|
|
|
|
| LEADER |
01000cam a22002652 4500 |
| 001 |
1653043822 |
| 003 |
DE-627 |
| 005 |
20230428193321.0 |
| 007 |
cr ||||||||||| |
| 008 |
131106s2013 xxu|||||o 00| ||eng c |
| 020 |
|
|
|a 9781461479789
|9 978-1-4614-7978-9
|
| 020 |
|
|
|a 9781461479772
|c Print
|9 978-1-4614-7977-2
|
| 024 |
7 |
|
|a 10.1007/978-1-4614-7978-9
|2 doi
|
| 035 |
|
|
|a (DE-627)1653043822
|
| 035 |
|
|
|a (DE-576)395813727
|
| 035 |
|
|
|a (DE-599)BSZ395813727
|
| 035 |
|
|
|a (OCoLC)865039193
|
| 035 |
|
|
|a (DE-604)BV041360491
|
| 035 |
|
|
|a (DE-He213)978-1-4614-7978-9
|
| 040 |
|
|
|a DE-627
|b ger
|c DE-627
|e rakwb
|
| 041 |
|
|
|a eng
|
| 044 |
|
|
|c XD-US
|
| 050 |
|
0 |
|a RS380
|a RS190-210
|
| 050 |
|
0 |
|a RS199 .S73
|
| 050 |
|
0 |
|a RS380
|
| 072 |
|
7 |
|a TDCW
|2 bicssc
|
| 072 |
|
7 |
|a MED072000
|2 bisacsh
|
| 084 |
|
|
|a VX 8300
|q SEPA
|2 rvk
|0 (DE-625)rvk/147825:253
|
| 084 |
|
|
|a 58.28
|2 bkl
|
| 100 |
1 |
|
|a Kolhe, Parag
|e verfasserin
|4 aut
|
| 245 |
1 |
0 |
|a Sterile Product Development
|b Formulation, Process, Quality and Regulatory Considerations
|c edited by Parag Kolhe, Mrinal Shah, Nitin Rathore
|
| 264 |
|
1 |
|a New York, NY [u.a.]
|b Springer
|c 2013
|
| 300 |
|
|
|a Online-Ressource (XVI, 585 p. 89 illus., 67 illus. in color, online resource)
|
| 336 |
|
|
|a Text
|b txt
|2 rdacontent
|
| 337 |
|
|
|a Computermedien
|b c
|2 rdamedia
|
| 338 |
|
|
|a Online-Ressource
|b cr
|2 rdacarrier
|
| 490 |
0 |
|
|a AAPS Advances in the Pharmaceutical Sciences Series
|v 6
|
| 490 |
0 |
|
|a SpringerLink
|a Bücher
|
| 500 |
|
|
|a Description based upon print version of record
|
| 505 |
8 |
0 |
|a Preface; Acknowledgments; Contents; Contributors; Part I: Formulation Approaches for Sterile Products; Chapter 1: Basic Principles of Sterile Product Formulation Development; 1.1 Introduction; 1.1.1 ICH and the Q8 Guidance Document; 1.1.2 The ICH Q8 Guidance and Quality by Design; 1.1.2.1 Design Space; Raw Materials; Container/Closure Systems; Manufacturing Process; 1.1.3 Pharmaceutical Development Report; 1.2 Active Pharmaceutical Ingredient; 1.3 Drug Product Formulation; 1.3.1 Formulation Identification; 1.3.1.1 Aqueous Solutions; 1.3.1.2 Lipophilic Systems; 1.3.1.3 Suspensions
|
| 505 |
8 |
0 |
|a 1.3.1.4 Dry Formulations1.3.1.5 Implants; 1.3.2 Formulation Development; 1.3.2.1 A Note on Excipients; 1.3.2.2 Buffering Agents and pH; 1.3.2.3 Tonicity Agents and Osmolality; 1.3.2.4 Antioxidants; 1.3.2.5 Preservatives; 1.3.2.6 Bulking Agents and Cryoprotectants; 1.4 Stability and Compatibility; 1.4.1 Oxidation; 1.4.2 Thermal Stability; 1.4.3 Photostability; 1.4.4 Material Contact Compatibility; 1.4.4.1 Primary Packaging; 1.4.4.2 Equipment Materials of Construction Compatibility; 1.4.5 General Long-Term Stability Considerations; 1.5 Processability and Scalability; 1.5.1 Compounding
