Quality by Design for Biopharmaceutical Drug Product Development:
Gespeichert in:
| Format: | Elektronisch E-Book |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
New York, NY [u.a.]
Springer
2015
|
| Schriftenreihe: | AAPS Advances in the Pharmaceutical Sciences Series
18 |
| Schlagworte: | |
| Online-Zugang: | TUM01 UBT01 Volltext Inhaltsverzeichnis Abstract |
| Beschreibung: | 1 Online-Ressource (XX, 710 p. 214 illus., 163 illus. in color) |
| ISBN: | 9781493923168 |
| DOI: | 10.1007/978-1-4939-2316-8 |
Internformat
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| 245 | 1 | 0 | |a Quality by Design for Biopharmaceutical Drug Product Development |c Feroz Jameel, Susan Hershenson, Mansoor A. Khan, Sheryl Martin-Moe, ed. |
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Datensatz im Suchindex
| _version_ | 1804153309625319424 |
|---|---|
| adam_text | QUALITY BY DESIGN FOR BIOPHARMACEUTICAL DRUG PRODUCT DEVELOPMENT
/ JAMEEL, FEROZ
: 2015
TABLE OF CONTENTS / INHALTSVERZEICHNIS
1 CHALLENGES AND OPPORTUNITIES FOR BIOTECH QUALITY BY DESIGN
2 LESSONS LEARNED FROM MONOCLONAL ANTIBODY APPLICATIONS TO THE OFFICE OF
BIOTECHNOLOGY PRODUCTS QUALITY BY DESIGN PILOT PROGRAM
3 DEFINITIONS AND SCOPE OF KEY ELEMENTS OF QBD
4 AN OVERVIEW OF QUALITY BY DESIGN FOR DRUG PRODUCT
5 DEVELOPMENT OF DRUG PRODUCT FORMULATIONS: MOLECULAR DESIGN AND EARLY
CANDIDATES SCREENING
6 APPROACHES FOR EARLY DEVELOPABILITY ASSESSMENT OF PROTEINS TO GUIDE
QUALITY BY DESIGN OF LIQUID FORMULATIONS
7 APPLICATION OF QBD PRINCIPLES TO LATE-STAGE FORMULATION DEVELOPMENT
FOR BIOLOGICAL LIQUID PRODUCTS
8 APPLICATION OF QBD PRINCIPLES FOR LYOPHILIZED FORMULATION DEVELOPMENT
9 DRUG SUBSTANCE FROZEN STORAGE AND THAWING
10 QUALITY BY DESIGN AS APPLIED TO DRUG SUBSTANCE FORMULATION USING
ULTRAFILTRATION AND DIAFILTRATION
11 A QBD APPROACH IN THE DEVELOPMENT AND SCALE-UP OF MIXING PROCESSES
12 APPLICATION OF QBD ELEMENTS IN THE DEVELOPMENT AND SCALE-UP OF A
COMMERCIAL FILTRATION PROCESS
13 APPLICATION OF QBD ELEMENTS IN THE DEVELOPMENT AND SCALE-UP OF
COMMERCIAL FILLING PROCESS
14 LYOPHILIZATION PROCESS DESIGN AND DEVELOPMENT USING QBD PRINCIPLES
15 VISIBLE AND SUBVISIBLE PROTEIN PARTICLE INSPECTION WITHIN A QBD-BASED
STRATEGY
16 QUALITY BY DESIGN FOR DISTRIBUTION OF ENVIRONMENTALLY SENSITIVE
PHARMACEUTICAL PRODUCTS
17 QUALITY BY DESIGN FOR PRIMARY CONTAINER COMPONENTS
18 DEVICES AND COMBINATION PRODUCTS FOR BIOPHARMACEUTICALS
19 APPLICABILITY OF QBD FOR VACCINE DRUG PRODUCT DEVELOPMENT
20 AUTOMATION AND HIGH THROUGHPUT TECHNOLOGIES IN BIOPHARMACEUTICAL DRUG
PRODUCT DEVELOPMENT WITH QBD APPROACHES
