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Título del documento Note for Guidance on the Clinical Investigation of Plasma derived Antithrombin Products.
Titre du document Note for Guidance on the Clinical Investigation of Plasma derived Antithrombin Products.

Título del documento Points to consider on the clinical development of fibrinolytic medicinal products in the treatment of patients with ST segment elevation acute myocardial infarction(STEMI) Note for Guidance on the clinical development of medicinal products for the treatment of HIV infection.
Titre du document Points to consider on the clinical development of fibrinolytic medicinal products in the treatment of patients with ST segment elevation acute myocardial infarction(STEMI) Note for Guidance on the clinical development of medicinal products for the treatment of HIV infection.

Note for Guidance on the Clinical investigation of recombinant factor VIII and IX products Adoptada en octubre de 2000.
Note for Guidance on the Clinical investigation of recombinant factor VIII and IX products Adoptée en octobre 2000.

CPMP/ EWP/ 225/ 02 Concept paper on the development of a CPMP Note for Guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal failure.
Titre du document Concept paper on the development of a CPMP Note for Guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal failure.

Note for Guidance on the Clinical investigation of human plasma derived factor VIII and IX products Adoptada en octubre de 2000.
Note for Guidance on the Clinical investigation of human plasma derived factor VIII and IX products Adoptée en octobre 2000.

Core SPC for Human albumin Publicada para consulta en junio de 2000 Note for Guidance on the Clinical investigation of plasma derived antithrombin products Publicada para consulta en diciembre de 2000.
Core SPC for Human albumin Transmise pour consultation en juin 2000 Note for Guidance on the Clinical investigation of plasma derived antithrombin products Transmise pour consultation en décembre 2000.

Note for guidance on the Clinical investigation of recombinant factor VIII and IX products Publicada para consulta en junio de 2000.
Note for guidance on the Clinical investigation of recombinant factor VIII and IX products Transmise pour consultation en juin 2000.

Por otra parte, la Directriz más reciente de la UE se estableció en 1994 Note for Guidance on the evaluation on the pharmacokinetics of medicinal products in patients with imparied renal function, CHMP/ EWP/ 225/ 02.
De plus, la ligne directrice de l'UE la plus récente n'a été définie qu'en 1994 Note for Guidance on the evaluation on the pharmacokinetics of medicinal products in patients with impaired renal function[Note d'orientation sur l'évaluation de la pharmacocinétique des médicaments chez les patients dont la fonction hépatique est altérée], CHMP/ EWP/ 225/ 02.

Note for guidance on the Clinical investigation of human normal immunoglobulin for intravenous administration(IVIg) Adoptada en junio de 2000.
Note for guidance on the Clinical investigation of human normal immunoglobulin for intravenous administration(IVIg) Adoptée en juin 2000.

Título del documento Concept paper for the development of the revision of the CPMP Note for Guidance on evaluation of new anti- bacterial medicinal products(CPMP/ EWP/ 558/ 95) and the CPMP Note for Guidance on the pharmacodynamic section of the SPC for anti-bacterial medicinal products CPMP/ EWP/ 520/ 96.
Titre du document Concept paper for the development of the revision of the CPMP Note for Guidance on evaluation of new anti- bacterial medicinal products(CPMP/ EWP/ 558/ 95) and the CPMP Note for Guidance on the pharmacodynamic section of the SPC for anti-bacterial medicinal products CPMP/ EWP/ 520/ 96.

Título del documento Note for Guidance on the clinical investigation of human normal immunoglobulin for subcutaneous and intramuscular use.
Titre du document Note for Guidance on the clinical investigation of human normal immunoglobulin for subcutaneous and intramuscular use.

Note for guidance on the Clinical investigation of human anti-D immunoglobulin for intravenous and/or intramuscular use Adoptada en junio de 2000.
Note for guidance on the Clinical investigation of human anti-D immunoglobulin for intravenous and/or intramuscular use Adoptée en juin 2000.

Concept paper on the Development of a CPMP Note for Guidance on the Clinical investigation of medicinal products in pain management Adoptada en junio de 2000.
Concept paper on the Development of a CPMP Note for Guidance on the Clinical investigation of medicinal products in pain management Adoptée en juin 2000.