|
| 505 |
8 |
0 |
|a 1.5.2 Filling1.5.3 Sterilization; 1.5.4 General Processing Requirements; 1.6 Other Considerations; 1.7 Conclusions; References; Chapter 2: Molecule and Manufacturability Assessment Leading to Robust Commercial Formulation for Therapeutic Proteins; 2.1 Introduction; 2.2 Molecule Assessment; 2.2.1 Protein Sequence Analysis and Assessment of Product Quality; 2.2.2 Assessment of Physical Stability; 2.2.2.1 Recommendation of Initial Formulation for a Single Candidate: Assessment of Stability at Different pH Conditions; 2.2.2.2 Stability of Several Candidate Molecules at a Single pH
|
| 505 |
8 |
0 |
|a 2.2.2.3 Stability to Physiological pH Conditions2.2.2.4 Stability to Low pH Conditions; 2.2.3 Solubility and Viscosity; 2.2.4 Stability to Agitation-Induced Particulation; 2.2.5 Chemical Stability; 2.3 Manufacturability Assessment; 2.3.1 Freeze-Thaw; 2.3.2 Filtration; 2.4 Summary; References; Chapter 3: Polymer- and Lipid-Based Systems for Parenteral Drug Delivery; 3.1 Introduction; 3.2 Polymer-Based In Situ Forming Semisolid (Gel) Depots; 3.2.1 Solvent-Precipitating Depot Formulations; 3.2.1.1 Atrigel Drug Delivery Technology; 3.2.1.2 Sucrose Acetate Isobutyrate-Based Formulations
|
| 505 |
8 |
0 |
|a 3.2.2 Stimuli-Responsive Injectable Depots3.3 Formulation Development of Lipid-Drug Delivery Systems; 3.3.1 Preparation and Characterization of Liposomes; 3.3.1.1 Ultrasonication Irradiation; 3.3.1.2 High-Pressure Homogenization or Extrusion; 3.3.1.3 Drug Loading; 3.3.1.4 Effect of Lipid Composition on Size and Surface Characteristics; 3.3.2 Representative FDA-Approved Liposomal Formulations; 3.3.3 Targeted In Vivo Delivery Using Liposomal Formulations: Stealth Liposomes and Immunoliposomes; 3.3.3.1 Effect of Lipid Composition on In Vivo Fate: Stealth Liposomes
|
| 505 |
8 |
0 |
|a 3.3.3.2 Active Targeting: Immunoliposomes
|
| 520 |
|
|
|a This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable com
|
| 650 |
|
0 |
|a Medicine
|
| 650 |
|
0 |
|a Pharmaceutical technology
|
| 650 |
|
0 |
|a Biomedicine
|
| 650 |
|
0 |
|a Medicine
|
| 650 |
|
0 |
|a Pharmaceutical technology
|
| 689 |
0 |
0 |
|D s
|0 (DE-588)4295343-1
|0 (DE-627)104175435
|0 (DE-576)210969113
|a Sterilität
|g Hygiene
|2 gnd
|
| 689 |
0 |
1 |
|D s
|0 (DE-588)4169805-8
|0 (DE-627)105407186
|0 (DE-576)209925337
|a Mikrobielle Kontamination
|2 gnd
|
| 689 |
0 |
2 |
|D s
|0 (DE-588)4045699-7
|0 (DE-627)104162406
|0 (DE-576)209066407
|a Pharmazeutische Technologie
|2 gnd
|
| 689 |
0 |
|
|5 (DE-627)
|
| 700 |
1 |
|
|a Shah, Mrinal
|e hrsg
|4 edt
|
| 700 |
1 |
|
|a Rathore, Nitin
|e hrsg
|4 edt
|
| 776 |
1 |
|
|z 9781461479772
|
| 776 |
0 |
8 |
|i Druckausg.
