| 000 -LEADER |
|---|
| fixed length control field |
02278cam a22003614a 4500 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20150712005536.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
050110s2005 nyua b 001 0 eng |
| 010 ## - LIBRARY OF CONGRESS CONTROL NUMBER |
|---|
| LC control number |
2005040476 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
0824754603 |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
DLC |
| Transcribing agency |
DLC |
| Modifying agency |
UKM |
| -- |
C\P |
| -- |
SDB |
| 042 ## - AUTHENTICATION CODE |
|---|
| Authentication code |
pcc |
| 050 00 - LIBRARY OF CONGRESS CALL NUMBER |
|---|
| Classification number |
RS55.2 |
| Item number |
.G455 2005 |
| 060 ## - NATIONAL LIBRARY OF MEDICINE CALL NUMBER |
|---|
| Item number |
SG |
| 082 ## - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Classification number |
615.19 |
| 084 ## - OTHER CLASSIFICATION NUMBER |
|---|
| Classification number |
615.19 |
| Item number |
SG |
| 001 - CONTROL NUMBER |
|---|
| control field |
0000024783 |
| 003 - CONTROL NUMBER IDENTIFIER |
|---|
| control field |
0000 |
| 100 1# - MAIN ENTRY--PERSONAL NAME |
|---|
| Personal name |
Shargel ,Leon . |
| 245 10 - TITLE STATEMENT |
|---|
| Title |
Generic drug product development |
| Medium |
[[Book] :] |
| Remainder of title |
solid oral dosage forms / |
| Statement of responsibility, etc. |
Leon Shargel, Isadore Kanfer. |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
|---|
| Place of publication, distribution, etc. |
New York : |
| Name of publisher, distributor, etc. |
Marcel Dekker, |
| Date of publication, distribution, etc. |
2005. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
xi, 381 p. : |
| Other physical details |
ill. ; |
| Dimensions |
24 cm. |
| 440 #0 - SERIES STATEMENT/ADDED ENTRY--TITLE |
|---|
| Title |
Drugs and the pharmaceutical sciences ; |
| Volume/sequential designation |
v. 143. |
| 500 ## - GENERAL NOTE |
|---|
| General note |
includes index. |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
|---|
| Bibliography, etc |
Includes bibliographical references and index. |
| 505 00 - FORMATTED CONTENTS NOTE |
|---|
| Title |
Introduction to generic drug product development /. |
| Statement of responsibility |
Leon Shargel, Izzy Kanfer -- |
| Title |
Active pharmaceutical ingredients /. |
| Statement of responsibility |
Edward M. Cohen, Lih-Yang Lin -- |
| Title |
Analytical methods development and methods validation for solid oral dosage forms /. |
| Statement of responsibility |
Quanyin Gao, Robert Vita, Dilip R. Sanvordeker -- |
| Title |
Experimental formulation development /. |
| Statement of responsibility |
Izzy Kanfer, Peter Persicaner, Roderick B. Walker -- |
| Title |
Scale-up, process validation, and technology transfer /. |
| Statement of responsibility |
Salah C. Ahmed, Venkatesh Naini, Dilip Wadgaonkar -- |
| Title |
Drug stability /. |
| Statement of responsibility |
Pranab K. Bhattacharyya -- |
| Title |
Quality control and quality assurance /. |
| Statement of responsibility |
Loren Gelber, Joan Janulis -- |
| Title |
Drug product performance, in vitro /. |
| Statement of responsibility |
Pradeep M. Sathe ... [et al.] -- |
| Title |
ANDA regulatory approval process /. |
| Statement of responsibility |
Timothy W. Ames ... [et al.] -- |
| Title |
Bioequivalence and drug product assessment, in vivo /. |
| Statement of responsibility |
Dale P. Conner, Barbara M. Davit -- |
| Title |
Statistical considerations for establishing bioequivalence /. |
| Statement of responsibility |
Sanford Bolton -- |
| Title |
Scale-up, post-approval changes, and post-marketing surveillance /. |
| Statement of responsibility |
Sadie M. Ciganek ... [et al.] -- |
| Title |
Outsourcing bioavailability and bioequivalence studies to contract research organizations /. |
| Statement of responsibility |
Patrick K. Noonan -- |
| Title |
Legal and legislative hurdles to generic drug development, approval, and marketing /. |
| Statement of responsibility |
Arthur Y. Tsien. |
| 521 ## - TARGET AUDIENCE NOTE |
|---|
| Target audience note |
All age. |
| 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. |
| 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. |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Koha item type |
Books |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Koha item type |
Books |
