Extractables & Leachables :: [E & L 2012 conference proceedings] : delivering pharmaceuticals safely : 12-13 December 2012, Vienna, Austria /
These proceedings cover all the presentations from this conference which featured a comprehensive representation of best practice examples in pharmaceutical packaging, as well as the latest regulatory and working group updates, analytical chemist perspectives, and technical innovations from top phar...
Gespeichert in:
| Körperschaften: | , |
|---|---|
| Format: | Elektronisch Tagungsbericht E-Book |
| Sprache: | English |
| Veröffentlicht: |
Vienna, Austria :
Smithers Information Ltd.,
2012.
|
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Zusammenfassung: | These proceedings cover all the presentations from this conference which featured a comprehensive representation of best practice examples in pharmaceutical packaging, as well as the latest regulatory and working group updates, analytical chemist perspectives, and technical innovations from top pharmaceutical companies and materials suppliers. |
| Beschreibung: | "Extractables & leachables Europe 2012"--Cover |
| Beschreibung: | 1 online resource (142 pages) : illustrations, portraits |
| Bibliographie: | Includes bibliographical references. |
| ISBN: | 9781909030350 190903035X |
Internformat
MARC
| LEADER | 00000cam a2200000 i 4500 | ||
|---|---|---|---|
| 001 | ZDB-4-EBA-ocn868971914 | ||
| 003 | OCoLC | ||
| 005 | 20241004212047.0 | ||
| 006 | m o d | ||
| 007 | cr cn||||||||| | ||
| 008 | 131108s2012 au acd ob 100 0 eng d | ||
| 040 | |a E7B |b eng |e rda |e pn |c E7B |d OCLCO |d N$T |d OCLCO |d OCLCF |d YDXCP |d EBLCP |d OCLCO |d OCL |d OCLCO |d OCLCQ |d OCLCO |d COCUF |d MOR |d CCO |d PIFAG |d ZCU |d MERUC |d OCLCQ |d IGB |d AGLDB |d U3W |d D6H |d CN8ML |d STF |d VNS |d OCLCQ |d CUY |d VTS |d OCLCA |d OCLCQ |d S9I |d M8D |d OCLCQ |d AJS |d OCLCO |d OCLCQ |d OCLCO | ||
| 019 | |a 861559311 |a 907212282 |a 961590685 |a 962697951 | ||
| 020 | |a 9781909030350 |q (electronic bk.) | ||
| 020 | |a 190903035X |q (electronic bk.) | ||
| 020 | |z 9781909030343 | ||
| 035 | |a (OCoLC)868971914 |z (OCoLC)861559311 |z (OCoLC)907212282 |z (OCoLC)961590685 |z (OCoLC)962697951 | ||
| 050 | 4 | |a HD9665.1 |b .E98 2012eb | |
| 072 | 7 | |a PHI |x 026000 |2 bisacsh | |
| 072 | 7 | |a PHI |x 040000 |2 bisacsh | |
| 072 | 7 | |a PHI |x 006000 |2 bisacsh | |
| 082 | 7 | |a 142 | |
| 049 | |a MAIN | ||
| 111 | 2 | |a Extractables & Leachables for Pharmaceutical Products |d (2012 : |c Europe), |j issuing body. | |
| 245 | 1 | 0 | |a Extractables & Leachables : |b [E & L 2012 conference proceedings] : delivering pharmaceuticals safely : 12-13 December 2012, Vienna, Austria / |c organised by Smithers Rapra. |
| 246 | 3 | |a Extractables and Leachables : |b [E and L 2012 conference proceedings] | |
| 264 | 1 | |a Vienna, Austria : |b Smithers Information Ltd., |c 2012. | |
| 300 | |a 1 online resource (142 pages) : |b illustrations, portraits | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 347 | |a data file | ||
| 500 | |a "Extractables & leachables Europe 2012"--Cover | ||
| 504 | |a Includes bibliographical references. | ||
| 588 | 0 | |a Online resource; title from PDF title page (ebrary, viewed November 8, 2013). | |
| 505 | 0 | |a 9781909030343_FrontCover; Contents; Paper 1 Introduction to extractables and leachables; Paper 2 European regulatory perspective on extractables and leachables; Paper 3 ELSIE Controlled Extraction Studies Pilot Program for plastic materials: achievements, recommendations and future perspectives; Paper 4 PQRI extractable and leachables in parenteral and ophthalmic drug products (PODP): An evolving strategy; Paper 5 The problematic and concrete cases concerning large volume parenteral drugs. | |