|t Sterile product development
|d New York, NY [u.a.] : Springer [u.a.], 2013
|h XVI, 585 S.
|w (DE-627)775852538
|z 9781461479772
|z 9781461479789
|
| 856 |
4 |
0 |
|u https://doi.org/10.1007/978-1-4614-7978-9
|x Verlag
|3 Volltext
|
| 856 |
4 |
0 |
|u http://dx.doi.org/10.1007/978-1-4614-7978-9
|x Verlag
|3 Volltext
|
| 856 |
4 |
2 |
|u https://swbplus.bsz-bw.de/bsz395813727cov.jpg
|m V:DE-576
|m X:springer
|q image/jpeg
|v 20150327163408
|3 Cover
|
| 856 |
4 |
2 |
|u http://www.gbv.de/dms/bowker/toc/9781461479772.pdf
|m V:DE-601
|m X:Bowker
|q pdf/application
|v 2014-03-19
|x Verlag
|y Inhaltsverzeichnis
|3 Inhaltsverzeichnis
|
| 889 |
|
|
|w (DE-627)770416365
|
| 912 |
|
|
|a ZDB-2-SBL
|b 2013
|
| 912 |
|
|
|a GBV_ILN_22
|
| 912 |
|
|
|a ISIL_DE-18
|
| 912 |
|
|
|a SYSFLAG_1
|
| 912 |
|
|
|a GBV_KXP
|
| 912 |
|
|
|a SSG-OLC-PHA
|
| 912 |
|
|
|a GBV_ILN_22_i06404
|
| 912 |
|
|
|a GBV_ILN_40
|
| 912 |
|
|
|a ISIL_DE-7
|
| 912 |
|
|
|a GBV_ILN_65
|
| 912 |
|
|
|a ISIL_DE-3
|
| 912 |
|
|
|a GBV_ILN_100
|
| 912 |
|
|
|a ISIL_DE-Ma9
|
| 912 |
|
|
|a GBV_ILN_101
|
| 912 |
|
|
|a ISIL_DE-Ma14
|
| 912 |
|
|
|a GBV_ILN_120
|
| 912 |
|
|
|a ISIL_DE-715
|
| 912 |
|
|
|a GBV_ILN_285
|
| 912 |
|
|
|a ISIL_DE-517
|
| 912 |
|
|
|a GBV_ILN_2003
|
| 912 |
|
|
|a ISIL_DE-25
|
| 912 |
|
|
|a GBV_ILN_2017
|
| 912 |
|
|
|a ISIL_DE-576
|
| 935 |
|
|
|h GBV
|i ExPruef
|
| 936 |
r |
v |
|a VX 8300
|b Allgemeines
|k Chemie und Pharmazie
|k Pharmazeutische Technologie einschl. Biopharmazie
|k Pharmazeutische Technologie allgemein
|k Arzneiformen und ihre Herstellungsprozesse
|k Sterile Zubereitung
|k Allgemeines
|0 (DE-627)1271913887
|0 (DE-625)rvk/147825:253
|0 (DE-576)201913887
|
| 936 |
b |
k |
|a 58.28
|j Pharmazeutische Technologie
|q SEPA
|0 (DE-627)106417622
|
| 951 |
|
|
|a BO
|
| 953 |
|
|
|2 045F
|a 615.19
|
| 953 |
|
|
|2 045F
|a 610.72
|
| 980 |
|
|
|2 22
|1 01
|x 0018
|b 3525135661
|c 00
|f --%%--
|d --%%--
|e s
|j --%%--
|h h64 Springer Biomedical
|k Campuslizenz Universität Hamburg. - Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots.