Note for Guidance on the production and quality control of animal immunoglobulins and immunosera for human use Publicada para consulta en enero de 2000.
Note for Guidance on the production and quality control of animalimmunoglobulins and immunosera for human use Transmise pour consultation en janvier 2000.

Concept paper on the development of a CPMP Note for Guidance on the clinical investigation of medicinal products in the treatment of asthma Adoptada en febrero de 2000.
Concept paper on the development of a CPMP Note for Guidance on the clinical investigation of medicinal products in the treatment of asthma Adoptée en février 2000.

Note for guidance on the maximum shelf life for Publicada para consulta en abril de 1999 sterile veterinary medicinal products after first opening or following reconstitution.
Note for guidance on the maximum shelf life for sterile veterinary medicinal products after first opening or following reconstitution.

Core SPC for Human albumin Adoptada en octubre de 2000 Note for guidance on the Clinical investigation of human plasma derived factor VIII and IX products Publicada para consulta en junio de 2000.
Core SPC for Human albumin Adoptée en octobre 2000 Note for guidance on the Clinical investigation of human plasma derived factor VIII and IX products Transmise pour consultation en juin 2000.

Note for Guidance on the investigation of bioavailability and bioequivalence Publicada para consulta en diciembre de 2000 Note for Guidance on co-ordinating investigator signature of clinical study reports Publicada para consulta en diciembre de 2000.
Note for Guidance on the investigation of bioavailability and bioequivalence Transmise pour consultation en décembre 2000 Note for Guidance on co-ordinating investigator signature of clinical study reports Transmise pour consultation en décembre 2000.

Dicho estudio debía cumplir con la Note for Guidance on the Clinical Investigation of Medicinal Products in the Treatment of Asthma CPMP/ EWP/ 2922/ 01.
Une étude de ce type doit satisfaire aux exigences de la note explicative sur l'étude clinique des médicaments destinés au traitement de l'asthme« NfG on the Clinical Investigation of Medicinal Products in the Treatment of Asthma» CPMP/ EWP/ 2922/ 01.

Título del documento Note for Guidance on the Clinical investigation of plasma derived fibrin sealants Note for guidance on the Clinical investigation of von Willebrand factor Warning on transmissible agents for patient leaflets and SPCs Core SPC for Plasma derived fibrin sealants.
Titre du document Note for Guidance on the Clinical investigation of plasma derived fibrin sealants Note for guidance on the Clinical investigation of von Willebrand factor Warning on transmissible agents for patient leaflets and SPCs Core SPC for Plasma derived fibrin sealants.

Empleando el"método alternativo" que cita el CVMP en su Note for guidance on the approach towards harmonisation of withdrawal periods(EMEA/ CVMP/ 036/ 95) se obtiene un período de espera de 16 días después de añadir un"factor de incertidumbre" del 10.
En utilisant la« méthode alternative», comme énoncé dans le document d'orientation du CVMP sur la méthode d'harmonisation des délais d'attente(EMEA/ CVMP/ 036/ 95), un délai d'attente de 16 jours est obtenu après ajout d'un« facteur d'incertitude» de 10.

Título del documento Revision of Note for guidance on the conduct of pharmacovigilance for centrally authorised products Revision of crisis management plan regarding centrally authorised products for human use Guidance document for the implementation of the position paper on compliance with pharmacovigilance regulatory obligations Contribution to Note for guidance on the use of medicinal products during pregnancy.
Titre du document Revision of Note for guidance on the conduct of pharmacovigilance for centrally authorised products Revision of crisis management plan regarding centrally authorised products for human use Guidance document for the implementation of the position paper on compliance with pharmacovigilance regulatory obligations Contribution to Note for guidance on the use of medicinal products during pregnancy.

Empleando el"método alternativo" que cita el CVMP en su Note for guidance on the approach towards harmonisation of withdrawal periods"Guía sobre el método de armonización de los tiempos de espera"(EMEA/ CVMP/ 036/ 95) se obtiene un período de espera de 8 días después de añadir un" factor de incertidumbre"del 10.
En utilisant la« méthode alternative», comme énoncé dans le document d'orientation du CVMP sur la méthode d'harmonisation des délais d'attente(EMEA/ CVMP/ 036/ 95), un délai d'attente de 8 jours est obtenu après ajout d'un« facteur d'incertitude» de 10.

