MARC details
| 000 -LEADER |
| fixed length control field |
02705nam a2200385 i 4500 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
| control field |
20250919132117.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
| fixed length control field |
190523s2018 xxka g b 001 0 eng |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
| International Standard Book Number |
9780128027868 |
| Qualifying information |
hardback |
| Terms of availability |
RM625.50 |
| 035 ## - SYSTEM CONTROL NUMBER |
| System control number |
20505383 |
| 039 #9 - LEVEL OF BIBLIOGRAPHIC CONTROL AND CODING DETAIL [OBSOLETE] |
| Level of rules in bibliographic description |
201909231238 |
| Level of effort used to assign nonsubject heading access points |
jamain |
| Level of effort used to assign subject headings |
201909201229 |
| Level of effort used to assign classification |
jamain |
| Level of effort used to assign subject headings |
201909041613 |
| Level of effort used to assign classification |
ros |
| y |
05-23-2019 |
| z |
binar |
| 040 ## - CATALOGING SOURCE |
| Original cataloging agency |
Uk |
| Language of cataloging |
eng |
| Transcribing agency |
Uk UKM |
| Description conventions |
rda |
| 090 ## - LOCALLY ASSIGNED LC-TYPE CALL NUMBER (OCLC); LOCAL CALL NUMBER (RLIN) |
| Classification number (OCLC) (R) ; Classification number, CALL (RLIN) (NR) |
RS192.A263 |
| 090 ## - LOCALLY ASSIGNED LC-TYPE CALL NUMBER (OCLC); LOCAL CALL NUMBER (RLIN) |
| Classification number (OCLC) (R) ; Classification number, CALL (RLIN) (NR) |
RS192 |
| Local cutter number (OCLC) ; Book number/undivided call number, CALL (RLIN) |
.A263 |
| 245 00 - TITLE STATEMENT |
| Title |
Accelerated Predictive Stability (APS) : |
| Remainder of title |
fundamentals and pharmaceutical industry practices / |
| Statement of responsibility, etc. |
Fenghe Qiu, Garry Scrivens. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE |
| Place of production, publication, distribution, manufacture |
London : |
| Name of producer, publisher, distributor, manufacturer |
Academic Press, |
| Date of production, publication, distribution, manufacture, or copyright notice |
2018. |
| 264 #4 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE |
| Date of production, publication, distribution, manufacture, or copyright notice |
©2018. |
| 300 ## - PHYSICAL DESCRIPTION |
| Extent |
xxix, 481 pages : |
| Other physical details |
illustrations ; |
| Dimensions |
24 cm. |
| 336 ## - CONTENT TYPE |
| Content type term |
text |
| Content type code |
txt |
| Source |
rdacontent |
| 337 ## - MEDIA TYPE |
| Media type term |
unmediated |
| Media type code |
n |
| Source |
rdamedia |
| 338 ## - CARRIER TYPE |
| Carrier type term |
volume |
| Carrier type code |
nc |
| Source |
rdacarrier |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
| Bibliography, etc. note |
Includes bibliographical references and index. |
| 505 0# - FORMATTED CONTENTS NOTE |
| Formatted contents note |
Part I: General Chapters 1. Introduction 2. Regulatory Expectations and Industry Practice on Stability Testing 3. ASAP Theory and Fundamentals 4. Practical Considerations 5. Packaged Products 6. Data Evaluation and Statistical Methods 7. Assessing the Suitability of ASAP for the Sample 8. Application of ASAP in the Pharmaceutical Industry 9. The Value of ASAP in Early Clinical Drug Product Development 10. Embedding ASAP within Business 11. ASAP Regulatory Strategy and Acceptance and Feedback Part II: Industry Practices 12. ASAP Application in Product Development 13. Methods for the Analysis of Data from Accelerated Stability Studies 14. ASAP Application in Packaging Selection 15. ASAP Application in Post-approval Process Development 16. Using ASAP to Predict the Retest Period of an Unusually Unstable Drug Substance and to Select Prototype Formulations 17. Shelf Life Prediction and Packaging Selection of a Humidity-sensitive Product 18. ASAP Application in Suspension and Lyophilized Products 19. ASAP Application in Generic Products 20. Application of ASAP to Nicorette® Lozenges 21. Implementing an Accelerated Stability Assessment Program 22. ASAP: Case Studies from Early and Late Pharmaceutical Development Stages 23. Application of ASAP for Dissolution Predictions. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name entry element |
Pharmaceutical technology. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name entry element |
Pharmaceutical industry. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
| Personal name |
Qiu, Fenghe, |
| Relator term |
editor. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
| Personal name |
Scrivens, Garry, |
| Relator term |
editor. |
| 907 ## - LOCAL DATA ELEMENT G, LDG (RLIN) |
| a |
.b16726649 |
| b |
2019-11-12 |
| c |
2019-11-12 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
| Koha item type |
AM |
| Suppress in OPAC |
No |
| Call number prefix |
RS192.A263 |
| 914 ## - VTLS Number |
| VTLS Number |
vtls003648168 |
| 990 ## - EQUIVALENCES OR CROSS-REFERENCES [LOCAL, CANADA] |
| Link information for 9XX fields |
ros/jm |
| 991 ## - LOCAL NOTE (NAMA FAKULTI/INSTITUT/PUSAT) |
| a |
Fakulti Sains dan Teknologi |
| 998 ## - LOCAL CONTROL INFORMATION (RLIN) |
| Library |
PERPUSTAKAAN TUN SERI LANANG |
| Operator's initials, OID (RLIN) |
2019-10-05 |
| Cataloger's initials, CIN (RLIN) |
m |
| Material Type (Sierra) |
Printed Books |
| Language |
English |
| Country |
|
| -- |
0 |
| -- |
.b16726649 |