|y zi06404
|z 19-10-19
|
| 980 |
|
|
|2 40
|1 01
|x 0007
|b 1446980561
|h OLR-SPRINGER-SBL
|u nl
|y xsn
|z 26-11-13
|
| 980 |
|
|
|2 65
|1 01
|x 0003
|b 3520245906
|c 03
|f --%%--
|d ebook
|e --%%--
|j --%%--
|h OLR-SEB-ZDB-2-SBL
|k Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Die Weitergabe an Dritte sowie systematisches Downloaden sind untersagt.
|y k3o
|z 08-10-19
|
| 980 |
|
|
|2 100
|1 01
|x 3100
|b 3525215207
|c 00
|f --%%--
|d --%%--
|e s
|j --%%--
|c 09
|f --%%--
|d eBook Springer
|e --%%--
|j --%%--
|h OLR-SEB
|k Vervielfältigungen (z.B. Kopien, Downloads) sind nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots.
|y z
|z 19-10-19
|
| 980 |
|
|
|2 101
|1 01
|x 3101
|b 3525233582
|c 00
|f --%%--
|d --%%--
|e s
|j --%%--
|c 09
|f --%%--
|d eBook Springer
|e --%%--
|j --%%--
|h OLR-SEB
|k Vervielfältigungen (z.B. Kopien, Downloads) sind nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots.
|y z
|z 19-10-19
|
| 980 |
|
|
|2 120
|1 01
|x 0715
|b 352524746X
|h OLR-ESP
|k Campusweiter Zugriff (Universität Oldenburg). - Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden.
|y z
|z 19-10-19
|
| 980 |
|
|
|2 120
|1 02
|x 0715
|b 1447006976
|h OLR-ESP
|k Campusweiter Zugriff (Universität Oldenburg). - Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden.
|y z
|z 26-11-13
|
| 980 |
|
|
|2 120
|1 03
|x 0715
|b 1754933165
|c 00
|f --%%--
|d --%%--
|e g
|j --%%--
|h alma
|k ww
|y z
|z 22-02-18
|
| 980 |
|
|
|2 120
|1 04
|x 0715
|b 3577691786
|c 00
|f --%%--
|d --%%--
|e g
|j --%%--
|h alma
|k ww
|y z
|z 21-01-20
|
| 980 |
|
|
|2 285
|1 01
|x 0517
|b 3525281129
|c 00
|f --%%--
|d --%%--
|e s
|j --%%--
|h OLR-ESP-SBL
|k Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots.
|y z
|z 19-10-19
|
| 980 |
|
|
|2 2003
|1 01
|x DE-25
|b 3362365884
|c 00
|f --%%--
|d --%%--
|e --%%--
|j n
|k Elektronischer Volltext - Universitätslizenz
|y l01
|z 12-10-13
|
| 980 |
|
|
|2 2017
|1 01
|x DE-576
|b 3362365892
|c 00
|f --%%--
|d --%%--
|e --%%--
|j n
|k Besitznachweis BSZ nur für Dateneinspielung, keine echte Lizenz vorhanden
|y l01
|z 12-10-13
|
| 981 |
|
|
|2 22
|1 01
|x 0018
|y Volltextzugang
|r https://doi.org/10.1007/978-1-4614-7978-9
|
| 981 |
|
|
|2 22
|1 01
|x 0018
|y Nur für Angehörige der Universität Hamburg: Volltextzugang von außerhalb des Campus
|r http://emedien.sub.uni-hamburg.de/han/SpringerEbooksUKE/doi.org/10.1007/978-1-4614-7978-9
|
| 981 |
|
|
|2 40
|1 01
|x 0007
|y Volltext, Campuszugriff
|r http://dx.doi.org/10.1007/978-1-4614-7978-9
|
| 981 |
|
|
|2 40
