<\/strong><\/span><\/h4>\n<\/strong><\/span><\/h4>\nProf. Dr. Ancuceanu Robert<\/strong><\/span>
U.M.F. “Carol Davila”, Bucure\u015fti<\/strong><\/span><\/h4>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.25″ locked=”off”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.9.6″]<\/p>\n
Dezvoltarea de medicamente pentru epidermoliza buloas\u0103<\/span>
Autori: R. Ancuceanu, Mihaela Dinu<\/span><\/p>\nCuvinte cheie: Epidermoliza buloas\u0103, medicamente orfane, studii clinice<\/span><\/p>\nObiective: Epidermoliza buloas\u0103 reprezint\u0103 un grup heterogen de afec\u0163iuni cutanate de natur\u0103 genetic\u0103, rare \u015fi nevindecabile, cauzate de muta\u0163ii ale unor gene codific\u00e2nd proteine structurale cheie din piele. Care afec\u021biuni ar trebui incluse \u00een cadrul spectrului cunoscut generic drept \u201eepidermoliz\u0103 buloas\u0103\u201c \u0219i care nu, r\u0103m\u00e2ne o chestiune deschis\u0103. Cum aceste maladii sunt rare, ne-am propus identificarea medicamentelor desemnate ca orfane p\u00e2n\u0103 \u00een prezent \u0219i a provoc\u0103rilor pe care le prezint\u0103 dezvoltarea acestei categorii de medicamente.<\/span>
Materiale \u0219i metode: s-au examinat toate medicamentele \u00eenregistrate \u00een Registrul Uniunii Europene de medicamente orfane \u0219i \u00een web-site-ul FDA \u0219i s-au c\u0103utat informa\u021bii despre stadiul de dezvoltare clinic\u0103 al medicamentelor respective. De asemenea, printr-o interogare Medline s-au identificat studii clinice publicate p\u00e2n\u0103 \u00een prezent \u00een diverse forme de epidermoliz\u0103 buloas\u0103. Interog\u0103ri relevante au permis identificarea de studii clinice \u00een derulare sau ale c\u0103ror rezultate nu au fost \u00eenc\u0103 publicate.<\/span>
Rezultate: \u00cen Registrul Uniunii Europene de medicamente orfane s-au identificat un num\u0103r de 21 de intr\u0103ri (cel pu\u0163in dou\u0103 sunt duplicate), dintre care 20 se refer\u0103 la \u201etratamentul epidermoliezei buloase\u201c (f\u0103r\u0103 alte calificative sau identificatori), iar unul la tratamentul epidermolizei buloase distrofice. \u00cen SUA num\u0103rul medicamentelor orfane indicate pentru aceste grup de afec\u021biuni este ceva mai mare (25, dintre care cel pu\u021bin un duplicat \u0219i dou\u0103 retrase) \u0219i numai aproape jum\u0103tate sunt desemnate generic \u00een \u201eepidermoliza buloas\u0103\u201c.<\/span><\/p>\n\n
Developing drugs for epidermolysis bullosa<\/span>
Autori: R. Ancuceanu, Mihaela Dinu<\/span><\/p>\nKeywords: Epidermolysis bullosa, orphan medicines, clinical trials<\/span><\/p>\nObjectives: Epidermolysis bullosa is a heterogeneous group of skin disorders of genetic nature, rare and incurable, caused by mutations in genes encoding key structural proteins in the skin. Which conditions should be included within the spectrum known generically as “epidermolysis bullosa” and which should not, remains an open question. As these diseases are rare, we set out to identify which drugs have been designated as orphan drugs to date and the challenges of developing this category of drugs.<\/span>
Materials and methods: All drugs registered in the European Union Register of Orphan Medicinal Products and on the FDA website were reviewed and information on the clinical development status of these drugs was sought. A Medline search also identified clinical trials published to date in various forms of epidermolysis bullosa. Relevant queries identified ongoing clinical trials or trials whose results have not yet been published.<\/span>