| 505 | 8 | |a Paper 6 Understanding the safety qualification process by determining various safety thresholds for leachablesPaper 7 A risk based approach to qualify process aids with respect to E & L's; Paper 8 Procedures for determining acceptable daily exposure (ADE) for leachables into drug products; Paper 9 Toxicological evaluation of E & Ls: in silico and read across, with specific reference to genotoxicity and current guidelines and practice; Paper 10 Extractables and leachables in topical products during development; Paper 11 Extractables & Leachables in the life cycle of dialysis solutions. | |
| 505 | 8 | |a Paper 12 Analysis of drug-packaging interactions via molecular dynamics (MD) simulationsPaper 13 The use of chemometric analysis in the validation of FTIR extractable methods, used as an alternative to chromatographic analysis, as part of a control strategy for plastic extractables; Paper 14 Investigation of inorganic extractables in elastomeric materials for pharmaceutical applications; Paper 15 (Halo)Butyl oligomers in pharmaceutical rubbers; Paper 16 The leachables simulation process; strategies for study design and development and case studies; 9781909030343_BackCover. | |
| 520 | |a These proceedings cover all the presentations from this conference which featured a comprehensive representation of best practice examples in pharmaceutical packaging, as well as the latest regulatory and working group updates, analytical chemist perspectives, and technical innovations from top pharmaceutical companies and materials suppliers. | ||
| 650 | 0 | |a Drugs |v Congresses. | |
| 650 | 0 | |a Pharmaceutical industry |v Congresses. | |
| 650 | 6 | |a Médicaments |v Congrès. | |
| 650 | 6 | |a Industrie pharmaceutique |v Congrès. | |
| 650 | 7 | |a PHILOSOPHY |x Criticism. |2 bisacsh | |
| 650 | 7 | |a PHILOSOPHY |x Movements |x Critical Theory. |2 bisacsh | |
| 650 | 7 | |a PHILOSOPHY |x Movements |x Existentialism. |2 bisacsh | |
| 650 | 7 | |a Drugs |2 fast | |
| 650 | 7 | |a Pharmaceutical industry |2 fast | |
| 655 | 7 | |a Conference papers and proceedings |2 fast | |
| 710 | 2 | |a Smithers Rapra. | |
| 776 | 0 | 8 | |i Print version: |a Rapra, Smithers. |t Extractables and Leachables Europe 2012. |d Shrewsbury : iSmithers Rapra Publishing, ©2013 |z 9781909030343 |
| 856 | 4 | 0 | |l FWS01 |p ZDB-4-EBA |q FWS_PDA_EBA |u https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=653182 |3 Volltext |
| 936 | |a BATCHLOAD | ||
| 938 | |a ProQuest Ebook Central |b EBLB |n EBL1481091 | ||
| 938 | |a ebrary |b EBRY |n ebr10785175 | ||
| 938 | |a EBSCOhost |b EBSC |n 653182 | ||
| 938 | |a YBP Library Services |b YANK |n 11254664 | ||
| 994 | |a 92 |b GEBAY | ||
| 912 | |a ZDB-4-EBA | ||
| 049 | |a DE-863 | ||
Datensatz im Suchindex
| DE-BY-FWS_katkey | ZDB-4-EBA-ocn868971914 |
|---|---|
| _version_ | 1816882258624118784 |
| adam_text | |
| any_adam_object | |
| author_corporate | Extractables & Leachables for Pharmaceutical Products Europe Smithers Rapra |
| author_corporate_role | |
| author_facet | Extractables & Leachables for Pharmaceutical Products Europe Smithers Rapra |
| author_sort | Extractables & Leachables for Pharmaceutical Products Europe |
| building | Verbundindex |
| bvnumber | localFWS |
| callnumber-first | H - Social Science |
| callnumber-label | HD9665 |
| callnumber-raw | HD9665.1 .E98 2012eb |
| callnumber-search | HD9665.1 .E98 2012eb |
| callnumber-sort | HD 49665.1 E98 42012EB |
| callnumber-subject | HD - Industries, Land Use, Labor |
| collection | ZDB-4-EBA |
| contents | 9781909030343_FrontCover; Contents; Paper 1 Introduction to extractables and leachables; Paper 2 European regulatory perspective on extractables and leachables; Paper 3 ELSIE Controlled Extraction Studies Pilot Program for plastic materials: achievements, recommendations and future perspectives; Paper 4 PQRI extractable and leachables in parenteral and ophthalmic drug products (PODP): An evolving strategy; Paper 5 The problematic and concrete cases concerning large volume parenteral drugs. Paper 6 Understanding the safety qualification process by determining various safety thresholds for leachablesPaper 7 A risk based approach to qualify process aids with respect to E & L's; Paper 8 Procedures for determining acceptable daily exposure (ADE) for leachables into drug products; Paper 9 Toxicological