More than 5 years of European Paediatric Regulation: Statistics and industrial experience
[Display omitted] The aim of the European paediatric legislation is to ensure high quality paediatric clinical research, and subsequently increase availability of authorised medicines that are appropriate for children and produce better information on medicines. One of the main pillars of the regula...
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| Veröffentlicht in: | International journal of pharmaceutics 2014-08, Vol.469 (2), p.260-262 |
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| container_title | International journal of pharmaceutics |
| container_volume | 469 |
| creator | Winzenburg, Gesine |
| description | [Display omitted]
The aim of the European paediatric legislation is to ensure high quality paediatric clinical research, and subsequently increase availability of authorised medicines that are appropriate for children and produce better information on medicines.
One of the main pillars of the regulation is the paediatric investigation plan (PIP), a new key document in the general drug development process. PIP submission and approval are now mandatory to ensure registration of a new drug in the EU.
A short summary of the achievements from the introduction of the regulation in 2007 is given. In addition, PIP case studies are presented to illustrate the challenges associated when working within the framework of the new process. |
| doi_str_mv | 10.1016/j.ijpharm.2014.03.058 |
| format | Article |
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The aim of the European paediatric legislation is to ensure high quality paediatric clinical research, and subsequently increase availability of authorised medicines that are appropriate for children and produce better information on medicines.
One of the main pillars of the regulation is the paediatric investigation plan (PIP), a new key document in the general drug development process. PIP submission and approval are now mandatory to ensure registration of a new drug in the EU.
A short summary of the achievements from the introduction of the regulation in 2007 is given. In addition, PIP case studies are presented to illustrate the challenges associated when working within the framework of the new process.</description><identifier>ISSN: 0378-5173</identifier><identifier>EISSN: 1873-3476</identifier><identifier>DOI: 10.1016/j.ijpharm.2014.03.058</identifier><identifier>PMID: 24704106</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>Child ; Dosage Forms ; Drug Industry - legislation & jurisprudence ; Drugs, Investigational ; European Union ; Humans ; Legislation, Drug ; Pediatrics - legislation & jurisprudence</subject><ispartof>International journal of pharmaceutics, 2014-08, Vol.469 (2), p.260-262</ispartof><rights>2014 Elsevier B.V.</rights><rights>Copyright © 2014 Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c398t-5942978c01b44c9998795aa7fb71ec59cfe096e4bfb1616e247ba63265dd851c3</citedby><cites>FETCH-LOGICAL-c398t-5942978c01b44c9998795aa7fb71ec59cfe096e4bfb1616e247ba63265dd851c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ijpharm.2014.03.058$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24704106$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Winzenburg, Gesine</creatorcontrib><title>More than 5 years of European Paediatric Regulation: Statistics and industrial experience</title><title>International journal of pharmaceutics</title><addtitle>Int J Pharm</addtitle><description>[Display omitted]
The aim of the European paediatric legislation is to ensure high quality paediatric clinical research, and subsequently increase availability of authorised medicines that are appropriate for children and produce better information on medicines.
One of the main pillars of the regulation is the paediatric investigation plan (PIP), a new key document in the general drug development process. PIP submission and approval are now mandatory to ensure registration of a new drug in the EU.
A short summary of the achievements from the introduction of the regulation in 2007 is given. In addition, PIP case studies are presented to illustrate the challenges associated when working within the framework of the new process.</description><subject>Child</subject><subject>Dosage Forms</subject><subject>Drug Industry - legislation & jurisprudence</subject><subject>Drugs, Investigational</subject><subject>European Union</subject><subject>Humans</subject><subject>Legislation, Drug</subject><subject>Pediatrics - legislation & jurisprudence</subject><issn>0378-5173</issn><issn>1873-3476</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkctOwzAQRS0EgvL4BJCXbBLsOLZjNghVvCQQiMeCleU4E3CVJsFOEP17XFrYsprR6NyZ0b0IHVKSUkLFySx1s_7d-HmaEZqnhKWEFxtoQgvJEpZLsYkmhMki4VSyHbQbwowQIjLKttFOlkuSUyIm6PWu84CHd9NijhdgfMBdjS9G3_UQZw8GKmcG7yx-hLexMYPr2lP8NMQmDM4GbNoKu7YaQ4RMg-GrB--gtbCPtmrTBDhY1z30cnnxPL1Obu-vbqbnt4llqhgSrvJMycISWua5VUoVUnFjZF1KCpYrWwNRAvKyLqmgAuLrpREsE7yqCk4t20PHq7297z5GCIOeu2ChaUwL3Rg0jVTGs0LS_1EejVMi0hHlK9T6LgQPte69mxu_0JToZQB6ptcB6GUAmjAdA4i6o_WJsZxD9af6dTwCZysAoiefDrwO9sevynmwg64698-Jb8FomSE</recordid><startdate>20140805</startdate><enddate>20140805</enddate><creator>Winzenburg, Gesine</creator><general>Elsevier B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>7U7</scope><scope>C1K</scope></search><sort><creationdate>20140805</creationdate><title>More than 5 years of European Paediatric Regulation: Statistics and industrial experience</title><author>Winzenburg, Gesine</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c398t-5942978c01b44c9998795aa7fb71ec59cfe096e4bfb1616e247ba63265dd851c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Child</topic><topic>Dosage Forms</topic><topic>Drug Industry - legislation & jurisprudence</topic><topic>Drugs, Investigational</topic><topic>European Union</topic><topic>Humans</topic><topic>Legislation, Drug</topic><topic>Pediatrics - legislation & jurisprudence</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Winzenburg, Gesine</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><jtitle>International journal of pharmaceutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Winzenburg, Gesine</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>More than 5 years of European Paediatric Regulation: Statistics and industrial experience</atitle><jtitle>International journal of pharmaceutics</jtitle><addtitle>Int J Pharm</addtitle><date>2014-08-05</date><risdate>2014</risdate><volume>469</volume><issue>2</issue><spage>260</spage><epage>262</epage><pages>260-262</pages><issn>0378-5173</issn><eissn>1873-3476</eissn><abstract>[Display omitted]
The aim of the European paediatric legislation is to ensure high quality paediatric clinical research, and subsequently increase availability of authorised medicines that are appropriate for children and produce better information on medicines.
One of the main pillars of the regulation is the paediatric investigation plan (PIP), a new key document in the general drug development process. PIP submission and approval are now mandatory to ensure registration of a new drug in the EU.
A short summary of the achievements from the introduction of the regulation in 2007 is given. In addition, PIP case studies are presented to illustrate the challenges associated when working within the framework of the new process.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>24704106</pmid><doi>10.1016/j.ijpharm.2014.03.058</doi><tpages>3</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0378-5173 |
| ispartof | International journal of pharmaceutics, 2014-08, Vol.469 (2), p.260-262 |
| issn | 0378-5173 1873-3476 |
| language | eng |
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| source | MEDLINE; Access via ScienceDirect (Elsevier) |
| subjects | Child Dosage Forms Drug Industry - legislation & jurisprudence Drugs, Investigational European Union Humans Legislation, Drug Pediatrics - legislation & jurisprudence |
| title | More than 5 years of European Paediatric Regulation: Statistics and industrial experience |
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