Results: A total of 21 entries were identified in the European Union Register of Orphan Medicinal Products (at least two are duplicates), of which 20 refer to the “treatment of epidermolysis bullosa” (with no other qualifiers or identifiers) and one to the treatment of dystrophic epidermolysis bullosa. In the US the number of orphan drugs indicated for this group of conditions is somewhat higher (25, of which at least one duplicate and two withdrawn) and only about half are generically designated in “epidermolysis bullosa”.<\/span><\/p>\nScurt CV<\/span><\/p>\nRobert Ancuceanu este profesor \u015fi prodecan \u00een cadrul Facult\u0103\u0163ii de Farmacie din Bucure\u015fti, disciplina Botanic\u0103 farmaceutic\u0103 \u015fi biologie celular\u0103. Cu un doctorat \u00een farmacie, un masterat \u00een biostatistic\u0103 \u015fi licen\u0163\u0103 \u00een drept, a lucrat \u00een diferite domenii farmaceutice, de la cel academic la cel industrial \u015fi \u00een cadrul autorit\u0103\u0163ilor de reglementare. A fost director general al Direc\u0163iei Generale Farmaceutice \u015fi Aparatur\u0103 Medical\u0103 din Ministerul S\u0103n\u0103t\u0103\u0163ii \u015fi Vicepre\u015fedinte al Agen\u0163iei Na\u0163ionale a Medicamentului. A fost membru al Comitetului pentru Medicamente de Uz Uman (CHMP) \u015fi al Comitetului Pediatric (PDCO) \u015fi membru altern (supleant) al Comitetului pentru Medicamente pe baz\u0103 de Plante din cadrul Agen\u0163iei Europene a Medicamentului (EMA), precum \u015fi membru \u00een mai multe comitete sau grupuri de lucru din domeniul farmaceutic. A publicat 56 articole \u015ftiin\u0163ifice indexate ISI, este autor a dou\u0103 c\u0103r\u0163i \u015fi co-autor la alte patru. Pe l\u00e2ng\u0103 interesul s\u0103u larg pentru toate aspectele domeniului farmaceutic, Robert se consider\u0103 un renascentist \u00eent\u00e2rziat, fiind interesat \u015fi de drept, istorie, muzic\u0103, biostatistic\u0103 \u0219i machine learning, sociologie \u015fi literatur\u0103.<\/span><\/p>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.9.6″ background_color=”rgba(117,194,33,0.23)” background_image=”https:\/\/pdi.ro\/2021\/wp-content\/uploads\/2021\/05\/PDI2021_header_1920x550px.jpg” background_blend=”multiply” custom_padding=”54px|0px|0|0px|false|false” top_divider_style=”waves2″ top_divider_color=”#ffffff” top_divider_height=”155px” top_divider_height_tablet=”” top_divider_height_phone=”97px” top_divider_height_last_edited=”on|desktop” bottom_divider_style=”waves2″ bottom_divider_color=”#75c221″ bottom_divider_flip=”vertical” bottom_divider_height_tablet=”” bottom_divider_height_phone=”59px” bottom_divider_height_last_edited=”on|desktop” saved_tabs=”all” global_module=”9177″][et_pb_row column_structure=”3_5,2_5″ _builder_version=”3.25″ custom_padding=”61px|0px|69px|0px|false|false”][et_pb_column type=”3_5″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.9.4″ text_font=”Kaushan Script||||||||” text_text_color=”#f0622a” text_font_size=”30px” text_line_height=”1.2em” header_font=”||||||||” background_layout=”dark” text_font_size_tablet=”” text_font_size_phone=”” text_font_size_last_edited=”on|desktop”]<\/p>\n
Contacteaz\u0103 operatorul PDI 2021<\/p>\n
[\/et_pb_text][et_pb_contact_form email=”contact@pdi.ro\/2021\/2019″ submit_button_text=”Trimite mesajul” _builder_version=”4.9.4″ title_font=”||||||||” custom_button=”on” button_text_color=”#F0622A”][et_pb_contact_field field_id=”Name” field_title=”Nume” _builder_version=”3.18.9″ button_text_size__hover_enabled=”off” button_one_text_size__hover_enabled=”off” button_two_text_size__hover_enabled=”off” button_text_color__hover_enabled=”off” button_one_text_color__hover_enabled=”off” button_two_text_color__hover_enabled=”off” button_border_width__hover_enabled=”off” button_one_border_width__hover_enabled=”off” button_two_border_width__hover_enabled=”off” button_border_color__hover_enabled=”off” button_one_border_color__hover_enabled=”off” button_two_border_color__hover_enabled=”off” button_border_radius__hover_enabled=”off” button_one_border_radius__hover_enabled=”off” button_two_border_radius__hover_enabled=”off” button_letter_spacing__hover_enabled=”off” button_one_letter_spacing__hover_enabled=”off” button_two_letter_spacing__hover_enabled=”off” button_bg_color__hover_enabled=”off” button_one_bg_color__hover_enabled=”off” button_two_bg_color__hover_enabled=”off”][\/et_pb_contact_field][et_pb_contact_field