Introduction to Quality by Design (QbD) (Record no. 59048)
[ view plain ]
| 000 -LEADER | |
|---|---|
| fixed length control field | 03664nam a22005055i 4500 |
| 001 - CONTROL NUMBER | |
| control field | 978-981-99-8034-5 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | DE-He213 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20251030111812.0 |
| 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 | 240409s2024 si | s |||| 0|eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9789819980345 |
| -- | 978-981-99-8034-5 |
| 024 7# - OTHER STANDARD IDENTIFIER | |
| Standard number or code | 10.1007/978-981-99-8034-5 |
| Source of number or code | doi |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | RS400-431 |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | PSB |
| Source | bicssc |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | SCI013040 |
| Source | bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | PNB |
| Source | thema |
| 245 10 - TITLE STATEMENT | |
| Title | Introduction to Quality by Design (QbD) |
| Medium | [electronic resource] : |
| Remainder of title | From Theory to Practice / |
| Statement of responsibility, etc. | edited by N. K. Jain, Neha Bajwa. |
| 250 ## - EDITION STATEMENT | |
| Edition statement | 1st ed. 2024. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Place of production, publication, distribution, manufacture | Singapore : |
| Name of producer, publisher, distributor, manufacturer | Springer Nature Singapore : |
| -- | Imprint: Springer, |
| Date of production, publication, distribution, manufacture, or copyright notice | 2024. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | XXIV, 493 p. 102 illus., 96 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 |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | Chapter 1. Introduction to Quality by Design -- Chapter 2. Regulatory Aspects of Quality by Design (USFDA, PMDA, ICH, EMEA guidelines) -- Chapter 3. Criteria for selection of Design (PAT, CMA,CPA,CQA,RMEA) -- Chapter 4. Analytical Quality by Design -- Chapter 5. API Quality by Design -- Chapter 6. Quality by Design for formulation development -- Chapter 7. Quality by Design for oral formulations (tablets, spheroids) -- Chapter 8. Quality by Design for topical formulations -- Chapter 9. Quality by Design for parenteral formulations -- Chapter 10. Quality by Design approach for Novel Drug Delivery Systems -- Chapter 11. Quality by Design for herbal products/ formulations -- Chapter 12. Quality by Design in Quality Assurance -- Chapter 13. Quality by Design in pharmaceutical packaging -- Chapter 14. Quality by Design and Clinical Trials -- Chapter 15. Applications of Quality by design -- Chapter 16. Quality by Design and Marketing -- Chapter 17. Conclusions and Future perspective. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | This book offers a comprehensive exploration of the Quality by Design (QbD) methodology, guiding readers from theory to practical application with accessible examples. It equips readers with both foundational and advanced knowledge, emphasizing the critical parameters necessary for designing pharmaceutical products that meet the highest quality standards. The book goes beyond theory to demonstrate how to effectively implement QbD principles in various aspects of pharmaceutical research and development, including analytical methods, formulation, and packaging processes. Through a step-by-step approach, it prepares researchers in pharmaceutical sciences, as well as professionals in the pharmaceutical and healthcare industries (including suppliers), to successfully integrate QbD into their work. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 9 (RLIN) | 67843 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 650 14 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 9 (RLIN) | 67846 |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 9 (RLIN) | 69429 |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Jain, N. K. |
| Relator term | editor. |
| Relator code | edt |
| -- | http://id.loc.gov/vocabulary/relators/edt |
| 9 (RLIN) | 74951 |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Bajwa, Neha. |
| Relator term | editor. |
| Relator code | edt |
| -- | http://id.loc.gov/vocabulary/relators/edt |
| 9 (RLIN) | 74952 |
| 710 2# - ADDED ENTRY--CORPORATE NAME | |
| Corporate name or jurisdiction name as entry element | SpringerLink (Online service) |
| 773 0# - HOST ITEM ENTRY | |
| Title | Springer Nature eBook |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Printed edition: |
| International Standard Book Number | 9789819980338 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Printed edition: |
| International Standard Book Number | 9789819980352 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Printed edition: |
| International Standard Book Number | 9789819980369 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://doi.org/10.1007/978-981-99-8034-5">https://doi.org/10.1007/978-981-99-8034-5</a> |
| 912 ## - | |
| -- | ZDB-2-CMS |
| 912 ## - | |
| -- | ZDB-2-SXC |
No items available.