{"id":39514,"date":"2024-07-15T13:57:41","date_gmt":"2024-07-15T13:57:41","guid":{"rendered":"https:\/\/ibima.eu\/?p=39514"},"modified":"2024-07-15T13:57:45","modified_gmt":"2024-07-15T13:57:45","slug":"tinn","status":"publish","type":"post","link":"https:\/\/ibima.eu\/en\/tinn\/","title":{"rendered":"TINN"},"content":{"rendered":"[et_pb_section fb_built=\u00bb1″ _builder_version=\u00bb4.25.0″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_row _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_column type=\u00bb4_4″ _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_heading title=\u00bbFLUCONAZOLE VS MICAFUNGIN IN NEONATES WITH SUSPECTED OR CULTURE PROVEN CANDIDIASIS: A RANDOMIZED PHARMACOKINETIC AND SAFETY STUDY\r\u00bb _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb title_font=\u00bb||||||||\u00bb title_text_align=\u00bbcenter\u00bb title_text_color=\u00bb#0C71C3″ module_alignment=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][\/et_pb_heading][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00bb2_3,1_3″ _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb custom_padding=\u00bb30px||||false|false\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_column type=\u00bb2_3″ _builder_version=\u00bb4.25.0″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_text _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]
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Financed by<\/strong>\u00a0: European Commission<\/span><\/p>\n

Program<\/strong>\u00a0: HEALTH-2007-4.2-1 \u2013 Adapting off-patent medicines to the specific needs of pediatric populations<\/span><\/p>\n

Grant Agreement ID:<\/b><\/span>\u00a0<\/span>223614<\/a><\/span><\/p>\n

Role in the project:<\/strong>\u00a0Collaborator<\/span><\/p>\n

Duration:<\/span><\/b>\u00a0November 2008 to October 2015<\/span><\/span><\/p>\n

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Contact:\u00a0Lucena Gonz\u00e1lez, Mar\u00eda Isabel<\/span><\/p>\n

Implementation Centre:<\/span>\u00a0Virgen de la Victoria University Hospital<\/a><\/span><\/p>\n

Research group of IBIMA involved:<\/span>\u00a0Hepatogastroenterology, Pharmacology and Clinical Translational Therapeutics<\/a><\/span><\/p>\n

 <\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_3″ _builder_version=\u00bb4.25.0″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_post_title title=\u00bboff\u00bb meta=\u00bboff\u00bb image_height=\u00bb1000px\u00bb image_max_height=\u00bb212px\u00bb admin_label=\u00bbT\u00edtulo de publicaci\u00f3n\u00bb _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb title_font=\u00bbArial||||||||\u00bb title_text_align=\u00bbcenter\u00bb title_text_color=\u00bb#2ea3f2″ title_font_size=\u00bb35px\u00bb meta_text_align=\u00bbcenter\u00bb background_enable_color=\u00bboff\u00bb background_enable_image=\u00bboff\u00bb text_orientation=\u00bbcenter\u00bb width=\u00bb100%\u00bb max_width=\u00bb100%\u00bb module_alignment=\u00bbcenter\u00bb min_height=\u00bb100px\u00bb height=\u00bb103px\u00bb max_height=\u00bb100px\u00bb custom_margin=\u00bb15%||1%||false|false\u00bb hover_enabled=\u00bb0″ title_font_size_last_edited=\u00bboff|desktop\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb sticky_enabled=\u00bb0″][\/et_pb_post_title][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb custom_margin=\u00bb-38px||-50px||false|false\u00bb custom_padding=\u00bb50px||50px||true|false\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_column type=\u00bb4_4″ _builder_version=\u00bb4.25.0″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_heading title=\u00bbABSTRACT\u00bb _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb title_font=\u00bb||||||||\u00bb title_text_color=\u00bb#0C71C3″ global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][\/et_pb_heading][et_pb_text _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb custom_margin=\u00bb0px||19px||false|false\u00bb hover_enabled=\u00bb0″ global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb sticky_enabled=\u00bb0″]

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The aim of TINN is to evaluate ciprofloxacin, fluconazole and micafungin in neonates; two anti-infectious drugs included in the EMEA priority list of the therapeutic areas that need specific drug evaluation in preterm and term neonates. These drugs are prescribed off-label to treat neonatal infections that are life threatening situations and associated with long-term complications. In order to validate the use of these two drugs in these high risk populations, TINN involves European leaders in neonatology, paediatric pharmacology, methodology and SME and has established a close collaboration between academia, ethical bodies, regulatory authorities and pharmaceutical companies. For both drugs, the project will perform in silico experimentations, animal studies and evaluate formulations adapted to neonates.<\/span><\/p>\n

Designs will be optimized using age-appropriate state-of-the-art methods adapted to neonates, include pharmacokinetics and pharmacogenetics in order to validate the components of a Paediatric Investigation Plan. The two trials will be performed with neonatologists trained in paediatric pharmacology and clinical research who respect Good Clinical Practices. All the ethical issues related to the two trials will be considered in particular pain and distress, blood sampling (number and volume) and informed consent. Parent information sheets and consent form submitted to parents\u2019 associations for approval. TINN will include short-term safety (based on vital signs, blood safety data and function of the major organs) and potential for long-term adverse reactions. Results will be also reported in order to allow a PUMA application and to improve neonatal care, through scientific societies. Therefore, TINN will strengthen the European role in drug evaluation in paediatric patients and will support initiatives of the European pharmaceutical industry. Increasing the appropriate use of medicines in child will be of direct benefit to children, their families and health professionals.<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]","protected":false},"excerpt":{"rendered":"

Financed by\u00a0: European Commission Program\u00a0: HEALTH-2007-4.2-1 \u2013 Adapting off-patent medicines to the specific needs of pediatric populations Grant Agreement ID:\u00a0223614 Role in the project:\u00a0Collaborator Duration:\u00a0November 2008 to October 2015 \u00a0 Contact:\u00a0Lucena Gonz\u00e1lez, Mar\u00eda Isabel Implementation Centre:\u00a0Hospital Universitario Virgen de la Victoria Research group of IBIMA involved:\u00a0Hepatogastroenterology, Pharmacology and Clinical Translational Therapeutics   The aim of […]<\/p>","protected":false},"author":3,"featured_media":39517,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[2191],"tags":[],"class_list":["post-39514","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-proyectos-de-investigacion"],"acf":[],"yoast_head":"\nTINN - 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