Sterile Product Development (Record no. 44977)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 04643nam a22004937a 4500 |
| 001 - CONTROL NUMBER | |
| control field | sulb-eb0022885 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | BD-SySUS |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20160413122324.0 |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr nn 008mamaa |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 131012s2013 xxu| s |||| 0|eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781461479789 |
| -- | 978-1-4614-7978-9 |
| 024 7# - OTHER STANDARD IDENTIFIER | |
| Standard number or code | 10.1007/978-1-4614-7978-9 |
| Source of number or code | doi |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | RS380 |
| Classification number | RS190-210 |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | TDCW |
| Source | bicssc |
| Subject category code | MED072000 |
| Source | bisacsh |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 615.19 |
| Edition number | 23 |
| 245 10 - TITLE STATEMENT | |
| Title | Sterile Product Development |
| Medium | [electronic resource] : |
| Remainder of title | Formulation, Process, Quality and Regulatory Considerations / |
| Statement of responsibility, etc. | edited by Parag Kolhe, Mrinal Shah, Nitin Rathore. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Place of production, publication, distribution, manufacture | New York, NY : |
| Name of producer, publisher, distributor, manufacturer | Springer New York : |
| -- | Imprint: Springer, |
| Date of production, publication, distribution, manufacture, or copyright notice | 2013. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | XVI, 585 p. 89 illus., 67 illus. in color. |
| Other physical details | online resource. |
| 336 ## - CONTENT TYPE | |
| Content type term | text |
| Content type code | txt |
| Source | rdacontent |
| 337 ## - MEDIA TYPE | |
| Media type term | computer |
| Media type code | c |
| Source | rdamedia |
| 338 ## - CARRIER TYPE | |
| Carrier type term | online resource |
| Carrier type code | cr |
| Source | rdacarrier |
| 347 ## - DIGITAL FILE CHARACTERISTICS | |
| File type | text file |
| Encoding format | |
| Source | rda |
| 490 1# - SERIES STATEMENT | |
| Series statement | AAPS Advances in the Pharmaceutical Sciences Series, |
| International Standard Serial Number | 2210-7371 ; |
| Volume/sequential designation | 6 |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | Basic Principles of Sterile Product Formulation Development -- Molecule and Manufacturability Assessment Leading to Robust Commercial Formulation for Therapeutic Proteins -- Polymer and Lipid Based Systems for Parenteral Drug Delivery -- Formulation Approaches and Strategies for PEGylated Biotherapeutics -- Nasal Delivery -- Formulation Approaches and Strategies for Vaccines and Adjuvants -- Challenges in Freeze-Thaw Processing of Bulk Protein Solutions -- Best Practices for Technology Transfer of Sterile Products: Case Studies -- Transfer Across Barrier Systems: A New Source of Simplification in Aseptic Fill and Finish Operations -- Challenges and Innovation in Aseptic Filling: Case Study with the Closed Vial Technology -- Contemporary Approaches to Development and Manufacturing of Lyophilized Parenterals -- Advances in Container Closure Integrity Testing -- Pen and Autoinjector Drug Delivery Devices -- Particulate Matter in Sterile Parenteral Products -- Appearance Evaluation of Parenteral Pharmaceutical Products -- Sterile Filtration Principles, Best Practices and New Developments -- Intravenous Admixture Compatibility for Sterile Products: Challenges and Regulatory Guidance -- Basics of Sterilization Methods -- Avoiding Common Errors during Viable Microbial Contamination Investigations -- Validation of Rapid Microbiology Methods (RMMs) -- Validation of Moist and Dry Heat Sterilization. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | 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 commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Medicine. |
| Topical term or geographic name as entry element | Pharmaceutical technology. |
| Topical term or geographic name as entry element | Biomedicine. |
| Topical term or geographic name as entry element | Pharmaceutical Sciences/Technology. |
| Topical term or geographic name as entry element | Biomedicine general. |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Kolhe, Parag. |
| Relator term | editor. |
| Personal name | Shah, Mrinal. |
| Relator term | editor. |
| Personal name | Rathore, Nitin. |
| Relator term | editor. |
| 710 2# - ADDED ENTRY--CORPORATE NAME | |
| Corporate name or jurisdiction name as entry element | SpringerLink (Online service) |
| 773 0# - HOST ITEM ENTRY | |
| Title | Springer eBooks |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Printed edition: |
| International Standard Book Number | 9781461479772 |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE | |
| Uniform title | AAPS Advances in the Pharmaceutical Sciences Series, |
| International Standard Serial Number | 2210-7371 ; |
| Volume number/sequential designation | 6 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="http://dx.doi.org/10.1007/978-1-4614-7978-9">http://dx.doi.org/10.1007/978-1-4614-7978-9</a> |
| 912 ## - | |
| -- | ZDB-2-SBL |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | |
| Koha item type | |
No items available.