21 CRITICAL QUALITY ATTRIBUTES, SPECIFICATIONS, AND CONTROL STRATEGY
22 MULTIVARIATE ANALYSIS FOR PROCESS UNDERSTANDING, MONITORING, CONTROL
AND OPTIMIZATION IN LYOPHILIZATION PROCESSES
23 USING MATHEMATICAL MODELING AND PRIOR KNOWLEDGE FOR QBD IN
FREEZE-DRYING PROCESSES
24 APPLICATION OF MULTIVARIATE STATISTICAL PROCESS MONITORING TO
LYOPHILIZATION PROCESS
25 APPLICATION OF PAT IN REAL-TIME MONITORING AND CONTROLLING OF
LYOPHILIZATION PROCESS
26 PRODUCT HOMOGENEITY ASSESSMENT DURING VALIDATION OF BIOPHARMACEUTICAL
DRUG PRODUCT MANUFACTURING PROCESSES
27 APPLICATION OF QUALITY BY DESIGN PRINCIPLES TO THE DRUG PRODUCT
TECHNOLOGY TRANSFER PROCESS
28 REGULATORY CONSIDERATIONS FOR IMPLEMENTATION OF THE QBD PARADIGM FOR
BIOLOGICS: LAYING THE FOUNDATION FOR PRODUCT AND PROCESS LIFECYCLE
MANAGEMENT
DIESES SCHRIFTSTUECK WURDE MASCHINELL ERZEUGT.
QUALITY BY DESIGN FOR BIOPHARMACEUTICAL DRUG PRODUCT DEVELOPMENT
/ JAMEEL, FEROZ
: 2015
ABSTRACT / INHALTSTEXT
THIS VOLUME EXPLORES THE APPLICATION OF QUALITY BY DESIGN (QBD) TO
BIOPHARMACEUTICAL DRUG PRODUCT DEVELOPMENT. TWENTY-EIGHT COMPREHENSIVE
CHAPTERS COVER DOSAGE FORMS, LIQUID AND LYOPHILIZED DRUG PRODUCTS. THE
INTRODUCTORY CHAPTERS OF THIS BOOK DEFINE KEY ELEMENTS OF QBD AND
EXAMINE HOW THESE ELEMENTS ARE INTEGRATED INTO DRUG PRODUCT DEVELOPMENT.
THESE CHAPTERS ALSO DISCUSS LESSONS LEARNED FROM THE FDA OFFICE OF
BIOTECHNOLOGY PRODUCTS PILOT PROGRAM. FOLLOWING CHAPTERS DEMONSTRATE HOW
QBD IS USED FOR FORMULATION DEVELOPMENT RANGING FROM SCREENING OF
FORMULATIONS TO DEVELOPABILITY ASSESSMENT TO DEVELOPMENT OF LYOPHILIZED
AND LIQUID FORMATS. THE NEXT FEW CHAPTERS STUDY THE USE OF SMALL-SCALE
AND SURROGATE MODELS AS WELL AS QBD APPLICATION TO DRUG PRODUCT
PROCESSES SUCH AS DRUG SUBSTANCE FREEZING AND THAWING, MIXING, STERILE
FILTRATION, FILLING, LYOPHILIZATION, INSPECTION AND SHIPPING AND
HANDLING. LATER CHAPTERS DESCRIBE MORE SPECIALIZED APPLICATIONS OF
QBD IN THE DRUG PRODUCT REALM. THIS INCLUDES THE USE OF QBD IN PRIMARY
CONTAINERS, DEVICES AND COMBINATION PRODUCT DEVELOPMENT. THE VOLUME ALSO
EXPLORES QBD APPLIED TO VACCINE DEVELOPMENT, AUTOMATION, MATHEMATICAL
MODELING AND MONITORING, AND CONTROLLING PROCESSES AND DEFINING CONTROL
STRATEGIES. IT CONCLUDES WITH A DISCUSSION ON THE APPLICATION OF QBD TO
DRUG PRODUCT TECHNOLOGY TRANSFER AS WELL AS OVERALL REGULATORY
CONSIDERATIONS AND LIFECYCLE MANAGEMENT. QUALITY BY DESIGN FOR
BIOPHARMACEUTICAL DRUG PRODUCT DEVELOPMENT IS AN AUTHORITATIVE RESOURCE
FOR SCIENTISTS AND RESEARCHERS INTERESTED IN EXPANDING THEIR KNOWLEDGE
ON QBD PRINCIPLES AND USES IN CREATING BETTER DRUGS
DIESES SCHRIFTSTUECK WURDE MASCHINELL ERZEUGT.
