ICH quality guidelines: an implementation guide
"Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. Addresses a consistent need for interpr...
Gespeichert in:
| Weitere Verfasser: | , , |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Hoboken, NJ
Wiley
2018
|
| Ausgabe: | First edition |
| Schlagworte: | |
| Online-Zugang: | FRO01 UBG01 UER01 URL des Erstveröffentlichers |
| Zusammenfassung: | "Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies. Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines. Uses case studies to help readers understand and apply ICH guidelines. Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines. Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)"-- |
| Beschreibung: | 1 Online-Ressource |
| ISBN: | 9781118971147 9781118971123 |
Internformat
MARC
| LEADER | 00000nmm a2200000zc 4500 | ||
|---|---|---|---|
| 001 | BV044654140 | ||
| 003 | DE-604 | ||
| 005 | 20240416 | ||
| 007 | cr|uuu---uuuuu | ||
| 008 | 171128s2018 |||| o||u| ||||||eng d | ||
| 020 | |a 9781118971147 |c Online |9 9781118971147 | ||
| 020 | |a 9781118971123 |c Online, ePDF |9 9781118971123 | ||
| 024 | 7 | |a 10.1002/9781118971147 |2 doi | |
| 035 | |a (OCoLC)1013522330 | ||
| 035 | |a (DE-599)BVBBV044654140 | ||
| 040 | |a DE-604 |b ger |e rda | ||
| 041 | 0 | |a eng | |
| 049 | |a DE-861 |a DE-29 | ||
| 082 | 0 | |a 615.1/9 | |
| 084 | |a VX 5500 |0 (DE-625)147800:253 |2 rvk | ||
| 245 | 1 | 0 | |a ICH quality guidelines |b an implementation guide |c edited by Andrew Teasdale (AstraZeneca, London, UK), David Elder (Consultant (former GSK), Hertford, Hertfordshire, UK), Raymond W. Nims (RMC Pharmaceutical Solutions, Inc., Longmont, CO, USA) |
| 246 | 1 | 3 | |a International Conference on Harmonization quality guidelines |
| 250 | |a First edition | ||
| 264 | 1 | |a Hoboken, NJ |b Wiley |c 2018 | |
| 300 | |a 1 Online-Ressource | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b c |2 rdamedia | ||
| 338 | |b cr |2 rdacarrier | ||
| 520 | |a "Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies. Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines. Uses case studies to help readers understand and apply ICH guidelines. Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines. Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)"-- | ||
| 650 | 4 | |a MEDICAL / Pharmacology / bisacsh | |
| 650 | 4 | |a TECHNOLOGY & ENGINEERING / Quality Control / bisacsh | |
| 650 | 4 | |a SCIENCE / Chemistry / Industrial & Technical / bisacsh | |
| 650 | 4 | |a Drug development / fast / (OCoLC)fst00898670 | |
| 650 | 4 | |a Drugs / Quality control / fast / (OCoLC)fst00898891 | |
| 650 | 4 | |a Drugs / Testing / fast / (OCoLC)fst00898940 | |
| 650 | 4 | |a MEDICAL / Pharmacology / bisacsh | |
| 650 | 4 | |a Drug development | |
| 650 | 4 | |a Drugs / Testing | |
| 650 | 4 | |a Drugs / Quality control | |
| 700 | 1 | |a Teasdale, Anthony |d 1957- |0 (DE-588)170666131 |4 edt | |
| 700 | 1 | |a Elder, David |4 edt | |
| 700 | 1 | |a Nims, Raymond W. |4 edt | |
| 776 | 0 | 8 | |i Erscheint auch als |n Druck-Ausgabe |z 9781118971116 |
| 856 | 4 | 0 | |u https://onlinelibrary.wiley.com/doi/book/10.1002/9781118971147 |x Verlag |z URL des Erstveröffentlichers |3 Volltext |
| 912 | |a ZDB-35-WIC | ||
| 940 | 1 | |q UBG_PDA_WIC | |
| 999 | |a oai:aleph.bib-bvb.de:BVB01-030051800 | ||
| 966 | e | |u https://onlinelibrary.wiley.com/doi/book/10.1002/9781118971147 |l FRO01 |p ZDB-35-WIC |q FRO_PDA_WIC |x Verlag |3 Volltext | |
| 966 | e | |u https://onlinelibrary.wiley.com/doi/book/10.1002/9781118971147 |l UBG01 |p ZDB-35-WIC |q UBG_PDA_WIC |x Verlag |3 Volltext | |
| 966 | e | |u https://onlinelibrary.wiley.com/doi/book/10.1002/9781118971147 |l UER01 |p ZDB-35-WIC |q UER_PDA_WIC_Kauf_2024 |x Verlag |3 Volltext | |
