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points to consider on biostatistical/ methodological issues arising from cpmp discussion on licensing applications:
points to consider on the use of statistical methods for flexible design and analysis of confirmatory clinical trials points to consider on clinical pharmacokinetic investigation of

adjustment for multiplicity and related topics points to consider on biostatistical/ methodological issues arising from cpmp discussion on licensing applications:
adjustment for multiplicity and related topics points to consider on biostatistical/ methodological issues arising from cpmp discussion on licensing applications:

choice of non-inferiority margin points to consider on biostatistical/methodological issues arising from cpmp discussion on licensing applications:
from cpmp discussion on licensing applications:choice of non-inferiority marginpoints to consider on biostatistical/methodological issues arising from cpmp discussion on licensing applications:adjustment for

concept paper on the development of a cpmp points to consider on biostatistical/methodological issues arising from cpmp discussions on licensing applications: adjustment for baseline covariates adoptada en febrero de 2000
points to consider concerning endpoints in clinical studies with haematopoietic growth factors for mobilisation of autologous stem cells adopted february 2000

46/63 grupo de trabajo del cpmp " eficacia "título del documento note for guidance on clinical investigation of medicinal products for the treatment of diabetes mellitus note for guidance on clinical investigation of anti-depressive agents note for guidance on clinical investigation of medicinal products for pain treatment position paper on new modified formulations of acetyl salicylic acid in the secondary prevention of cardiovascular events note for guidance on clinical investigation of medicinal products for treatment of peripheral arterial occlusive disease concept paper on the revision of the note for guidance on evaluation of new anti-bacterial medicinal product (cpmp/ewp/558/95) and the note for guidance on the pharmacodynamic section of the summary of product characteristics for antibacterial products points to consider on biostatistical/methodological issues arising from cpmp discussion on licensing applications:
emea 2002 emea/mb/049/01-en-finalwork progamme for 2002 cpmp efficacy working party document title note for guidance on clinical investigation of medicinal products for the treatment of diabetes mellitus note for guidance on clinical investigation of anti-depressive agents note for guidance on clinical investigation of medicinal products for pain treatment position paper on new modified formulations of acetyl salicylic acid in the secondary prevention of cardiovascularpage 45/62events note for guidance on clinical investigation of medicinal products for treatment of peripheral arterial occlusive disease concept paper on the revision of the note for guidance on evaluation of new anti-bacterial medicinal product (cpmp/ewp/558/95) and the note for guidance on the pharmacodynamic section of the summary of product characteristics for antibacterial products points to consider on biostatistical/methodological issues arising from cpmp discussion on licensing applications: