Integrating CMC document preparation into the development process for vaccine INDs
Vaccine process development is complex, and so are the documents required before clinical trials begin. Hagen et al discuss the need to minimize the preparation time required for the chemistry, manufacturing and controls section of an Investigational New Drug Application by integrating writing and d...
Gespeichert in:
| Veröffentlicht in: | Biopharm International 2003-09, Vol.16 (9), p.56 |
|---|---|
| Hauptverfasser: | , , , , , , , |
| Format: | Magazinearticle |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | |
|---|---|
| container_issue | 9 |
| container_start_page | 56 |
| container_title | Biopharm International |
| container_volume | 16 |
| creator | Hagen, Anna Aunins, Anne Howson, Laura Janus, Tracy LeGrow, Kathleen Robinett, Robin Thornton, Rachel Sitrin, Robert |
| description | Vaccine process development is complex, and so are the documents required before clinical trials begin. Hagen et al discuss the need to minimize the preparation time required for the chemistry, manufacturing and controls section of an Investigational New Drug Application by integrating writing and document preparation, and coordinating experienced technical writers and editors with other development activities. |
| format | Magazinearticle |
| fullrecord | <record><control><sourceid>gale_proqu</sourceid><recordid>TN_cdi_proquest_reports_195751587</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A108616572</galeid><sourcerecordid>A108616572</sourcerecordid><originalsourceid>FETCH-LOGICAL-g258t-5957d13de414d10eeb47eacd904ffc95cbfb9aa6607d7dd6bac31c43d2c22bbc3</originalsourceid><addsrcrecordid>eNptjs1OwzAQhCMEEqXwDuYBgmLHduJjFf4iFZAQSNwqZ70OQakdYrfPj1F7rPYwq91vRnOWLagqVU5ryc7TLjjLqZRfl9lVCD9FQetS8UX23rqI_azj4HrSvDTEeNht0UUyzTjp_4d3ZHDRk_iNxOAeRz8dAQ8YArF-JnsNMDgk7et9uM4urB4D3hx1mX0-Pnw0z_n67altVuu8Z6KOuVCiMrQ0yCk3tEDseIUajCq4taAEdLZTWktZVKYyRnYaSgq8NAwY6zool9ntITcV-d1hiJvU2M8xbGiKFlTUVWLyA9PrETeDsz7OGnp0OOvRO7RDOq9oUUsqRcUSf3eCT2NwO8AJwx-BLW08</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>magazinearticle</recordtype><pqid>195751587</pqid></control><display><type>magazinearticle</type><title>Integrating CMC document preparation into the development process for vaccine INDs</title><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><creator>Hagen, Anna ; Aunins, Anne ; Howson, Laura ; Janus, Tracy ; LeGrow, Kathleen ; Robinett, Robin ; Thornton, Rachel ; Sitrin, Robert</creator><creatorcontrib>Hagen, Anna ; Aunins, Anne ; Howson, Laura ; Janus, Tracy ; LeGrow, Kathleen ; Robinett, Robin ; Thornton, Rachel ; Sitrin, Robert</creatorcontrib><description>Vaccine process development is complex, and so are the documents required before clinical trials begin. Hagen et al discuss the need to minimize the preparation time required for the chemistry, manufacturing and controls section of an Investigational New Drug Application by integrating writing and document preparation, and coordinating experienced technical writers and editors with other development activities.</description><identifier>ISSN: 1542-166X</identifier><identifier>EISSN: 1939-1862</identifier><language>eng</language><publisher>Monmouth Junction: MJH Life Sciences Media</publisher><subject>Alliances ; Clinical trials ; Documentation ; Editors ; Manufacturing ; Pharmaceutical industry ; Pharmacology ; Product development ; Raw materials ; Regulatory agencies ; Technical communication ; Vaccines ; Writers</subject><ispartof>Biopharm International, 2003-09, Vol.16 (9), p.56</ispartof><rights>COPYRIGHT 2003 MJH Life Sciences Media</rights><rights>Copyright Advanstar Communications, Inc. Sep 