Título del documento Note for Guidance on the Use of Bovine Serum in the manufacture of Human Biological Medicinal Products Points to Consider on Quality Aspects of Medicinal Products containing Active Substances Produced by Stable Transgene Expression in Higher Plants Revision of Note for guidance on minimising the risks of TSE transmission via medicinal products Points to Consider on the Development of Live Attenuated Influenza Vaccines.
Titre du document Note for Guidance on the Use of Bovine Serum in the manufacture of Human Biological Medicinal Products Points to Consider on Quality Aspects of Medicinal Products containing Active Substances Produced by Stable Transgene Expression in Higher Plants Revision of Note for guidance on minimising the risks of TSE transmission via medicinal products Points to Consider on the Development of Live Attenuated Influenza Vaccines.

¿Considera necesario el BPWP la elaboración de una Note for Guidance on the Clinical Investigation of Human Plasma derived Hepatitis-B Immunoglobulins específica para describir los requisitos relacionados especialmente con el diseño de los estudios clínicos y los datos de seguridad necesarios para las indicaciones propuestas?
Le BPWP juge -t-il nécessaire d'élaborer une note d'orientation spécifique pour les études cliniques des immunoglobulines anti-hépatite B dérivées de plasma humain pour exposer les grandes lignes des exigences notamment en ce qui concerne la conception des études cliniques et les données de sécurité requises pour les indications revendiquées?

Note for Guidance on Clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease Publicada para consulta en noviembre de 2000.
Note for Guidance on Clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease Transmise pour consultation en novembre 2000.

Concept Paper on the Development of a CPMP/CVMP Note for Guidance on Quality of Water for Pharmaceutical Use Adoptada en julio de 2000.
Concept Paper on the Development of a CPMP/CVMP Note for Guidance on Quality of Water for Pharmaceutical Use Adoptée en juillet 2000.

Concept paper on the Development of a CPMP Note for Guidance on Clini- cal investigation of medicinal products in the treatment of diabetes mellitus Adoptada en julio de 2000.
Concept paper on the Development of a CPMP Note for Guidance on Clini- cal investigation of medicinal products in the treatment of diabetes mellitus Adoptée en juillet 2000.

Título del documento Position Paper on the Non-clinical safety studies to support clinical trials with a single low dose of a compound Note for Guidance on specification limits for residues of metal catalysts Note for Guidance on Comparability of Medicinal Products Containing Biotechnology-derived Proteins as Drug Substance.
Titre du document Position Paper on the Non-clinical safety studies to support clinical trials with a single low dose of a compound Note for Guidance on specification limits for residues of metal catalysts Note for Guidance on Comparability of Medicinal Products Containing Biotechnology-derived Proteins as Drug Substance.

Un documento importante que se está actualizando es el titulado Preliminary Guidance Notes on Sample Preparation and Dosimetry for the Safety Testing of Manufactured Nanomaterials(notas preliminares de orientación sobre la preparación y la dosimetría para ensayos de seguridad de los nanomateriales manufacturados), actividad cuya importancia se ha considerado crucial en vista de las nuevas iniciativas derivadas del programa de patrocinio.
Un important document, actuellement en cours de mise à jour, s' intitulé Guidance Notes On Sample Preparation And Dosimetry for The Safety Tasting of Manufactured Nanomaterials,( Note d' orientation préliminaire sur la préparation des échantillons et la dosimétrie, aux fins d' essais sans danger des nanomatériaux manufacturés); cette activité a été considérée comme essentielle à la lumière des nouveaux travaux résultant du programme de parrainage.

Comment utiliser "note for guidance on the" dans une phrase

Revision 6 of Note for Guidance on the evaluation of anticancer medicinal products in man.

CPMP Note for guidance on the evaluation of medicinal products for treatment of bacterial infections.

Committee for Proprietary Medicinal Products (2001) Note for guidance on the investigation of bioavailability and bioequivalence.

Note for guidance on the inclusion of appendices to clinical study reports in marketing authorisation applications. 2004.

Note for guidance on the use of bovine serum in the manufacture of human biological medicinal products.

Note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function.

This study was designed according to the note for guidance on the clinical evaluation of new vaccines .