Datensatz im Suchindex
| _version_ | 1804178085174575105 |
|---|---|
| any_adam_object | |
| author2 | Teasdale, Anthony 1957- Elder, David Nims, Raymond W. |
| author2_role | edt edt edt |
| author2_variant | a t at d e de r w n rw rwn |
| author_GND | (DE-588)170666131 |
| author_facet | Teasdale, Anthony 1957- Elder, David Nims, Raymond W. |
| building | Verbundindex |
| bvnumber | BV044654140 |
| classification_rvk | VX 5500 |
| collection | ZDB-35-WIC |
| ctrlnum | (OCoLC)1013522330 (DE-599)BVBBV044654140 |
| dewey-full | 615.1/9 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615.1/9 |
| dewey-search | 615.1/9 |
| dewey-sort | 3615.1 19 |
| dewey-tens | 610 - Medicine and health |
| discipline | Chemie / Pharmazie Medizin |
| edition | First edition |
| format | Electronic eBook |
| fullrecord | <?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>03382nmm a2200565zc 4500</leader><controlfield tag="001">BV044654140</controlfield><controlfield tag="003">DE-604</controlfield><controlfield tag="005">20240416 </controlfield><controlfield tag="007">cr|uuu---uuuuu</controlfield><controlfield tag="008">171128s2018 |||| o||u| ||||||eng d</controlfield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">9781118971147</subfield><subfield code="c">Online</subfield><subfield code="9">9781118971147</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">9781118971123</subfield><subfield code="c">Online, ePDF</subfield><subfield code="9">9781118971123</subfield></datafield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1002/9781118971147</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(OCoLC)1013522330</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)BVBBV044654140</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-604</subfield><subfield code="b">ger</subfield><subfield code="e">rda</subfield></datafield><datafield tag="041" ind1="0" ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="049" ind1=" " ind2=" "><subfield code="a">DE-861</subfield><subfield code="a">DE-29</subfield></datafield><datafield tag="082" ind1="0" ind2=" "><subfield code="a">615.1/9</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">VX 5500</subfield><subfield code="0">(DE-625)147800:253</subfield><subfield code="2">rvk</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">ICH quality guidelines</subfield><subfield code="b">an implementation guide</subfield><subfield code="c">edited by Andrew Teasdale (AstraZeneca, London, UK), David Elder (Consultant (former GSK), Hertford, Hertfordshire, UK), Raymond W. Nims (RMC Pharmaceutical Solutions, Inc., Longmont, CO, USA)</subfield></datafield><datafield tag="246" ind1="1" ind2="3"><subfield code="a">International Conference on Harmonization quality guidelines</subfield></datafield><datafield tag="250" ind1=" " ind2=" "><subfield code="a">First edition</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="a">Hoboken, NJ</subfield><subfield code="b">Wiley</subfield><subfield code="c">2018</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="a">1 Online-Ressource</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">"Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies. Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines. Uses case studies to help readers understand and apply ICH guidelines. Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines. Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)"--</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">MEDICAL / Pharmacology / bisacsh</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">TECHNOLOGY & ENGINEERING / Quality Control / bisacsh</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">SCIENCE / Chemistry / Industrial & Technical / bisacsh</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Drug development / fast / (OCoLC)fst00898670</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Drugs / Quality control / fast / (OCoLC)fst00898891</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Drugs / Testing / fast / (OCoLC)fst00898940</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">MEDICAL / Pharmacology / bisacsh</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Drug development</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Drugs / Testing</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Drugs / Quality control</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Teasdale, Anthony</subfield><subfield code="d">1957-</subfield><subfield code="0">(DE-588)170666131</subfield><subfield code="4">edt</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Elder, David</subfield><subfield code="4">edt</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Nims, Raymond W.</subfield><subfield code="4">edt</subfield></datafield><datafield tag="776" ind1="0" ind2="8"><subfield code="i">Erscheint auch als</subfield><subfield code="n">Druck-Ausgabe</subfield><subfield code="z">9781118971116</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://onlinelibrary.wiley.com/doi/book/10.1002/9781118971147</subfield><subfield code="x">Verlag</subfield><subfield code="z">URL des Erstveröffentlichers</subfield><subfield code="3">Volltext</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">ZDB-35-WIC</subfield></datafield><datafield tag="940" ind1="1" ind2=" "><subfield code="q">UBG_PDA_WIC</subfield></datafield><datafield tag="999" ind1=" " ind2=" "><subfield code="a">oai:aleph.bib-bvb.de:BVB01-030051800</subfield></datafield><datafield tag="966" ind1="e" ind2=" "><subfield code="u">https://onlinelibrary.wiley.com/doi/book/10.1002/9781118971147</subfield><subfield code="l">FRO01</subfield><subfield code="p">ZDB-35-WIC</subfield><subfield code="q">FRO_PDA_WIC</subfield><subfield code="x">Verlag</subfield><subfield code="3">Volltext</subfield></datafield><datafield tag="966" ind1="e" ind2=" "><subfield code="u">https://onlinelibrary.wiley.com/doi/book/10.1002/9781118971147</subfield><subfield code="l">UBG01</subfield><subfield code="p">ZDB-35-WIC</subfield><subfield code="q">UBG_PDA_WIC</subfield><subfield code="x">Verlag</subfield><subfield code="3">Volltext</subfield></datafield><datafield tag="966" ind1="e" ind2=" "><subfield code="u">https://onlinelibrary.wiley.com/doi/book/10.1002/9781118971147</subfield><subfield code="l">UER01</subfield><subfield code="p">ZDB-35-WIC</subfield><subfield code="q">UER_PDA_WIC_Kauf_2024</subfield><subfield code="x">Verlag</subfield><subfield code="3">Volltext</subfield></datafield></record></collection> |
| id | DE-604.BV044654140 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-10T07:58:22Z |
| institution | BVB |
| isbn | 9781118971147 9781118971123 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-030051800 |
| oclc_num | 1013522330 |
| open_access_boolean | |
| owner | DE-861 DE-29 |
| owner_facet | DE-861 DE-29 |
| physical | 1 Online-Ressource |
| psigel | ZDB-35-WIC UBG_PDA_WIC ZDB-35-WIC FRO_PDA_WIC ZDB-35-WIC UBG_PDA_WIC ZDB-35-WIC UER_PDA_WIC_Kauf_2024 |
| publishDate | 2018 |
| publishDateSearch | 2018 |
| publishDateSort | 2018 |
| publisher | Wiley |
| record_format | marc |