evaluation of E & Ls: in silico and read across, with specific reference to genotoxicity and current guidelines and practice; Paper 10 Extractables and leachables in topical products during development; Paper 11 Extractables & Leachables in the life cycle of dialysis solutions. Paper 12 Analysis of drug-packaging interactions via molecular dynamics (MD) simulationsPaper 13 The use of chemometric analysis in the validation of FTIR extractable methods, used as an alternative to chromatographic analysis, as part of a control strategy for plastic extractables; Paper 14 Investigation of inorganic extractables in elastomeric materials for pharmaceutical applications; Paper 15 (Halo)Butyl oligomers in pharmaceutical rubbers; Paper 16 The leachables simulation process; strategies for study design and development and case studies; 9781909030343_BackCover. |
| ctrlnum | (OCoLC)868971914 |
| dewey-full | 142 |
| dewey-hundreds | 100 - Philosophy & psychology |
| dewey-ones | 142 - Critical philosophy |
| dewey-raw | 142 |
| dewey-search | 142 |
| dewey-sort | 3142 |
| dewey-tens | 140 - Specific philosophical schools |
| discipline | Philosophie |
| format | Electronic Conference Proceeding eBook |
| fullrecord | <?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>04930cam a2200661 i 4500</leader><controlfield tag="001">ZDB-4-EBA-ocn868971914</controlfield><controlfield tag="003">OCoLC</controlfield><controlfield tag="005">20241004212047.0</controlfield><controlfield tag="006">m o d </controlfield><controlfield tag="007">cr cn|||||||||</controlfield><controlfield tag="008">131108s2012 au acd ob 100 0 eng d</controlfield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">E7B</subfield><subfield code="b">eng</subfield><subfield code="e">rda</subfield><subfield code="e">pn</subfield><subfield code="c">E7B</subfield><subfield code="d">OCLCO</subfield><subfield code="d">N$T</subfield><subfield code="d">OCLCO</subfield><subfield code="d">OCLCF</subfield><subfield code="d">YDXCP</subfield><subfield code="d">EBLCP</subfield><subfield code="d">OCLCO</subfield><subfield code="d">OCL</subfield><subfield code="d">OCLCO</subfield><subfield code="d">OCLCQ</subfield><subfield code="d">OCLCO</subfield><subfield code="d">COCUF</subfield><subfield code="d">MOR</subfield><subfield code="d">CCO</subfield><subfield code="d">PIFAG</subfield><subfield code="d">ZCU</subfield><subfield code="d">MERUC</subfield><subfield code="d">OCLCQ</subfield><subfield code="d">IGB</subfield><subfield code="d">AGLDB</subfield><subfield code="d">U3W</subfield><subfield code="d">D6H</subfield><subfield code="d">CN8ML</subfield><subfield code="d">STF</subfield><subfield code="d">VNS</subfield><subfield code="d">OCLCQ</subfield><subfield code="d">CUY</subfield><subfield code="d">VTS</subfield><subfield code="d">OCLCA</subfield><subfield code="d">OCLCQ</subfield><subfield code="d">S9I</subfield><subfield code="d">M8D</subfield><subfield code="d">OCLCQ</subfield><subfield code="d">AJS</subfield><subfield code="d">OCLCO</subfield><subfield code="d">OCLCQ</subfield><subfield code="d">OCLCO</subfield></datafield><datafield tag="019" ind1=" " ind2=" "><subfield code="a">861559311</subfield><subfield code="a">907212282</subfield><subfield code="a">961590685</subfield><subfield code="a">962697951</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">9781909030350</subfield><subfield code="q">(electronic bk.)</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">190903035X</subfield><subfield code="q">(electronic bk.)