isolated ejecting cat hearts in which the natural series arrangement between the two sides of the heart was broken. The relationship between mean ventricular pressure and output obtained by varying the arterial load, the so-called pump function graph, and the mean external power output found at the various load levels, was taken as the basis for the comparison. The way in which pressures and flow generated by the right ventricle are changed by alterations in resistance and compliance of the loading arterial system, is qualitatively similar to what has been found in a previous study for the left side of the heart, in spite of the structural differences. The right ventricular pump function curve differs from the left ventricular curve in the absolute scale for the mean pressure axis, but if the scale is adjusted appropriately, the two curves look alike. Both ventricles appear matched to the input impedances of their respective arterial systems because both of them generate the maximum external power under the normal loading conditions. Right ventricular pump function is dependent on the left ventricular contraction mode. The presence of an isovolumic beat on the left side of the heart enhances right ventricular pump function. This is in contrast to the very small effect of the right ventricular contraction pattern on the pump function of the left side of the heart. Circ Res 46: 564-574, 1980STRIKING differences exist between the right and left sides of the heart. However, both ventricles have approximately the same output because of their series arrangement, and both are part of the same muscular structure, the heart. In spite of this tight connection, the two sides must have different pump characteristics refle...
Given the high prevalence of mental health problems, psychosocial programmes for large refugee populations should aim at strengthening community structures and supporting groups instead of focusing at individuals. The screening capacity of the GHQ-28 could be used to identify mentally vulnerable groups.
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