Development of specifications for biotechnology pharmaceutical products: Hyatt Regency, San Francisco CA, USA, May 2 - 3, 1996 ; proceedings of a symposium ; 16 tables
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | German |
| Veröffentlicht: |
Basel [u.a.]
Karger
1997
|
| Schriftenreihe: | Developments in biological standardization
91 |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | Literaturangaben |
| Beschreibung: | X, 117 S. graph. Darst. |
| ISBN: | 3805565690 |
Internformat
MARC
| LEADER | 00000nam a2200000 cb4500 | ||
|---|---|---|---|
| 001 | BV011715824 | ||
| 003 | DE-604 | ||
| 005 | 20210702 | ||
| 007 | t | ||
| 008 | 980106s1997 gw d||| |||| 10||| ger d | ||
| 016 | 7 | |a 952303833 |2 DE-101 | |
| 020 | |a 3805565690 |c kart. : DM 144.00 |9 3-8055-6569-0 | ||
| 035 | |a (OCoLC)214956436 | ||
| 035 | |a (DE-599)BVBBV011715824 | ||
| 040 | |a DE-604 |b ger |e rakddb | ||
| 041 | 0 | |a ger | |
| 044 | |a gw |c DE | ||
| 049 | |a DE-12 |a DE-11 | ||
| 084 | |a VN 8900 |0 (DE-625)147633:253 |2 rvk | ||
| 084 | |a VS 5350 |0 (DE-625)147687:253 |2 rvk | ||
| 245 | 1 | 0 | |a Development of specifications for biotechnology pharmaceutical products |b Hyatt Regency, San Francisco CA, USA, May 2 - 3, 1996 ; proceedings of a symposium ; 16 tables |c organized and sponsored by the PDA West Coast Chapter and International Association of Biological Standardization (IABS). Vol. ed. Fred Brown ; James Fernandez |
| 264 | 1 | |a Basel [u.a.] |b Karger |c 1997 | |
| 300 | |a X, 117 S. |b graph. Darst. | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 490 | 1 | |a Developments in biological standardization |v 91 | |
| 500 | |a Literaturangaben | ||
| 650 | 0 | 7 | |a Herstellung |0 (DE-588)4159653-5 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Biotechnologie |0 (DE-588)4069491-4 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Arzneimittel |0 (DE-588)4003115-9 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Pharmazeutische Technologie |0 (DE-588)4045699-7 |2 gnd |9 rswk-swf |
| 655 | 7 | |0 (DE-588)1071861417 |a Konferenzschrift |y 1996 |z San Francisco Calif. |2 gnd-content | |
| 689 | 0 | 0 | |a Arzneimittel |0 (DE-588)4003115-9 |D s |
| 689 | 0 | 1 | |a Herstellung |0 (DE-588)4159653-5 |D s |
| 689 | 0 | 2 | |a Biotechnologie |0 (DE-588)4069491-4 |D s |
| 689 | 0 | |5 DE-604 | |
| 689 | 1 | 0 | |a Pharmazeutische Technologie |0 (DE-588)4045699-7 |D s |
| 689 | 1 | 1 | |a Biotechnologie |0 (DE-588)4069491-4 |D s |
| 689 | 1 | |5 DE-604 | |
| 700 | 1 | |a Brown, Fred |d 1925-2004 |e Sonstige |0 (DE-588)171991923 |4 oth | |
| 710 | 2 | |a Parenteral Drug Association |b West Coast Chapter |e Sonstige |0 (DE-588)2167431-0 |4 oth | |
| 830 | 0 | |a Developments in biological standardization |v 91 |w (DE-604)BV000000884 |9 91 | |
| 856 | 4 | 2 | |m HBZ Datenaustausch |q application/pdf |u http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=007900783&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |3 Inhaltsverzeichnis |
| 999 | |a oai:aleph.bib-bvb.de:BVB01-007900783 | ||
Datensatz im Suchindex
| _version_ | 1804126253942308864 |
|---|---|
| adam_text | Contents
Session I
Global Perspective on Specifications for Biotechnology Products 1
Moderator: Robert Baffi, Ph.D.