|1 01
|x 0007
|y Volltext, Externer Zugriff
|r http://han.sub.uni-goettingen.de/han/Springer-eBook-BiomedicalLifeScience/dx.doi.org/10.1007/978-1-4614-7978-9
|
| 981 |
|
|
|2 40
|1 01
|x 0007
|y Dieser Titel ist Teil einer Datenbank
|r http://www.bibliothek.uni-regensburg.de/dbinfo/frontdoor.php?titel_id=7893&bibid=SUBGO
|
| 981 |
|
|
|2 65
|1 01
|x 0003
|y Volltextzugang Campus
|r https://doi.org/10.1007/978-1-4614-7978-9
|
| 981 |
|
|
|2 100
|1 01
|x 3100
|r https://doi.org/10.1007/978-1-4614-7978-9
|
| 981 |
|
|
|2 100
|1 01
|x 3100
|y für Uniangehörige: Zugang weltweit
|r https://han.med.uni-magdeburg.de/han/SPR-eBook-BiomedicalandLifeScience-einzeln/doi.org/10.1007/978-1-4614-7978-9
|
| 981 |
|
|
|2 101
|1 01
|x 3101
|r https://doi.org/10.1007/978-1-4614-7978-9
|
| 981 |
|
|
|2 101
|1 01
|x 3101
|y für Uniangehörige: Zugang weltweit
|r https://han.med.uni-magdeburg.de/han/SPR-eBook-BiomedicalandLifeScience-einzeln/doi.org/10.1007/978-1-4614-7978-9
|
| 981 |
|
|
|2 120
|1 01
|x 0715
|r https://doi.org/10.1007/978-1-4614-7978-9
|
| 981 |
|
|
|2 120
|1 02
|x 0715
|r http://dx.doi.org/10.1007/978-1-4614-7978-9
|
| 981 |
|
|
|2 120
|1 03
|x 0715
|r http://49gbv-uob-primo.hosted.exlibrisgroup.com/openurl/49GBV_UOB/UOB_services_page?u.ignore_date_coverage=true&rft.mms_id=991016133869803501
|
| 981 |
|
|
|2 120
|1 04
|x 0715
|r http://49gbv-uob-primo.hosted.exlibrisgroup.com/openurl/49GBV_UOB/UOB_services_page?u.ignore_date_coverage=true&rft.mms_id=991016133869803501
|
| 981 |
|
|
|2 285
|1 01
|x 0517
|y E-books (Springer)
|r https://doi.org/10.1007/978-1-4614-7978-9
|
| 981 |
|
|
|2 2003
|1 01
|x DE-25
|r http://www.redi-bw.de/start/unifr/EBooks-springer/10.1007/978-1-4614-7978-9
|
| 983 |
|
|
|2 40
|1 00
|x DE-7
|8 00
|0 (DE-627)619875550
|a MED 361
|b Pharmazie
|
| 983 |
|
|
|2 120
|1 00
|x DE-715
|8 99
|a ww
|
| 984 |
|
|
|2 120
|1 02
|x 0715
|a 24895158
|
| 985 |
|
|
|2 22
|1 01
|x 0018
|a h64 ebook
|
| 985 |
|
|
|2 120
|1 01
|x 0715
|a YH 1694
|
| 985 |
|
|
|2 120
|1 02
|x 0715
|a YH 1694
|
| 995 |
|
|
|2 22
|1 01
|x 0018
|a h64 Springer Biomedical
|
| 995 |
|
|
|2 40
|1 01
|x 0007
|a OLR-SPRINGER-SBL
|
| 995 |
|
|
|2 65
|1 01
|x 0003
|a OLR-SEB-ZDB-2-SBL
|
| 995 |
|
|
|2 100
|1 01
|x 3100
|a OLR-SEB
|
| 995 |
|
|
|2 101
|1 01
|x 3101
|a OLR-SEB
|
| 995 |
|
|
|2 120
|1 01
|x 0715
|a OLR-ESP
|
| 995 |
|
|
|2 120
|1 02
|x 0715
|a OLR-ESP
|
| 995 |
|
|
|2 120
|1 03
|x 0715
|a alma
|
| 995 |
|
|
|2 120
|1 04
|x 0715
|a alma
|
| 995 |
|
|
|2 285
|1 01
|x 0517
|a OLR-ESP-SBL
|
