Methods for Stability Testing of Pharmaceuticals (Record no. 5993)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 03803nam a22004695i 4500 |
| 001 - CONTROL NUMBER | |
| control field | 978-1-4939-7686-7 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | DE-He213 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20260610083639.0 |
| 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 | 180525s2018 xxu| s |||| 0|eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781493976867 |
| -- | 978-1-4939-7686-7 |
| 024 7# - OTHER STANDARD IDENTIFIER | |
| Standard number or code | 10.1007/978-1-4939-7686-7 |
| Source of number or code | doi |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | RM300-666 |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MMG |
| Source | bicssc |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MED071000 |
| Source | bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MKG |
| Source | thema |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 615 |
| Edition information | 23 |
| 245 10 - TITLE STATEMENT | |
| Title | Methods for Stability Testing of Pharmaceuticals |
| Medium | [electronic resource] / |
| Statement of responsibility, etc. | edited by Sanjay Bajaj, Saranjit Singh. |
| 250 ## - EDITION STATEMENT | |
| Edition statement | 1st ed. 2018. |
| 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: Humana, |
| Date of production, publication, distribution, manufacture, or copyright notice | 2018. |
| 300 ## - online resource | |
| Extent | XIV, 358 p. 93 illus., 42 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 | Methods in Pharmacology and Toxicology, |
| International Standard Serial Number | 1940-6053 |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | Regulatory Guidelines on Stability Testing and Trending of Requirements -- The Stability Dossier: Common Deficiencies and Ways to Improve -- In Silico Drug Degradation Prediction -- Forced Degradation and Long-Term Stability Testing for Oral Drug Products: A Practical Approach -- A Model Approach for Developing Stability-Indicating Analytical Methods -- Protocols for Characterization of Degradation Products with Special Emphasis on Mutagenic Degradation Impurities -- Stability Studies: Facility and Systems -- User Requirements & Implementation of a Risk-Based, Compliant Stability Management System Based on the FDA New Guidance on DATA Integrity -- Stability Considerations in the Life Cycle of Generic Products -- Predictive Stability Testing Utilizing Accelerated Stability Assessment Program (ASAP) Studies -- Statistical Methods and Approaches to Avoid Stability Failures of Drug Product During Shelf-Life -- Estimation of Stability Based on Monitoring of Shipment and Storage -- Stability Testing Parameters and Issues for Nanotechnology-Based Drug Products -- Stability Testing Issues and Test Parameters for Herbal Medicinal Products -- Stability Testing Considerations for Biologicals and Biotechnology Products. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | This detailed volume collects numerous methods and protocols related to different aspects of stability programs that are followed in pharmaceutical development laboratories. Implementation of a successful stability program, vital in preventing product failures and recalls, requires critical and logical thinking that goes beyond the regular documented protocols and methods, so the experiences of the book’s internationally-based expert contributors fill the chapters with practical guidance. As a volume in the Methods in Pharmacology and Toxicology series, this book presents the kind of real-world advice that is essential for advancing laboratory research. Authoritative and thorough, Methods for Stability Testing of Pharmaceuticals serves as a valuable addition to the existing armamentarium of resources available to stability testing personnel in research and industry. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Pharmacology. |
| 650 14 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Pharmacology. |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Bajaj, Sanjay. |
| Relator term | editor. |
| Relationship | edt |
| -- | http://id.loc.gov/vocabulary/relators/edt |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Singh, Saranjit. |
| Relator term | editor. |
| Relationship | edt |
| -- | http://id.loc.gov/vocabulary/relators/edt |
| 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 | 9781493976850 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Printed edition: |
| International Standard Book Number | 9781493976874 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Printed edition: |
| International Standard Book Number | 9781493992584 |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE | |
| Uniform title | Methods in Pharmacology and Toxicology, |
| International Standard Serial Number | 1940-6053 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://doi.org/10.1007/978-1-4939-7686-7">https://doi.org/10.1007/978-1-4939-7686-7</a> |
| 912 ## - | |
| -- | ZDB-2-PRO |
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