field_id=”Email” field_title=”Adresa de e-mail” field_type=”email” _builder_version=”3.19.4″ button_text_size__hover_enabled=”off” button_one_text_size__hover_enabled=”off” button_two_text_size__hover_enabled=”off” button_text_color__hover_enabled=”off” button_one_text_color__hover_enabled=”off” button_two_text_color__hover_enabled=”off” button_border_width__hover_enabled=”off” button_one_border_width__hover_enabled=”off” button_two_border_width__hover_enabled=”off” button_border_color__hover_enabled=”off” button_one_border_color__hover_enabled=”off” button_two_border_color__hover_enabled=”off” button_border_radius__hover_enabled=”off” button_one_border_radius__hover_enabled=”off” button_two_border_radius__hover_enabled=”off” button_letter_spacing__hover_enabled=”off” button_one_letter_spacing__hover_enabled=”off” button_two_letter_spacing__hover_enabled=”off” button_bg_color__hover_enabled=”off” button_one_bg_color__hover_enabled=”off” button_two_bg_color__hover_enabled=”off”][\/et_pb_contact_field][et_pb_contact_field field_id=”Message” field_title=”Mesajul dvs.” field_type=”text” fullwidth_field=”on” _builder_version=”3.18.9″ button_text_size__hover_enabled=”off” button_one_text_size__hover_enabled=”off” button_two_text_size__hover_enabled=”off” button_text_color__hover_enabled=”off” button_one_text_color__hover_enabled=”off” button_two_text_color__hover_enabled=”off” button_border_width__hover_enabled=”off” button_one_border_width__hover_enabled=”off” button_two_border_width__hover_enabled=”off” button_border_color__hover_enabled=”off” button_one_border_color__hover_enabled=”off” button_two_border_color__hover_enabled=”off” button_border_radius__hover_enabled=”off” button_one_border_radius__hover_enabled=”off” button_two_border_radius__hover_enabled=”off” button_letter_spacing__hover_enabled=”off” button_one_letter_spacing__hover_enabled=”off” button_two_letter_spacing__hover_enabled=”off” button_bg_color__hover_enabled=”off” button_one_bg_color__hover_enabled=”off” button_two_bg_color__hover_enabled=”off”][\/et_pb_contact_field][\/et_pb_contact_form][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.9.4″ text_font=”Kaushan Script||||||||” text_text_color=”#f0622a” text_font_size=”30px” header_font=”||||||||” background_layout=”dark”]<\/p>\n
Operatorul PDI 2021<\/p>\n
[\/et_pb_text][et_pb_text _builder_version=”4.0.11″ text_font=”||||||||”]<\/p>\n
![\"\"](\"https:\/\/pdi.ro\/2021\/wp-content\/uploads\/2020\/02\/eventer_logo_150px.png\")
<\/span><\/p>\n<\/span><\/p>\n<\/span><\/p>\nAdresa: Str. A. Panu nr. 13, Iasi<\/span>
Tel.: 0332.40.88.00-05<\/span>
E-mail: inscrieri@primaderma.ro<\/a>
<\/span>Website:\u00a0<\/span>www.eventernet.ro<\/a><\/p>\n[\/et_pb_text][et_pb_text disabled_on=”off|off|off” _builder_version=”4.0.11″ text_font=”Kaushan Script||||||||” text_text_color=”#f0622a” text_font_size=”30px” header_font=”||||||||” background_layout=”dark” locked=”off”]<\/p>\n
Parteneri Media<\/p>\n
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Prof. Dr. Ancuceanu Robert U.M.F. “Carol Davila”, Bucure\u015ftiDezvoltarea de medicamente pentru epidermoliza buloas\u0103 Autori: R. Ancuceanu, Mihaela Dinu Cuvinte cheie: Epidermoliza buloas\u0103, medicamente orfane, studii clinice Obiective: Epidermoliza buloas\u0103 reprezint\u0103 un grup heterogen de afec\u0163iuni cutanate de natur\u0103 genetic\u0103, rare \u015fi nevindecabile, cauzate de muta\u0163ii ale unor gene codific\u00e2nd proteine structurale cheie din piele. Care […]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"class_list":["post-7459","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/pdi.ro\/2021\/wp-json\/wp\/v2\/pages\/7459","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdi.ro\/2021\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/pdi.ro\/2021\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/pdi.ro\/2021\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/pdi.ro\/2021\/wp-json\/wp\/v2\/comments?post=7459"}],"version-history":[{"count":8,"href":"https:\/\/pdi.ro\/2021\/wp-json\/wp\/v2\/pages\/7459\/revisions"}],"predecessor-version":[{"id":9572,"href":"https:\/\/pdi.ro\/2021\/wp-json\/wp\/v2\/pages\/7459\/revisions\/9572"}],"wp:attachment":[{"href":"https:\/\/pdi.ro\/2021\/wp-json\/wp\/v2\/media?parent=7459"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
