| 000 -LEADER |
|---|
| fixed length control field |
03117cam a22004334a 4500 |
| 001 - CONTROL NUMBER |
|---|
| control field |
17694826 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20160705123948.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
130411s2014 flua b 001 0 eng |
| 010 ## - LIBRARY OF CONGRESS CONTROL NUMBER |
|---|
| LC control number |
2013014696 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9781420086355 (hbk. : alk. paper) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9781420086362 (eBook) |
| 035 ## - SYSTEM CONTROL NUMBER |
|---|
| System control number |
(DNLM)101606012 |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
DNLM/DLC |
| Transcribing agency |
DLC |
| Modifying agency |
DLC |
| 042 ## - AUTHENTICATION CODE |
|---|
| Authentication code |
pcc |
| 050 00 - LIBRARY OF CONGRESS CALL NUMBER |
|---|
| Classification number |
RS55.2 |
| Item number |
.G455 2014 |
| 060 10 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER |
|---|
| Classification number |
W1 |
| Item number |
DR893B v.129 2014 |
| 060 10 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER |
|---|
| Classification number |
QV 771 |
| 082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Classification number |
615.19 SHA-L |
| Edition number |
23 |
| 100 ## - MAIN ENTRY--PERSONAL NAME |
|---|
| Personal name |
edited by Shargel, Leon |
| 245 00 - TITLE STATEMENT |
|---|
| Title |
Generic drug product development : |
| Remainder of title |
solid oral dosage forms / |
| Statement of responsibility, etc. |
edited by Leon Shargel and Isadore Kanfer |
| 250 ## - EDITION STATEMENT |
|---|
| Edition statement |
2nd |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
|---|
| Place of publication, distribution, etc. |
Boca Raton |
| Name of publisher, distributor, etc. |
CRC Press |
| Date of publication, distribution, etc. |
2014 |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
385 p. |
| Dimensions |
25 cm. |
| 365 ## - TRADE PRICE |
|---|
| Price type code |
GBP |
| Price amount |
134.00. |
| 490 0# - SERIES STATEMENT |
|---|
| Series statement |
Drugs and the pharmaceutical sciences ; |
| Volume/sequential designation |
129 |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
|---|
| Bibliography, etc |
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 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Generic drugs. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Solid dosage forms. |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drugs, Generic |
| General subdivision |
standards. |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Chemistry, Pharmaceutical |
| General subdivision |
standards. |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drug Approval. |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Tablets. |
| 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. |
| 906 ## - LOCAL DATA ELEMENT F, LDF (RLIN) |
|---|
| a |
7 |
| b |
cbc |
| c |
orignew |
| d |
1 |
| e |
ecip |
| f |
20 |
| g |
y-gencatlg |
| 955 ## - COPY-LEVEL INFORMATION (RLIN) |
|---|
| Classification number, CCAL (RLIN) |
xn03 2013-12-03 1 copy rec'd., to CIP ver. |
| 952 ## - LOCATION AND ITEM INFORMATION (KOHA) |
|---|
| Withdrawn status |
|