</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="z">9781909030343</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(OCoLC)868971914</subfield><subfield code="z">(OCoLC)861559311</subfield><subfield code="z">(OCoLC)907212282</subfield><subfield code="z">(OCoLC)961590685</subfield><subfield code="z">(OCoLC)962697951</subfield></datafield><datafield tag="050" ind1=" " ind2="4"><subfield code="a">HD9665.1</subfield><subfield code="b">.E98 2012eb</subfield></datafield><datafield tag="072" ind1=" " ind2="7"><subfield code="a">PHI</subfield><subfield code="x">026000</subfield><subfield code="2">bisacsh</subfield></datafield><datafield tag="072" ind1=" " ind2="7"><subfield code="a">PHI</subfield><subfield code="x">040000</subfield><subfield code="2">bisacsh</subfield></datafield><datafield tag="072" ind1=" " ind2="7"><subfield code="a">PHI</subfield><subfield code="x">006000</subfield><subfield code="2">bisacsh</subfield></datafield><datafield tag="082" ind1="7" ind2=" "><subfield code="a">142</subfield></datafield><datafield tag="049" ind1=" " ind2=" "><subfield code="a">MAIN</subfield></datafield><datafield tag="111" ind1="2" ind2=" "><subfield code="a">Extractables & Leachables for Pharmaceutical Products</subfield><subfield code="d">(2012 :</subfield><subfield code="c">Europe),</subfield><subfield code="j">issuing body.</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Extractables & Leachables :</subfield><subfield code="b">[E & L 2012 conference proceedings] : delivering pharmaceuticals safely : 12-13 December 2012, Vienna, Austria /</subfield><subfield code="c">organised by Smithers Rapra.</subfield></datafield><datafield tag="246" ind1="3" ind2=" "><subfield code="a">Extractables and Leachables :</subfield><subfield code="b">[E and L 2012 conference proceedings]</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="a">Vienna, Austria :</subfield><subfield code="b">Smithers Information Ltd.,</subfield><subfield code="c">2012.</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="a">1 online resource (142 pages) :</subfield><subfield code="b">illustrations, portraits</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">computer</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">online resource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="347" ind1=" " ind2=" "><subfield code="a">data file</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">"Extractables & leachables Europe 2012"--Cover</subfield></datafield><datafield tag="504" ind1=" " ind2=" "><subfield code="a">Includes bibliographical references.</subfield></datafield><datafield tag="588" ind1="0" ind2=" "><subfield code="a">Online resource; title from PDF title page (ebrary, viewed November 8, 2013).</subfield></datafield><datafield tag="505" ind1="0" ind2=" "><subfield code="a">9781909030343_FrontCover; Contents; Paper 1 Introduction to extractables and leachables; Paper 2 European regulatory perspective on extractables and leachables; Paper 3 ELSIE Controlled Extraction Studies Pilot Program for plastic materials: achievements, recommendations and future perspectives; Paper 4 PQRI extractable and leachables in parenteral and ophthalmic drug products (PODP): An evolving strategy; Paper 5 The problematic and concrete cases concerning large volume parenteral drugs.</subfield></datafield><datafield tag="505" ind1="8" ind2=" "><subfield code="a">Paper 6 Understanding the safety qualification process by determining various safety thresholds for leachablesPaper 7 A risk based approach to qualify process aids with respect to E & L's; Paper 8 Procedures for determining acceptable daily exposure (ADE) for leachables into drug products; Paper 9 Toxicological evaluation of E & Ls: in silico and read across, with specific reference to genotoxicity and current guidelines and practice; Paper 10 Extractables and leachables in topical products during development; Paper 11 Extractables & Leachables in the life cycle of dialysis solutions.</subfield></datafield><datafield tag="505" ind1="8" ind2=" "><subfield code="a">Paper 12 Analysis of drug-packaging interactions via molecular dynamics (MD) simulationsPaper 13 The use of chemometric analysis in the validation of FTIR extractable methods, used as an alternative to chromatographic analysis, as part of a control strategy for plastic extractables; Paper 14 Investigation of inorganic extractables in elastomeric materials for pharmaceutical applications; Paper 15 (Halo)Butyl oligomers in pharmaceutical rubbers; Paper 16 The leachables simulation process; strategies for study design and development and case studies; 9781909030343_BackCover.