|
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| discipline | Biologie Medizin |
| doi_str_mv | 10.1007/978-1-4939-2316-8 |
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| indexdate | 2024-07-10T01:24:34Z |
| institution | BVB |
| isbn | 9781493923168 |
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| series2 | AAPS Advances in the Pharmaceutical Sciences Series |
| spelling | Quality by Design for Biopharmaceutical Drug Product Development Feroz Jameel, Susan Hershenson, Mansoor A. Khan, Sheryl Martin-Moe, ed. New York, NY [u.a.] Springer 2015 1 Online-Ressource (XX, 710 p. 214 illus., 163 illus. in color) txt rdacontent c rdamedia cr rdacarrier AAPS Advances in the Pharmaceutical Sciences Series 18 Medicine Toxicology Biomedicine Pharmacology/Toxicology Biomedicine general Medizin Jameel, Feroz Sonstige (DE-588)1022831585 oth Hershenson, Susan Sonstige oth Khan, Mansoor A. Sonstige oth Martin-Moe, Sheryl Sonstige oth Erscheint auch als Druckausgabe 978-1-4939-2315-1 AAPS Advances in the Pharmaceutical Sciences Series 18 (DE-604)BV041360401 18 https://doi.org/10.1007/978-1-4939-2316-8 Verlag Volltext Springer Fremddatenuebernahme application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=027978280&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis Springer Fremddatenuebernahme application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=027978280&sequence=000003&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA Abstract |
| spellingShingle | Quality by Design for Biopharmaceutical Drug Product Development AAPS Advances in the Pharmaceutical Sciences Series Medicine Toxicology Biomedicine Pharmacology/Toxicology Biomedicine general Medizin |
| title | Quality by Design for Biopharmaceutical Drug Product Development |
| title_auth | Quality by Design for Biopharmaceutical Drug Product Development |
| title_exact_search | Quality by Design for Biopharmaceutical Drug Product Development |
| title_full | Quality by Design for Biopharmaceutical Drug Product Development Feroz Jameel, Susan Hershenson, Mansoor A. Khan, Sheryl Martin-Moe, ed. |
| title_fullStr | Quality by Design for Biopharmaceutical Drug Product Development Feroz Jameel, Susan Hershenson, Mansoor A. Khan, Sheryl Martin-Moe, ed. |
| title_full_unstemmed | Quality by Design for Biopharmaceutical Drug Product Development Feroz Jameel, Susan Hershenson, Mansoor A. Khan, Sheryl Martin-Moe, ed. |
| title_short | Quality by Design for Biopharmaceutical Drug Product Development |
| title_sort | quality by design for biopharmaceutical drug product development |
| topic | Medicine Toxicology Biomedicine Pharmacology/Toxicology Biomedicine general Medizin |
| topic_facet | Medicine Toxicology Biomedicine Pharmacology/Toxicology Biomedicine general Medizin |
| url | https://doi.org/10.1007/978-1-4939-2316-8 http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=027978280&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=027978280&sequence=000003&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA |
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