2003</rights><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>312,776,780,787</link.rule.ids></links><search><creatorcontrib>Hagen, Anna</creatorcontrib><creatorcontrib>Aunins, Anne</creatorcontrib><creatorcontrib>Howson, Laura</creatorcontrib><creatorcontrib>Janus, Tracy</creatorcontrib><creatorcontrib>LeGrow, Kathleen</creatorcontrib><creatorcontrib>Robinett, Robin</creatorcontrib><creatorcontrib>Thornton, Rachel</creatorcontrib><creatorcontrib>Sitrin, Robert</creatorcontrib><title>Integrating CMC document preparation into the development process for vaccine INDs</title><title>Biopharm International</title><description>Vaccine process development is complex, and so are the documents required before clinical trials begin. Hagen et al discuss the need to minimize the preparation time required for the chemistry, manufacturing and controls section of an Investigational New Drug Application by integrating writing and document preparation, and coordinating experienced technical writers and editors with other development activities.</description><subject>Alliances</subject><subject>Clinical trials</subject><subject>Documentation</subject><subject>Editors</subject><subject>Manufacturing</subject><subject>Pharmaceutical industry</subject><subject>Pharmacology</subject><subject>Product development</subject><subject>Raw materials</subject><subject>Regulatory agencies</subject><subject>Technical communication</subject><subject>Vaccines</subject><subject>Writers</subject><issn>1542-166X</issn><issn>1939-1862</issn><fulltext>true</fulltext><rsrctype>magazinearticle</rsrctype><creationdate>2003</creationdate><recordtype>magazinearticle</recordtype><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNptjs1OwzAQhCMEEqXwDuYBgmLHduJjFf4iFZAQSNwqZ70OQakdYrfPj1F7rPYwq91vRnOWLagqVU5ryc7TLjjLqZRfl9lVCD9FQetS8UX23rqI_azj4HrSvDTEeNht0UUyzTjp_4d3ZHDRk_iNxOAeRz8dAQ8YArF-JnsNMDgk7et9uM4urB4D3hx1mX0-Pnw0z_n67altVuu8Z6KOuVCiMrQ0yCk3tEDseIUajCq4taAEdLZTWktZVKYyRnYaSgq8NAwY6zool9ntITcV-d1hiJvU2M8xbGiKFlTUVWLyA9PrETeDsz7OGnp0OOvRO7RDOq9oUUsqRcUSf3eCT2NwO8AJwx-BLW08</recordid><startdate>20030901</startdate><enddate>20030901</enddate><creator>Hagen, Anna</creator><creator>Aunins, Anne</creator><creator>Howson, Laura</creator><creator>Janus, Tracy</creator><creator>LeGrow, Kathleen</creator><creator>Robinett, Robin</creator><creator>Thornton, Rachel</creator><creator>Sitrin, Robert</creator><general>MJH Life Sciences Media</general><general>MultiMedia Healthcare Inc</general><scope>3V.</scope><scope>7RV</scope><scope>7WY</scope><scope>7XB</scope><scope>883</scope><scope>88I</scope><scope>8AF</scope><scope>8AO</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8FL</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BEZIV</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FRNLG</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HCIFZ</scope><scope>K60</scope><scope>K6~</scope><scope>KB0</scope><scope>L.-</scope><scope>LK8</scope><scope>M0F</scope><scope>M2O</scope><scope>M2P</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQBIZ</scope><scope>PQBZA</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope></search><sort><creationdate>20030901</creationdate><title>Integrating CMC document preparation into the development process for vaccine INDs</title><author>Hagen, Anna ; Aunins, Anne ; Howson, Laura ; Janus, Tracy ; LeGrow, Kathleen ; Robinett, Robin ; Thornton, Rachel ; Sitrin, Robert</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-g258t-5957d13de414d10eeb47eacd904ffc95cbfb9aa6607d7dd6bac31c43d2c22bbc3</frbrgroupid><rsrctype>magazinearticle</rsrctype><prefilter>magazinearticle</prefilter><language>eng</language><creationdate>2003</creationdate><topic>Alliances</topic><topic>Clinical trials</topic><topic>Documentation</topic><topic>Editors</topic><topic>Manufacturing</topic><topic>Pharmaceutical industry</topic><topic>Pharmacology</topic><topic>Product development</topic><topic>Raw materials</topic><topic>Regulatory agencies</topic><topic>Technical