Prof. Dr. Ancuceanu Robert<\/strong><\/span>
U.M.F. “Carol Davila”, Bucure\u015fti<\/strong><\/span><\/h4>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.25″ locked=”off”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.9.6″]<\/p>\n
Dezvoltarea de medicamente pentru epidermoliza buloas\u0103<\/span>
Autori: R. Ancuceanu, Mihaela Dinu<\/span><\/p>\nCuvinte cheie: Epidermoliza buloas\u0103, medicamente orfane, studii clinice<\/span><\/p>\nObiective: Epidermoliza buloas\u0103 reprezint\u0103 un grup heterogen de afec\u0163iuni cutanate de natur\u0103 genetic\u0103, rare \u015fi nevindecabile, cauzate de muta\u0163ii ale unor gene codific\u00e2nd proteine structurale cheie din piele. Care afec\u021biuni ar trebui incluse \u00een cadrul spectrului cunoscut generic drept \u201eepidermoliz\u0103 buloas\u0103\u201c \u0219i care nu, r\u0103m\u00e2ne o chestiune deschis\u0103. Cum aceste maladii sunt rare, ne-am propus identificarea medicamentelor desemnate ca orfane p\u00e2n\u0103 \u00een prezent \u0219i a provoc\u0103rilor pe care le prezint\u0103 dezvoltarea acestei categorii de medicamente.<\/span>
Materiale \u0219i metode: s-au examinat toate medicamentele \u00eenregistrate \u00een Registrul Uniunii Europene de medicamente orfane \u0219i \u00een web-site-ul FDA \u0219i s-au c\u0103utat informa\u021bii despre stadiul de dezvoltare clinic\u0103 al medicamentelor respective. De asemenea, printr-o interogare Medline s-au identificat studii clinice publicate p\u00e2n\u0103 \u00een prezent \u00een diverse forme de epidermoliz\u0103 buloas\u0103. Interog\u0103ri relevante au permis identificarea de studii clinice \u00een derulare sau ale c\u0103ror rezultate nu au fost \u00eenc\u0103 publicate.<\/span>
Rezultate: \u00cen Registrul Uniunii Europene de medicamente orfane s-au identificat un num\u0103r de 21 de intr\u0103ri (cel pu\u0163in dou\u0103 sunt duplicate), dintre care 20 se refer\u0103 la \u201etratamentul epidermoliezei buloase\u201c (f\u0103r\u0103 alte calificative sau identificatori), iar unul la tratamentul epidermolizei buloase distrofice. \u00cen SUA num\u0103rul medicamentelor orfane indicate pentru aceste grup de afec\u021biuni este ceva mai mare (25, dintre care cel pu\u021bin un duplicat \u0219i dou\u0103 retrase) \u0219i numai aproape jum\u0103tate sunt desemnate generic \u00een \u201eepidermoliza buloas\u0103\u201c.<\/span><\/p>\n\n
Developing drugs for epidermolysis bullosa<\/span>
Autori: R. Ancuceanu, Mihaela Dinu<\/span><\/p>\nKeywords: Epidermolysis bullosa, orphan medicines, clinical trials<\/span><\/p>\nObjectives: Epidermolysis bullosa is a heterogeneous group of skin disorders of genetic nature, rare and incurable, caused by mutations in genes encoding key structural proteins in the skin. Which conditions should be included within the spectrum known generically as “epidermolysis bullosa” and which should not, remains an open question. As these diseases are rare, we set out to identify which drugs have been designated as orphan drugs to date and the challenges of developing this category of drugs.<\/span>
Materials and methods: All drugs registered in the European Union Register of Orphan Medicinal Products and on the FDA website were reviewed and information on the clinical development status of these drugs was sought. A Medline search also identified clinical trials published to date in various forms of epidermolysis bullosa. Relevant queries identified ongoing clinical trials or trials whose results have not yet been published.<\/span>