</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">These proceedings cover all the presentations from this conference which featured a comprehensive representation of best practice examples in pharmaceutical packaging, as well as the latest regulatory and working group updates, analytical chemist perspectives, and technical innovations from top pharmaceutical companies and materials suppliers.</subfield></datafield><datafield tag="650" ind1=" " ind2="0"><subfield code="a">Drugs</subfield><subfield code="v">Congresses.</subfield></datafield><datafield tag="650" ind1=" " ind2="0"><subfield code="a">Pharmaceutical industry</subfield><subfield code="v">Congresses.</subfield></datafield><datafield tag="650" ind1=" " ind2="6"><subfield code="a">Médicaments</subfield><subfield code="v">Congrès.</subfield></datafield><datafield tag="650" ind1=" " ind2="6"><subfield code="a">Industrie pharmaceutique</subfield><subfield code="v">Congrès.</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">PHILOSOPHY</subfield><subfield code="x">Criticism.</subfield><subfield code="2">bisacsh</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">PHILOSOPHY</subfield><subfield code="x">Movements</subfield><subfield code="x">Critical Theory.</subfield><subfield code="2">bisacsh</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">PHILOSOPHY</subfield><subfield code="x">Movements</subfield><subfield code="x">Existentialism.</subfield><subfield code="2">bisacsh</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Drugs</subfield><subfield code="2">fast</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Pharmaceutical industry</subfield><subfield code="2">fast</subfield></datafield><datafield tag="655" ind1=" " ind2="7"><subfield code="a">Conference papers and proceedings</subfield><subfield code="2">fast</subfield></datafield><datafield tag="710" ind1="2" ind2=" "><subfield code="a">Smithers Rapra.</subfield></datafield><datafield tag="776" ind1="0" ind2="8"><subfield code="i">Print version:</subfield><subfield code="a">Rapra, Smithers.</subfield><subfield code="t">Extractables and Leachables Europe 2012.</subfield><subfield code="d">Shrewsbury : iSmithers Rapra Publishing, ©2013</subfield><subfield code="z">9781909030343</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="l">FWS01</subfield><subfield code="p">ZDB-4-EBA</subfield><subfield code="q">FWS_PDA_EBA</subfield><subfield code="u">https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=653182</subfield><subfield code="3">Volltext</subfield></datafield><datafield tag="936" ind1=" " ind2=" "><subfield code="a">BATCHLOAD</subfield></datafield><datafield tag="938" ind1=" " ind2=" "><subfield code="a">ProQuest Ebook Central</subfield><subfield code="b">EBLB</subfield><subfield code="n">EBL1481091</subfield></datafield><datafield tag="938" ind1=" " ind2=" "><subfield code="a">ebrary</subfield><subfield code="b">EBRY</subfield><subfield code="n">ebr10785175</subfield></datafield><datafield tag="938" ind1=" " ind2=" "><subfield code="a">EBSCOhost</subfield><subfield code="b">EBSC</subfield><subfield code="n">653182</subfield></datafield><datafield tag="938" ind1=" " ind2=" "><subfield code="a">YBP Library Services</subfield><subfield code="b">YANK</subfield><subfield code="n">11254664</subfield></datafield><datafield tag="994" ind1=" " ind2=" "><subfield code="a">92</subfield><subfield code="b">GEBAY</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">ZDB-4-EBA</subfield></datafield><datafield tag="049" ind1=" " ind2=" "><subfield code="a">DE-863</subfield></datafield></record></collection> |
| genre | Conference papers and proceedings fast |
| genre_facet | Conference papers and proceedings |
| id | ZDB-4-EBA-ocn868971914 |
| illustrated | Illustrated |
| indexdate | 2024-11-27T13:25:45Z |
| institution | BVB |
| isbn | 9781909030350 190903035X |
| language | English |
| oclc_num | 868971914 |
| open_access_boolean | |
| owner | MAIN DE-863 DE-BY-FWS |
| owner_facet | MAIN DE-863 DE-BY-FWS |
| physical | 1 online resource (142 pages) : illustrations, portraits |
