Sterile product development (Record no. 3089)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 00832nam a2200229Ia 4500 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20190503111155.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 180803s9999 xx 000 0 und d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 978-1-4614-7977-2 |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | AIKTC-KRRC |
| Transcribing agency | AIKTC-KRRC |
| 041 ## - LANGUAGE CODE | |
| Language code of text/sound track or separate title | ENG |
| 082 ## - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 615.19 |
| Item number | KOL/SHA |
| Edition number | DDC23 |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Kolhe, Parag |
| 9 (RLIN) | 4289 |
| 245 #0 - TITLE STATEMENT | |
| Title | Sterile product development |
| 246 ## - VARYING FORM OF TITLE | |
| Title proper/short title | Formulation, process, quality and regulatory considerations |
| 250 ## - EDITION STATEMENT | |
| Edition statement | 1st |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Place of publication, distribution, etc. | Dordrecht |
| Name of publisher, distributor, etc. | Springer |
| Date of publication, distribution, etc. | 2013 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 585 Pages |
| Other physical details | Web Format |
| 440 ## - SERIES STATEMENT/ADDED ENTRY--TITLE | |
| Title | AAPS advances in the pharmaceutical sciences series 6 |
| 9 (RLIN) | 4290 |
| 490 ## - SERIES STATEMENT | |
| Series statement | Crommelin, Daan J. A. |
| 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:<br/><br/>• Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines<br/><br/>• 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<br/><br/>• 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<br/><br/>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 | |
| 9 (RLIN) | 5008 |
| Topical term or geographic name entry element | PHARMACEUTICAL CHEMISTRY |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Shah, Mrinal |
| 9 (RLIN) | 4292 |
| 856 ## - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://ndl.iitkgp.ac.in/result?q={%22t%22:%22search%22,%22k%22:%22pharmaceutical%20chemistry%22,%22s%22:[%22DDC=\%22600%3A%3ATechnology\%22%22],%22b%22:{%22filters%22:[]}}">https://ndl.iitkgp.ac.in/result?q={%22t%22:%22search%22,%22k%22:%22pharmaceutical%20chemistry%22,%22s%22:[%22DDC=\%22600%3A%3ATechnology\%22%22],%22b%22:{%22filters%22:[]}}</a> |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Koha item type | Books |
| Source of classification or shelving scheme | Dewey Decimal Classification |
| Withdrawn status | Lost status | Source of classification or shelving scheme | Damaged status | Use restrictions | Not for loan | Collection code | Home library | Current library | Shelving location | Date acquired | Source of acquisition | Cost, normal purchase price | Total Checkouts | Full call number | Barcode | Date last seen | Cost, replacement price | Koha item type |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dewey Decimal Classification | Restricted Access | Not For Loan | Reference | School of Pharmacy | School of Pharmacy | Reference Section | 28/01/2016 | Medico's Book Aid | 8875.66 | 615.19 KOL/SHA | B2981 | 25/06/2025 | 11834.21 | Books |