Results: A total of 21 entries were identified in the European Union Register of Orphan Medicinal Products (at least two are duplicates), of which 20 refer to the “treatment of epidermolysis bullosa” (with no other qualifiers or identifiers) and one to the treatment of dystrophic epidermolysis bullosa. In the US the number of orphan drugs indicated for this group of conditions is somewhat higher (25, of which at least one duplicate and two withdrawn) and only about half are generically designated in “epidermolysis bullosa”.<\/span><\/p>\nScurt CV<\/span><\/p>\nRobert Ancuceanu este profesor \u015fi prodecan \u00een cadrul Facult\u0103\u0163ii de Farmacie din Bucure\u015fti, disciplina Botanic\u0103 farmaceutic\u0103 \u015fi biologie celular\u0103. Cu un doctorat \u00een farmacie, un masterat \u00een biostatistic\u0103 \u015fi licen\u0163\u0103 \u00een drept, a lucrat \u00een diferite domenii farmaceutice, de la cel academic la cel industrial \u015fi \u00een cadrul autorit\u0103\u0163ilor de reglementare. A fost director general al Direc\u0163iei Generale Farmaceutice \u015fi Aparatur\u0103 Medical\u0103 din Ministerul S\u0103n\u0103t\u0103\u0163ii \u015fi Vicepre\u015fedinte al Agen\u0163iei Na\u0163ionale a Medicamentului. A fost membru al Comitetului pentru Medicamente de Uz Uman (CHMP) \u015fi al Comitetului Pediatric (PDCO) \u015fi membru altern (supleant) al Comitetului pentru Medicamente pe baz\u0103 de Plante din cadrul Agen\u0163iei Europene a Medicamentului (EMA), precum \u015fi membru \u00een mai multe comitete sau grupuri de lucru din domeniul farmaceutic. A publicat 56 articole \u015ftiin\u0163ifice indexate ISI, este autor a dou\u0103 c\u0103r\u0163i \u015fi co-autor la alte patru. Pe l\u00e2ng\u0103 interesul s\u0103u larg pentru toate aspectele domeniului farmaceutic, Robert se consider\u0103 un renascentist \u00eent\u00e2rziat, fiind interesat \u015fi de drept, istorie, muzic\u0103, biostatistic\u0103 \u0219i machine learning, sociologie \u015fi literatur\u0103.<\/span><\/p>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.9.6″ background_color=”rgba(117,194,33,0.23)” background_image=”https:\/\/pdi.ro\/2021\/wp-content\/uploads\/2021\/05\/PDI2021_header_1920x550px.jpg” background_blend=”multiply” custom_padding=”54px|0px|0|0px|false|false” top_divider_style=”waves2″ top_divider_color=”#ffffff” top_divider_height=”155px” top_divider_height_tablet=”” top_divider_height_phone=”97px” top_divider_height_last_edited=”on|desktop” bottom_divider_style=”waves2″ bottom_divider_color=”#75c221″ bottom_divider_flip=”vertical” bottom_divider_height_tablet=”” bottom_divider_height_phone=”59px” bottom_divider_height_last_edited=”on|desktop” saved_tabs=”all” global_module=”9177″][et_pb_row column_structure=”3_5,2_5″ _builder_version=”3.25″ custom_padding=”61px|0px|69px|0px|false|false”][et_pb_column type=”3_5″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.9.4″ text_font=”Kaushan Script||||||||” text_text_color=”#f0622a” text_font_size=”30px” text_line_height=”1.2em” header_font=”||||||||” background_layout=”dark” text_font_size_tablet=”” text_font_size_phone=”” text_font_size_last_edited=”on|desktop”]<\/p>\n
Contacteaz\u0103 operatorul PDI 2021<\/p>\n
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Operatorul PDI 2021<\/p>\n
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<\/span><\/p>\n<\/span><\/p>\n<\/span><\/p>\nAdresa: Str. A. Panu nr. 13, Iasi<\/span>
Tel.: 0332.40.88.00-05<\/span>
E-mail: inscrieri@primaderma.ro<\/a>
<\/span>Website:\u00a0<\/span>www.eventernet.ro<\/a><\/p>\n[\/et_pb_text][et_pb_text disabled_on=”off|off|off” _builder_version=”4.0.11″ text_font=”Kaushan Script||||||||” text_text_color=”#f0622a” text_font_size=”30px” header_font=”||||||||” background_layout=”dark” locked=”off”]<\/p>\n