| spelling | ICH quality guidelines an implementation guide edited by Andrew Teasdale (AstraZeneca, London, UK), David Elder (Consultant (former GSK), Hertford, Hertfordshire, UK), Raymond W. Nims (RMC Pharmaceutical Solutions, Inc., Longmont, CO, USA) International Conference on Harmonization quality guidelines First edition Hoboken, NJ Wiley 2018 1 Online-Ressource txt rdacontent c rdamedia cr rdacarrier "Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies. Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines. Uses case studies to help readers understand and apply ICH guidelines. Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines. Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)"-- MEDICAL / Pharmacology / bisacsh TECHNOLOGY & ENGINEERING / Quality Control / bisacsh SCIENCE / Chemistry / Industrial & Technical / bisacsh Drug development / fast / (OCoLC)fst00898670 Drugs / Quality control / fast / (OCoLC)fst00898891 Drugs / Testing / fast / (OCoLC)fst00898940 Drug development Drugs / Testing Drugs / Quality control Teasdale, Anthony 1957- (DE-588)170666131 edt Elder, David edt Nims, Raymond W. edt Erscheint auch als Druck-Ausgabe 9781118971116 https://onlinelibrary.wiley.com/doi/book/10.1002/9781118971147 Verlag URL des Erstveröffentlichers Volltext |
| spellingShingle | ICH quality guidelines an implementation guide MEDICAL / Pharmacology / bisacsh TECHNOLOGY & ENGINEERING / Quality Control / bisacsh SCIENCE / Chemistry / Industrial & Technical / bisacsh Drug development / fast / (OCoLC)fst00898670 Drugs / Quality control / fast / (OCoLC)fst00898891 Drugs / Testing / fast / (OCoLC)fst00898940 Drug development Drugs / Testing Drugs / Quality control |
| title | ICH quality guidelines an implementation guide |
| title_alt | International Conference on Harmonization quality guidelines |
| title_auth | ICH quality guidelines an implementation guide |
| title_exact_search | ICH quality guidelines an implementation guide |
| title_full | ICH quality guidelines an implementation guide edited by Andrew Teasdale (AstraZeneca, London, UK), David Elder (Consultant (former GSK), Hertford, Hertfordshire, UK), Raymond W. Nims (RMC Pharmaceutical Solutions, Inc., Longmont, CO, USA) |
| title_fullStr | ICH quality guidelines an implementation guide edited by Andrew Teasdale (AstraZeneca, London, UK), David Elder (Consultant (former GSK), Hertford, Hertfordshire, UK), Raymond W. Nims (RMC Pharmaceutical Solutions, Inc., Longmont, CO, USA) |
| title_full_unstemmed | ICH quality guidelines an implementation guide edited by Andrew Teasdale (AstraZeneca, London, UK), David Elder (Consultant (former GSK), Hertford, Hertfordshire, UK), Raymond W. Nims (RMC Pharmaceutical Solutions, Inc., Longmont, CO, USA) |
| title_short | ICH quality guidelines |
| title_sort | ich quality guidelines an implementation guide |
| title_sub | an implementation guide |
| topic | MEDICAL / Pharmacology / bisacsh TECHNOLOGY & ENGINEERING / Quality Control / bisacsh SCIENCE / Chemistry / Industrial & Technical / bisacsh Drug development / fast / (OCoLC)fst00898670 Drugs / Quality control / fast / (OCoLC)fst00898891 Drugs / Testing / fast / (OCoLC)fst00898940 Drug development Drugs / Testing Drugs / Quality control |
| topic_facet | MEDICAL / Pharmacology / bisacsh TECHNOLOGY & ENGINEERING / Quality Control / bisacsh SCIENCE / Chemistry / Industrial & Technical / bisacsh Drug development / fast / (OCoLC)fst00898670 Drugs / Quality control / fast / (OCoLC)fst00898891 Drugs / Testing / fast / (OCoLC)fst00898940 Drug development Drugs / Testing Drugs / Quality control |
| url | https://onlinelibrary.wiley.com/doi/book/10.1002/9781118971147 |
| work_keys_str_mv | AT teasdaleanthony ichqualityguidelinesanimplementationguide AT elderdavid ichqualityguidelinesanimplementationguide AT nimsraymondw ichqualityguidelinesanimplementationguide AT teasdaleanthony internationalconferenceonharmonizationqualityguidelines AT elderdavid internationalconferenceonharmonizationqualityguidelines AT nimsraymondw internationalconferenceonharmonizationqualityguidelines |