communication</topic><topic>Vaccines</topic><topic>Writers</topic><toplevel>online_resources</toplevel><creatorcontrib>Hagen, Anna</creatorcontrib><creatorcontrib>Aunins, Anne</creatorcontrib><creatorcontrib>Howson, Laura</creatorcontrib><creatorcontrib>Janus, Tracy</creatorcontrib><creatorcontrib>LeGrow, Kathleen</creatorcontrib><creatorcontrib>Robinett, Robin</creatorcontrib><creatorcontrib>Thornton, Rachel</creatorcontrib><creatorcontrib>Sitrin, Robert</creatorcontrib><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>ABI/INFORM Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>ABI/INFORM Trade & Industry (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>ProQuest Pharma Collection</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ABI/INFORM Collection (Alumni Edition)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Business Premium Collection</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Business Premium Collection (Alumni)</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Business Collection (Alumni Edition)</collection><collection>ProQuest Business Collection</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ABI/INFORM Professional Advanced</collection><collection>ProQuest Biological Science Collection</collection><collection>ABI/INFORM Trade & Industry</collection><collection>Research Library</collection><collection>Science Database</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Business</collection><collection>ProQuest One Business (Alumni)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><jtitle>Biopharm International</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hagen, Anna</au><au>Aunins, Anne</au><au>Howson, Laura</au><au>Janus, Tracy</au><au>LeGrow, Kathleen</au><au>Robinett, Robin</au><au>Thornton, Rachel</au><au>Sitrin, Robert</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Integrating CMC document preparation into the development process for vaccine INDs</atitle><jtitle>Biopharm International</jtitle><date>2003-09-01</date><risdate>2003</risdate><volume>16</volume><issue>9</issue><spage>56</spage><pages>56-</pages><issn>1542-166X</issn><eissn>1939-1862</eissn><abstract>Vaccine process development is complex, and so are the documents required before clinical trials begin. Hagen et al discuss the need to minimize the preparation time required for the chemistry, manufacturing and controls section of an Investigational New Drug Application by integrating writing and document preparation, and coordinating experienced technical writers and editors with other development activities.</abstract><cop>Monmouth Junction</cop><pub>MJH Life Sciences Media</pub></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1542-166X |
| ispartof | Biopharm International, 2003-09, Vol.16 (9), p.56 |
| issn | 1542-166X 1939-1862 |
| language | eng |
| recordid | cdi_proquest_reports_195751587 |
| source | Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals |
| subjects | Alliances Clinical trials Documentation Editors Manufacturing Pharmaceutical industry Pharmacology Product development Raw materials Regulatory agencies Technical communication Vaccines Writers |
| title | Integrating CMC document preparation into the development process for vaccine INDs |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-20T20%3A06%3A26IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_proqu&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Integrating%20CMC%20document%20preparation%20into%20the%20development%20process%20for%20vaccine%20INDs&rft.jtitle=Biopharm%20International&rft.au=Hagen,%20Anna&rft.date=2003-09-01&rft.volume=16&rft.issue=9&rft.spage=56&rft.pages=56-&rft.issn=1542-166X&rft.eissn=1939-1862&rft_id=info:doi/&rft_dat=%3Cgale_proqu%3EA108616572%3C/gale_proqu%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=195751587&rft_id=info:pmid/&rft_galeid=A108616572&rfr_iscdi=true |