FDA Perspective on Specifications for Biotechnology Products from IND to PLA 3
G. Murano
Global Perspective on Specifications for Biotechnology Products Perspective from Japan .. 15
T. Hayakawa
Development of Specifications for Biotechnology Products Perspective from Europe 25
J.H. Trouvin
Specifications from a Biotechnology Industry Perspective 31
R.L. Garnick
Session II
Evolution of Specifications Through Product Development 37
Moderator: Vincent Anicetti, M.S.
Appropriate Specifications at the IND Stage 39
J. Geigert
Global Regulatory Considerations for Unified Assay Specifications 45
5. Patterson, L. Lin, J. Elchico, R. Fuchs, S. Powell, D. Redhair, M. Warwick.
N. Solli, B. Mendez
Characterization and Establishment of Specifications for Biopharmaceuticals 49
G.C. Davis, R.M. Riggin
Workshop I
Environmental Control 55
Workshop Summary 57
J. Fernandez
Workshop II
Specifications: What is Necessary to Start Clinical Trials? 59
Workshop Summary 61
J. Fernandez
IX
Session III
Specifications Within the Manufacturing Operation 63
Moderator: Florian Horaud, IABS
Raw Material Considerations 65
A.S. Lubiniecki, P.J. Shadle
In Process Testing and Limits 73
/. Sjoholm
The Use of Bioassays for the Characterisation and Control of Biological Therapeutic Pro¬
ducts Produced by Biotechnology 79
R. Thorpe, M. Wadhwa, A. Mire Sluis
Workshop III
In Process Testing/Limits 89
Workshop Summary 91
/ Fernandez
Workshop IV
Reference Standards/Materials 95
Workshop Summary 97
/ Fernandez
Session IV
Role of the Pharmacopoeia and Validation in Specification Development 103
Moderator: Jean Huxsoll, M.S.
The Role of Assay Validation in Specification Development 105
R.A. Baffi
X Contents
|
| any_adam_object | 1 |
| author_GND | (DE-588)171991923 |
| building | Verbundindex |
| bvnumber | BV011715824 |
| classification_rvk | VN 8900 VS 5350 |
| ctrlnum | (OCoLC)214956436 (DE-599)BVBBV011715824 |
| discipline | Chemie / Pharmazie |
| format | Book |
| fullrecord | <?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>02392nam a2200505 cb4500</leader><controlfield tag="001">BV011715824</controlfield><controlfield tag="003">DE-604</controlfield><controlfield tag="005">20210702 </controlfield><controlfield tag="007">t</controlfield><controlfield tag="008">980106s1997 gw d||| |||| 10||| ger d</controlfield><datafield tag="016" ind1="7" ind2=" "><subfield code="a">952303833</subfield><subfield code="2">DE-101</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">3805565690</subfield><subfield code="c">kart. : DM 144.00</subfield><subfield code="9">3-8055-6569-0</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(OCoLC)214956436</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)BVBBV011715824</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-604</subfield><subfield code="b">ger</subfield><subfield code="e">rakddb</subfield></datafield><datafield tag="041" ind1="0" ind2=" "><subfield code="a">ger</subfield></datafield><datafield tag="044" ind1=" " ind2=" "><subfield code="a">gw</subfield><subfield code="c">DE</subfield></datafield><datafield tag="049" ind1=" " ind2=" "><subfield code="a">DE-12</subfield><subfield code="a">DE-11</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">VN 8900</subfield><subfield code="0">(DE-625)147633:253</subfield><subfield code="2">rvk</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">VS 5350</subfield><subfield code="0">(DE-625)147687:253</subfield><subfield code="2">rvk</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Development of specifications for biotechnology pharmaceutical products</subfield><subfield code="b">Hyatt Regency, San Francisco CA, USA, May 2 - 3, 1996 ; proceedings of a symposium ; 16 tables</subfield><subfield code="c">organized and sponsored by the PDA West Coast Chapter and International Association of Biological Standardization (IABS). Vol. ed. Fred Brown ; James Fernandez</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="a">Basel [u.a.]</subfield><subfield code="b">Karger</subfield><subfield code="c">1997</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="a">X, 117 S.</subfield><subfield code="b">graph. Darst.