MARC details
| 000 -LEADER |
|---|
| fixed length control field |
03656cam a22005054a 4500 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20250918235653.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
140716s2014 flua b 001 0 eng |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9781420086355 (hbk. : alk. paper) |
| Terms of availability |
RM684.38 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
1420086359 (hbk. : alk. paper) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9781420086362 (eBook) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
1420086367 (eBook) |
| 039 #9 - LEVEL OF BIBLIOGRAPHIC CONTROL AND CODING DETAIL [OBSOLETE] |
|---|
| Level of rules in bibliographic description |
201504280933 |
| Level of effort used to assign nonsubject heading access points |
zainol |
| y |
07-16-2014 |
| z |
fida |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
DNLM/DLC |
| Language of cataloging |
eng |
| Transcribing agency |
DLC |
| Modifying agency |
BTCTA |
| -- |
BAKER |
| -- |
YDXCP |
| -- |
NLM |
| -- |
OCLCO |
| -- |
TMY |
| -- |
IG# |
| -- |
OCLCF |
| -- |
CDX |
| -- |
IXA |
| -- |
OCLCO |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
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) |
QV771.G326 2014 9 |
| 090 ## - LOCALLY ASSIGNED LC-TYPE CALL NUMBER (OCLC); LOCAL CALL NUMBER (RLIN) |
|---|
| Classification number (OCLC) (R) ; Classification number, CALL (RLIN) (NR) |
QV771 |
| Local cutter number (OCLC) ; Book number/undivided call number, CALL (RLIN) |
.G326 2014 9 |
| 245 00 - TITLE STATEMENT |
|---|
| Title |
Generic drug product development : |
| Remainder of title |
solid oral dosage forms / |
| Statement of responsibility, etc. |
edited by Leon Shargel, Isadore Kanfer. |
| 250 ## - EDITION STATEMENT |
|---|
| Edition statement |
Second edition. |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
|---|
| Place of publication, distribution, etc. |
Boca Raton, FL : |
| Name of publisher, distributor, etc. |
CRC Press/Taylor & Francis Group, |
| Date of publication, distribution, etc. |
2014. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
xii, 385 p. : |
| Other physical details |
illustration ; |
| Dimensions |
25 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 |
| 490 1# - SERIES STATEMENT |
|---|
| Series statement |
Drugs and the pharmaceutical sciences ; |
| Volume/sequential designation |
129 |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
|---|
| Bibliography, etc. note |
Includes bibliographical references and index. |
| 505 0# - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
Active pharmaceutical ingredient / Edward M. Cohen, Steven Sutherland -- Analytical methods development and methods validation for solid oral dosage forms / Quanyin Gao, Dilip R. Sanvordeker -- Experimental formulation development / Isadore Kanfer ... [et al.] -- Scale-up, technology transfer, and process performance qualification / Salah U. Ahmed ... [et al.] -- Drug stability / Pranab K. Bhattacharyya -- Quality control and quality assurance / Loren Gelber -- Drug product performance, in vitro / Pradeep M. Sathe, John Duan, and Lawrence X. Yu -- ANDA regulatory approval process / Timothy W. Ames, Aaron Sigler -- Bioequivalence and drug product assessment, in vivo / Barbara M. Davit, Dale P, Conner -- Statistical considerations for establishing bioequivalence / Charles Bon, Sanford Bolton -- Outsourcing bioavailability and bioequivalence studies to contract research organizations / Patrick K. Noonan -- Post-approval changes and post-marketing surveillance / Lorien Armour, Leon Shargel -- United States Pharmacopeia-National Formulary : its history, organization, and role in harmonization / William Brown, Margareth R.C. Marques -- Legal and legislative hurdles to generic drug development, approval and marketing / Arthur T. Tsien. |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc. |
'This book collects in-depth discussions from more than 30 noted specialists on topics such as quality control, experimental formulations, pharmaceutical ingredients, conventional and modified-release products, and bioequivalence. It considers key elements in the formulation of generic drug products including the availability of raw materials and chemical purity. It contains new chapters on experimental formulation development, and the relationship between the FDA and the United States Pharmacopeia'--Provided by publisher. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Drugs, Generic |
| General subdivision |
standards. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Chemistry, Pharmaceutical |
| General subdivision |
standards. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Drug Approval. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Tablets. |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Generic drugs. |
| Source of heading or term |
fast |
| Authority record control number or standard number |
(OCoLC)fst00939969 |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Solid dosage forms. |
| Source of heading or term |
fast |
| Authority record control number or standard number |
(OCoLC)fst01125411 |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Shargel, Leon, |
| Dates associated with a name |
1941- |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Kanfer, Isadore. |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE |
|---|
| Uniform title |
Drugs and the pharmaceutical sciences ; |
| Volume/sequential designation |
v. 129. |
| 907 ## - LOCAL DATA ELEMENT G, LDG (RLIN) |
|---|
| a |
.b15952034 |
| b |
2019-11-12 |
| c |
2019-11-12 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Koha item type |
AM |
| Suppress in OPAC |
No |
| Call number prefix |
QV771.G326 2014 9 |
| 914 ## - VTLS Number |
|---|
| VTLS Number |
vtls003565101 |
| 990 ## - EQUIVALENCES OR CROSS-REFERENCES [LOCAL, CANADA] |
|---|
| Link information for 9XX fields |
zr |
| 991 ## - LOCAL NOTE (NAMA FAKULTI/INSTITUT/PUSAT) |
|---|
| a |
Fakulti Farmasi, KKL |
| 998 ## - LOCAL CONTROL INFORMATION (RLIN) |
|---|
| Library |
PERPUSTAKAAN DR ABDUL LATIFF |
| Operator's initials, OID (RLIN) |
2014-03-07 |
| Cataloger's initials, CIN (RLIN) |
m |
| Material Type (Sierra) |
Printed Books |
| Language |
English |
| Country |
|
| -- |
0 |
| -- |
.b15952034 |