| psigel | ZDB-4-EBA |
| publishDate | 2012 |
| publishDateSearch | 2012 |
| publishDateSort | 2012 |
| publisher | Smithers Information Ltd., |
| record_format | marc |
| spelling | Extractables & Leachables for Pharmaceutical Products (2012 : Europe), issuing body. Extractables & Leachables : [E & L 2012 conference proceedings] : delivering pharmaceuticals safely : 12-13 December 2012, Vienna, Austria / organised by Smithers Rapra. Extractables and Leachables : [E and L 2012 conference proceedings] Vienna, Austria : Smithers Information Ltd., 2012. 1 online resource (142 pages) : illustrations, portraits text txt rdacontent computer c rdamedia online resource cr rdacarrier data file "Extractables & leachables Europe 2012"--Cover Includes bibliographical references. Online resource; title from PDF title page (ebrary, viewed November 8, 2013). 9781909030343_FrontCover; Contents; Paper 1 Introduction to extractables and leachables; Paper 2 European regulatory perspective on extractables and leachables; Paper 3 ELSIE Controlled Extraction Studies Pilot Program for plastic materials: achievements, recommendations and future perspectives; Paper 4 PQRI extractable and leachables in parenteral and ophthalmic drug products (PODP): An evolving strategy; Paper 5 The problematic and concrete cases concerning large volume parenteral drugs. Paper 6 Understanding the safety qualification process by determining various safety thresholds for leachablesPaper 7 A risk based approach to qualify process aids with respect to E & L's; Paper 8 Procedures for determining acceptable daily exposure (ADE) for leachables into drug products; Paper 9 Toxicological evaluation of E & Ls: in silico and read across, with specific reference to genotoxicity and current guidelines and practice; Paper 10 Extractables and leachables in topical products during development; Paper 11 Extractables & Leachables in the life cycle of dialysis solutions. Paper 12 Analysis of drug-packaging interactions via molecular dynamics (MD) simulationsPaper 13 The use of chemometric analysis in the validation of FTIR extractable methods, used as an alternative to chromatographic analysis, as part of a control strategy for plastic extractables; Paper 14 Investigation of inorganic extractables in elastomeric materials for pharmaceutical applications; Paper 15 (Halo)Butyl oligomers in pharmaceutical rubbers; Paper 16 The leachables simulation process; strategies for study design and development and case studies; 9781909030343_BackCover. These proceedings cover all the presentations from this conference which featured a comprehensive representation of best practice examples in pharmaceutical packaging, as well as the latest regulatory and working group updates, analytical chemist perspectives, and technical innovations from top pharmaceutical companies and materials suppliers. Drugs Congresses. Pharmaceutical industry Congresses. Médicaments Congrès. Industrie pharmaceutique Congrès. PHILOSOPHY Criticism. bisacsh PHILOSOPHY Movements Critical Theory. bisacsh PHILOSOPHY Movements Existentialism. bisacsh Drugs fast Pharmaceutical industry fast Conference papers and proceedings fast Smithers Rapra. Print version: Rapra, Smithers. Extractables and Leachables Europe 2012. Shrewsbury : iSmithers Rapra Publishing, ©2013 9781909030343 FWS01 ZDB-4-EBA FWS_PDA_EBA https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=653182 Volltext |
| spellingShingle | Extractables & Leachables : [E & L 2012 conference proceedings] : delivering pharmaceuticals safely : 12-13 December 2012, Vienna, Austria / 9781909030343_FrontCover; Contents; Paper 1 Introduction to extractables and leachables; Paper 2 European regulatory perspective on extractables and leachables; Paper 3 ELSIE Controlled Extraction Studies Pilot Program for plastic materials: achievements, recommendations and future perspectives; Paper 4 PQRI extractable and leachables in parenteral and ophthalmic drug products (PODP): An evolving strategy; Paper 5 The problematic and concrete cases