</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">n</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="b">nc</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="490" ind1="1" ind2=" "><subfield code="a">Developments in biological standardization</subfield><subfield code="v">91</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">Literaturangaben</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Herstellung</subfield><subfield code="0">(DE-588)4159653-5</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Biotechnologie</subfield><subfield code="0">(DE-588)4069491-4</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Arzneimittel</subfield><subfield code="0">(DE-588)4003115-9</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Pharmazeutische Technologie</subfield><subfield code="0">(DE-588)4045699-7</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="655" ind1=" " ind2="7"><subfield code="0">(DE-588)1071861417</subfield><subfield code="a">Konferenzschrift</subfield><subfield code="y">1996</subfield><subfield code="z">San Francisco Calif.</subfield><subfield code="2">gnd-content</subfield></datafield><datafield tag="689" ind1="0" ind2="0"><subfield code="a">Arzneimittel</subfield><subfield code="0">(DE-588)4003115-9</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="0" ind2="1"><subfield code="a">Herstellung</subfield><subfield code="0">(DE-588)4159653-5</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="0" ind2="2"><subfield code="a">Biotechnologie</subfield><subfield code="0">(DE-588)4069491-4</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="0" ind2=" "><subfield code="5">DE-604</subfield></datafield><datafield tag="689" ind1="1" ind2="0"><subfield code="a">Pharmazeutische Technologie</subfield><subfield code="0">(DE-588)4045699-7</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="1" ind2="1"><subfield code="a">Biotechnologie</subfield><subfield code="0">(DE-588)4069491-4</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="1" ind2=" "><subfield code="5">DE-604</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Brown, Fred</subfield><subfield code="d">1925-2004</subfield><subfield code="e">Sonstige</subfield><subfield code="0">(DE-588)171991923</subfield><subfield code="4">oth</subfield></datafield><datafield tag="710" ind1="2" ind2=" "><subfield code="a">Parenteral Drug Association</subfield><subfield code="b">West Coast Chapter</subfield><subfield code="e">Sonstige</subfield><subfield code="0">(DE-588)2167431-0</subfield><subfield code="4">oth</subfield></datafield><datafield tag="830" ind1=" " ind2="0"><subfield code="a">Developments in biological standardization</subfield><subfield code="v">91</subfield><subfield code="w">(DE-604)BV000000884</subfield><subfield code="9">91</subfield></datafield><datafield tag="856" ind1="4" ind2="2"><subfield code="m">HBZ Datenaustausch</subfield><subfield code="q">application/pdf</subfield><subfield code="u">http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=007900783&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA</subfield><subfield code="3">Inhaltsverzeichnis</subfield></datafield><datafield tag="999" ind1=" " ind2=" "><subfield code="a">oai:aleph.bib-bvb.de:BVB01-007900783</subfield></datafield></record></collection> |
| genre | (DE-588)1071861417 Konferenzschrift 1996 San Francisco Calif. gnd-content |
| genre_facet | Konferenzschrift 1996 San Francisco Calif. |
| id | DE-604.BV011715824 |
| illustrated | Illustrated |
| indexdate | 2024-07-09T18:14:31Z |
| institution | BVB |
| institution_GND | (DE-588)2167431-0 |
| isbn | 3805565690 |
| language | German |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-007900783 |
| oclc_num | 214956436 |
| open_access_boolean | |
| owner | DE-12 DE-11 |
| owner_facet | DE-12 DE-11 |
| physical | X, 117 S. graph. Darst. |
| publishDate | 1997 |
| publishDateSearch | 1997 |
| publishDateSort | 1997 |
| publisher | Karger |
| record_format | marc |
| series | Developments in biological standardization |
| series2 | Developments in biological standardization |