Parteneri Media<\/p>\n
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Prof. Dr. Ancuceanu Robert U.M.F. “Carol Davila”, Bucure\u015ftiDezvoltarea de medicamente pentru epidermoliza buloas\u0103 Autori: R. Ancuceanu, Mihaela Dinu Cuvinte cheie: Epidermoliza buloas\u0103, medicamente orfane, studii clinice Obiective: Epidermoliza buloas\u0103 reprezint\u0103 un grup heterogen de afec\u0163iuni cutanate de natur\u0103 genetic\u0103, rare \u015fi nevindecabile, cauzate de muta\u0163ii ale unor gene codific\u00e2nd proteine structurale cheie din piele. Care […]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"class_list":["post-7459","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/pdi.ro\/2021\/wp-json\/wp\/v2\/pages\/7459","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdi.ro\/2021\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/pdi.ro\/2021\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/pdi.ro\/2021\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/pdi.ro\/2021\/wp-json\/wp\/v2\/comments?post=7459"}],"version-history":[{"count":8,"href":"https:\/\/pdi.ro\/2021\/wp-json\/wp\/v2\/pages\/7459\/revisions"}],"predecessor-version":[{"id":9572,"href":"https:\/\/pdi.ro\/2021\/wp-json\/wp\/v2\/pages\/7459\/revisions\/9572"}],"wp:attachment":[{"href":"https:\/\/pdi.ro\/2021\/wp-json\/wp\/v2\/media?parent=7459"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
Autori: R. Ancuceanu, Mihaela Dinu<\/span><\/p>\n
Cuvinte cheie: Epidermoliza buloas\u0103, medicamente orfane, studii clinice<\/span><\/p>\n Obiective: Epidermoliza buloas\u0103 reprezint\u0103 un grup heterogen de afec\u0163iuni cutanate de natur\u0103 genetic\u0103, rare \u015fi nevindecabile, cauzate de muta\u0163ii ale unor gene codific\u00e2nd proteine structurale cheie din piele. Care afec\u021biuni ar trebui incluse \u00een cadrul spectrului cunoscut generic drept \u201eepidermoliz\u0103 buloas\u0103\u201c \u0219i care nu, r\u0103m\u00e2ne o chestiune deschis\u0103. Cum aceste maladii sunt rare, ne-am propus identificarea medicamentelor desemnate ca orfane p\u00e2n\u0103 \u00een prezent \u0219i a provoc\u0103rilor pe care le prezint\u0103 dezvoltarea acestei categorii de medicamente.<\/span> \n Developing drugs for epidermolysis bullosa<\/span> Keywords: Epidermolysis bullosa, orphan medicines, clinical trials<\/span><\/p>\n Objectives: Epidermolysis bullosa is a heterogeneous group of skin disorders of genetic nature, rare and incurable, caused by mutations in genes encoding key structural proteins in the skin. Which conditions should be included within the spectrum known generically as “epidermolysis bullosa” and which should not, remains an open question. As these diseases are rare, we set out to identify which drugs have been designated as orphan drugs to date and the challenges of developing this category of drugs.<\/span> Scurt CV<\/span><\/p>\n Robert Ancuceanu este profesor \u015fi prodecan \u00een cadrul Facult\u0103\u0163ii de Farmacie din Bucure\u015fti, disciplina Botanic\u0103 farmaceutic\u0103 \u015fi biologie celular\u0103. Cu un doctorat \u00een farmacie, un masterat \u00een biostatistic\u0103 \u015fi licen\u0163\u0103 \u00een drept, a lucrat \u00een diferite domenii farmaceutice, de la cel academic la cel industrial \u015fi \u00een cadrul autorit\u0103\u0163ilor de reglementare. A fost director general al Direc\u0163iei Generale Farmaceutice \u015fi Aparatur\u0103 Medical\u0103 din Ministerul S\u0103n\u0103t\u0103\u0163ii \u015fi Vicepre\u015fedinte al Agen\u0163iei Na\u0163ionale a Medicamentului. A fost membru al Comitetului pentru Medicamente de Uz Uman (CHMP) \u015fi al Comitetului Pediatric (PDCO) \u015fi membru altern (supleant) al Comitetului pentru Medicamente pe baz\u0103 de Plante din cadrul Agen\u0163iei Europene a Medicamentului (EMA), precum \u015fi membru \u00een mai multe comitete sau grupuri de lucru din domeniul farmaceutic. A publicat 56 articole \u015ftiin\u0163ifice indexate ISI, este autor a dou\u0103 c\u0103r\u0163i \u015fi co-autor la alte patru. Pe l\u00e2ng\u0103 interesul s\u0103u larg pentru toate aspectele domeniului farmaceutic, Robert se consider\u0103 un renascentist \u00eent\u00e2rziat, fiind interesat \u015fi de drept, istorie, muzic\u0103, biostatistic\u0103 \u0219i machine learning, sociologie \u015fi literatur\u0103.