concerning large volume parenteral drugs. Paper 6 Understanding the safety qualification process by determining various safety thresholds for leachablesPaper 7 A risk based approach to qualify process aids with respect to E & L's; Paper 8 Procedures for determining acceptable daily exposure (ADE) for leachables into drug products; Paper 9 Toxicological evaluation of E & Ls: in silico and read across, with specific reference to genotoxicity and current guidelines and practice; Paper 10 Extractables and leachables in topical products during development; Paper 11 Extractables & Leachables in the life cycle of dialysis solutions. Paper 12 Analysis of drug-packaging interactions via molecular dynamics (MD) simulationsPaper 13 The use of chemometric analysis in the validation of FTIR extractable methods, used as an alternative to chromatographic analysis, as part of a control strategy for plastic extractables; Paper 14 Investigation of inorganic extractables in elastomeric materials for pharmaceutical applications; Paper 15 (Halo)Butyl oligomers in pharmaceutical rubbers; Paper 16 The leachables simulation process; strategies for study design and development and case studies; 9781909030343_BackCover. Drugs Congresses. Pharmaceutical industry Congresses. Médicaments Congrès. Industrie pharmaceutique Congrès. PHILOSOPHY Criticism. bisacsh PHILOSOPHY Movements Critical Theory. bisacsh PHILOSOPHY Movements Existentialism. bisacsh Drugs fast Pharmaceutical industry fast |
| title | Extractables & Leachables : [E & L 2012 conference proceedings] : delivering pharmaceuticals safely : 12-13 December 2012, Vienna, Austria / |
| title_alt | Extractables and Leachables : [E and L 2012 conference proceedings] |
| title_auth | Extractables & Leachables : [E & L 2012 conference proceedings] : delivering pharmaceuticals safely : 12-13 December 2012, Vienna, Austria / |
| title_exact_search | Extractables & Leachables : [E & L 2012 conference proceedings] : delivering pharmaceuticals safely : 12-13 December 2012, Vienna, Austria / |
| title_full | Extractables & Leachables : [E & L 2012 conference proceedings] : delivering pharmaceuticals safely : 12-13 December 2012, Vienna, Austria / organised by Smithers Rapra. |
| title_fullStr | Extractables & Leachables : [E & L 2012 conference proceedings] : delivering pharmaceuticals safely : 12-13 December 2012, Vienna, Austria / organised by Smithers Rapra. |
| title_full_unstemmed | Extractables & Leachables : [E & L 2012 conference proceedings] : delivering pharmaceuticals safely : 12-13 December 2012, Vienna, Austria / organised by Smithers Rapra. |
| title_short | Extractables & Leachables : |
| title_sort | extractables leachables e l 2012 conference proceedings delivering pharmaceuticals safely 12 13 december 2012 vienna austria |
| title_sub | [E & L 2012 conference proceedings] : delivering pharmaceuticals safely : 12-13 December 2012, Vienna, Austria / |
| topic | Drugs Congresses. Pharmaceutical industry Congresses. Médicaments Congrès. Industrie pharmaceutique Congrès. PHILOSOPHY Criticism. bisacsh PHILOSOPHY Movements Critical Theory. bisacsh PHILOSOPHY Movements Existentialism. bisacsh Drugs fast Pharmaceutical industry fast |
| topic_facet | Drugs Congresses. Pharmaceutical industry Congresses. Médicaments Congrès. Industrie pharmaceutique Congrès. PHILOSOPHY Criticism. PHILOSOPHY Movements Critical Theory. PHILOSOPHY Movements Existentialism. Drugs Pharmaceutical industry Conference papers and proceedings |
| url | https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=653182 |
| work_keys_str_mv | AT extractablesleachablesforpharmaceuticalproductseurope extractablesleachablesel2012conferenceproceedingsdeliveringpharmaceuticalssafely1213december2012viennaaustria AT smithersrapra extractablesleachablesel2012conferenceproceedingsdeliveringpharmaceuticalssafely1213december2012viennaaustria AT extractablesleachablesforpharmaceuticalproductseurope extractablesandleachableseandl2012conferenceproceedings AT smithersrapra extractablesandleachableseandl2012conferenceproceedings |