| spelling | Development of specifications for biotechnology pharmaceutical products Hyatt Regency, San Francisco CA, USA, May 2 - 3, 1996 ; proceedings of a symposium ; 16 tables organized and sponsored by the PDA West Coast Chapter and International Association of Biological Standardization (IABS). Vol. ed. Fred Brown ; James Fernandez Basel [u.a.] Karger 1997 X, 117 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Developments in biological standardization 91 Literaturangaben Herstellung (DE-588)4159653-5 gnd rswk-swf Biotechnologie (DE-588)4069491-4 gnd rswk-swf Arzneimittel (DE-588)4003115-9 gnd rswk-swf Pharmazeutische Technologie (DE-588)4045699-7 gnd rswk-swf (DE-588)1071861417 Konferenzschrift 1996 San Francisco Calif. gnd-content Arzneimittel (DE-588)4003115-9 s Herstellung (DE-588)4159653-5 s Biotechnologie (DE-588)4069491-4 s DE-604 Pharmazeutische Technologie (DE-588)4045699-7 s Brown, Fred 1925-2004 Sonstige (DE-588)171991923 oth Parenteral Drug Association West Coast Chapter Sonstige (DE-588)2167431-0 oth Developments in biological standardization 91 (DE-604)BV000000884 91 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=007900783&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Development of specifications for biotechnology pharmaceutical products Hyatt Regency, San Francisco CA, USA, May 2 - 3, 1996 ; proceedings of a symposium ; 16 tables Developments in biological standardization Herstellung (DE-588)4159653-5 gnd Biotechnologie (DE-588)4069491-4 gnd Arzneimittel (DE-588)4003115-9 gnd Pharmazeutische Technologie (DE-588)4045699-7 gnd |
| subject_GND | (DE-588)4159653-5 (DE-588)4069491-4 (DE-588)4003115-9 (DE-588)4045699-7 (DE-588)1071861417 |
| title | Development of specifications for biotechnology pharmaceutical products Hyatt Regency, San Francisco CA, USA, May 2 - 3, 1996 ; proceedings of a symposium ; 16 tables |
| title_auth | Development of specifications for biotechnology pharmaceutical products Hyatt Regency, San Francisco CA, USA, May 2 - 3, 1996 ; proceedings of a symposium ; 16 tables |
| title_exact_search | Development of specifications for biotechnology pharmaceutical products Hyatt Regency, San Francisco CA, USA, May 2 - 3, 1996 ; proceedings of a symposium ; 16 tables |
| title_full | Development of specifications for biotechnology pharmaceutical products Hyatt Regency, San Francisco CA, USA, May 2 - 3, 1996 ; proceedings of a symposium ; 16 tables organized and sponsored by the PDA West Coast Chapter and International Association of Biological Standardization (IABS). Vol. ed. Fred Brown ; James Fernandez |
| title_fullStr | Development of specifications for biotechnology pharmaceutical products Hyatt Regency, San Francisco CA, USA, May 2 - 3, 1996 ; proceedings of a symposium ; 16 tables organized and sponsored by the PDA West Coast Chapter and International Association of Biological Standardization (IABS). Vol. ed. Fred Brown ; James Fernandez |
| title_full_unstemmed | Development of specifications for biotechnology pharmaceutical products Hyatt Regency, San Francisco CA, USA, May 2 - 3, 1996 ; proceedings of a symposium ; 16 tables organized and sponsored by the PDA West Coast Chapter and International Association of Biological Standardization (IABS). Vol. ed. Fred Brown ; James Fernandez |
| title_short | Development of specifications for biotechnology pharmaceutical products |
| title_sort | development of specifications for biotechnology pharmaceutical products hyatt regency san francisco ca usa may 2 3 1996 proceedings of a symposium 16 tables |
| title_sub | Hyatt Regency, San Francisco CA, USA, May 2 - 3, 1996 ; proceedings of a symposium ; 16 tables |
| topic | Herstellung (DE-588)4159653-5 gnd Biotechnologie (DE-588)4069491-4 gnd Arzneimittel (DE-588)4003115-9 gnd Pharmazeutische Technologie (DE-588)4045699-7 gnd |
| topic_facet | Herstellung Biotechnologie Arzneimittel Pharmazeutische Technologie Konferenzschrift 1996 San Francisco Calif. |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=007900783&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| volume_link | (DE-604)BV000000884 |
| work_keys_str_mv | AT brownfred developmentofspecificationsforbiotechnologypharmaceuticalproductshyattregencysanfranciscocausamay231996proceedingsofasymposium16tables AT parenteraldrugassociationwestcoastchapter developmentofspecificationsforbiotechnologypharmaceuticalproductshyattregencysanfranciscocausamay231996proceedingsofasymposium16tables |