<\/span><\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.9.6″ background_color=”rgba(117,194,33,0.23)” background_image=”https:\/\/pdi.ro\/2021\/wp-content\/uploads\/2021\/05\/PDI2021_header_1920x550px.jpg” background_blend=”multiply” custom_padding=”54px|0px|0|0px|false|false” top_divider_style=”waves2″ top_divider_color=”#ffffff” top_divider_height=”155px” top_divider_height_tablet=”” top_divider_height_phone=”97px” top_divider_height_last_edited=”on|desktop” bottom_divider_style=”waves2″ bottom_divider_color=”#75c221″ bottom_divider_flip=”vertical” bottom_divider_height_tablet=”” bottom_divider_height_phone=”59px” bottom_divider_height_last_edited=”on|desktop” saved_tabs=”all” global_module=”9177″][et_pb_row column_structure=”3_5,2_5″ _builder_version=”3.25″ custom_padding=”61px|0px|69px|0px|false|false”][et_pb_column type=”3_5″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.9.4″ text_font=”Kaushan Script||||||||” text_text_color=”#f0622a” text_font_size=”30px” text_line_height=”1.2em” header_font=”||||||||” background_layout=”dark” text_font_size_tablet=”” text_font_size_phone=”” text_font_size_last_edited=”on|desktop”]<\/p>\n Contacteaz\u0103 operatorul PDI 2021<\/p>\n [\/et_pb_text][et_pb_contact_form email=”contact@pdi.ro\/2021\/2019″ submit_button_text=”Trimite mesajul” _builder_version=”4.9.4″ title_font=”||||||||” custom_button=”on” button_text_color=”#F0622A”][et_pb_contact_field field_id=”Name” field_title=”Nume” _builder_version=”3.18.9″ button_text_size__hover_enabled=”off” button_one_text_size__hover_enabled=”off” 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_builder_version=”3.18.9″ button_text_size__hover_enabled=”off” button_one_text_size__hover_enabled=”off” button_two_text_size__hover_enabled=”off” button_text_color__hover_enabled=”off” button_one_text_color__hover_enabled=”off” button_two_text_color__hover_enabled=”off” button_border_width__hover_enabled=”off” button_one_border_width__hover_enabled=”off” button_two_border_width__hover_enabled=”off” button_border_color__hover_enabled=”off” button_one_border_color__hover_enabled=”off” button_two_border_color__hover_enabled=”off” button_border_radius__hover_enabled=”off” button_one_border_radius__hover_enabled=”off” button_two_border_radius__hover_enabled=”off” button_letter_spacing__hover_enabled=”off” button_one_letter_spacing__hover_enabled=”off” button_two_letter_spacing__hover_enabled=”off” button_bg_color__hover_enabled=”off” button_one_bg_color__hover_enabled=”off” button_two_bg_color__hover_enabled=”off”][\/et_pb_contact_field][\/et_pb_contact_form][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.9.4″ text_font=”Kaushan Script||||||||” text_text_color=”#f0622a” text_font_size=”30px” header_font=”||||||||” background_layout=”dark”]<\/p>\n Operatorul PDI 2021<\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.0.11″ text_font=”||||||||”]<\/p>\n <\/span><\/p>\n <\/span><\/p>\n Adresa: Str. A. Panu nr. 13, Iasi<\/span> [\/et_pb_text][et_pb_text disabled_on=”off|off|off” _builder_version=”4.0.11″ text_font=”Kaushan Script||||||||” text_text_color=”#f0622a” text_font_size=”30px” header_font=”||||||||” background_layout=”dark” locked=”off”]<\/p>\n Parteneri Media<\/p>\n [\/et_pb_text][et_pb_gallery gallery_ids=”7203,7204,9252,9464″ fullwidth=”on” _builder_version=”4.9.6″ transform_scale=”86%|86%” max_width=”63%” auto=”on” auto_speed=”3500″ hover_transition_duration=”100ms” hover_transition_delay=”50ms” hover_transition_speed_curve=”ease-in-out” locked=”off”][\/et_pb_gallery][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":" Prof. Dr. Ancuceanu Robert U.M.F. “Carol Davila”, Bucure\u015ftiDezvoltarea de medicamente pentru epidermoliza buloas\u0103 Autori: R. Ancuceanu, Mihaela Dinu Cuvinte cheie: Epidermoliza buloas\u0103, medicamente orfane, studii clinice Obiective: Epidermoliza buloas\u0103 reprezint\u0103 un grup heterogen de afec\u0163iuni cutanate de natur\u0103 genetic\u0103, rare \u015fi nevindecabile, cauzate de muta\u0163ii ale unor gene codific\u00e2nd proteine structurale cheie din piele. Care […]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"class_list":["post-7459","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/pdi.ro\/2021\/wp-json\/wp\/v2\/pages\/7459","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdi.ro\/2021\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/pdi.ro\/2021\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/pdi.ro\/2021\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/pdi.ro\/2021\/wp-json\/wp\/v2\/comments?post=7459"}],"version-history":[{"count":8,"href":"https:\/\/pdi.ro\/2021\/wp-json\/wp\/v2\/pages\/7459\/revisions"}],"predecessor-version":[{"id":9572,"href":"https:\/\/pdi.ro\/2021\/wp-json\/wp\/v2\/pages\/7459\/revisions\/9572"}],"wp:attachment":[{"href":"https:\/\/pdi.ro\/2021\/wp-json\/wp\/v2\/media?parent=7459"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
Materiale \u0219i metode: s-au examinat toate medicamentele \u00eenregistrate \u00een Registrul Uniunii Europene de medicamente orfane \u0219i \u00een web-site-ul FDA \u0219i s-au c\u0103utat informa\u021bii despre stadiul de dezvoltare clinic\u0103 al medicamentelor respective. De asemenea, printr-o interogare Medline s-au identificat studii clinice publicate p\u00e2n\u0103 \u00een prezent \u00een diverse forme de epidermoliz\u0103 buloas\u0103. Interog\u0103ri relevante au permis identificarea de studii clinice \u00een derulare sau ale c\u0103ror rezultate nu au fost \u00eenc\u0103 publicate.<\/span>
Rezultate: \u00cen Registrul Uniunii Europene de medicamente orfane s-au identificat un num\u0103r de 21 de intr\u0103ri (cel pu\u0163in dou\u0103 sunt duplicate), dintre care 20 se refer\u0103 la \u201etratamentul epidermoliezei buloase\u201c (f\u0103r\u0103 alte calificative sau identificatori), iar unul la tratamentul epidermolizei buloase distrofice. \u00cen SUA num\u0103rul medicamentelor orfane indicate pentru aceste grup de afec\u021biuni este ceva mai mare (25, dintre care cel pu\u021bin un duplicat \u0219i dou\u0103 retrase) \u0219i numai aproape jum\u0103tate sunt desemnate generic \u00een \u201eepidermoliza buloas\u0103\u201c.<\/span><\/p>\n
Autori: R. Ancuceanu, Mihaela Dinu<\/span><\/p>\n
Materials and methods: All drugs registered in the European Union Register of Orphan Medicinal Products and on the FDA website were reviewed and information on the clinical development status of these drugs was sought. A Medline search also identified clinical trials published to date in various forms of epidermolysis bullosa. Relevant queries identified ongoing clinical trials or trials whose results have not yet been published.<\/span>
Results: A total of 21 entries were identified in the European Union Register of Orphan Medicinal Products (at least two are duplicates), of which 20 refer to the “treatment of epidermolysis bullosa” (with no other qualifiers or identifiers) and one to the treatment of dystrophic epidermolysis bullosa. In the US the number of orphan drugs indicated for this group of conditions is somewhat higher (25, of which at least one duplicate and two withdrawn) and only about half are generically designated in “epidermolysis bullosa”.<\/span><\/p>\n<\/span><\/p>\n
Tel.: 0332.40.88.00-05<\/span>
E-mail: inscrieri@primaderma.ro<\/a>
<\/span>Website:\u00a0<\/span>www.eventernet.ro<\/a><\/p>\n