MARC details
| 000 -LEADER |
|---|
| fixed length control field |
03404nam a22003615a 4500 |
| 001 - CONTROL NUMBER |
|---|
| control field |
11007392 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20160217143648.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
141103t2014 nyua frb 001 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9781493912513 |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
EG-ScBUE |
| Language of cataloging |
eng |
| Transcribing agency |
EG-ScBUE |
| Modifying agency |
EG-ScBUE |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Classification number |
615.1 |
| Edition number |
22 |
| Item number |
FDA |
| 245 10 - TITLE STATEMENT |
|---|
| Title |
FDA Bioequivalence Standards / |
| Statement of responsibility, etc |
edited by Lawrence X. Yu, Bing V. Li. |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
|---|
| Place of publication, distribution, etc |
New York : |
| Name of publisher, distributor, etc |
AAPS Press : |
| -- |
Springer, |
| Date of publication, distribution, etc |
c.2014. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
xiii, 465 p. : |
| Other physical details |
ill. ; |
| Dimensions |
24 cm. |
| 490 0# - Series Statement |
|---|
| Series statement |
AAPS Advances in the Pharmaceutical Sciences Series, |
| International Standard Serial Number |
2210-7371 ; |
| Volume/sequential designation |
13 |
| 500 ## - GENERAL NOTE |
|---|
| General note |
Index : p. 463-465. |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
|---|
| Bibliography, etc |
Includes bibliographical references. |
| 505 0# - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
1 Bioequivalence History -- 2 Fundamentals of Bioequivalence -- 3 Basic Statistical Considerations -- 4 The Effects of Food on Drug Bioavailability and Bioequivalence -- 5 Bio waiver and Biopharmaceutics Classification System -- 6 Bioequivalence of Highly Variable Drugs -- 7 Partial Area under the Curve: An Additional Pharmacokinetic Metric for Bioavailability and Bioequivalence Assessments -- 8 Bioequivalence for Narrow Therapeutic Index Drugs -- 9 Pharmacodynamic Endpoint-based Bioequivalence Studies -- 10 Clinical Endpoint Bioequivalence Study -- 11 Bioequivalence for Liposomal Drug Products -- 12 Bioequivalence for Drug Products Acting Locally within Gastrointestinal Tract -- 13 Bioequivalence for Topical Drug Products -- 14 Bioequivalence for Orally Inhaled and Nasal Drug Products -- 15 Bioequivalence: Modeling and Simulation -- 16 Bioanalysis. |
| 506 ## - RESTRICTIONS ON ACCESS NOTE |
|---|
| Terms governing access |
License restrictions may limit access. |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc |
This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation, and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products, and nasal and inhalation products. FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies, and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards. |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drugs |
| Source of heading or term |
BUEsh |
| General subdivision |
Therapeutic equivalency. |
| 9 (RLIN) |
39375 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drugs |
| General subdivision |
Standards |
| Source of heading or term |
BUEsh |
| Geographic subdivision |
United States |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
|---|
| Source of heading or term |
BUEsh |
| 653 ## - INDEX TERM--UNCONTROLLED |
|---|
| Resource For college |
Pharmacy |
| Arrived date list |
February2016 |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Yu, Lawrence X., |
| Relator term |
editor. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Li, Bing V., |
| Relator term |
editor. |
| 710 2# - ADDED ENTRY--CORPORATE NAME |
|---|
| Corporate name or jurisdiction name as entry element |
SpringerLink (Online service) |
| 773 0# - HOST ITEM ENTRY |
|---|
| Title |
Springer eBooks |
| 773 #0 - HOST ITEM ENTRY |
|---|
| Title |
SpringerLINK ebooks - Biomedical and Life Sciences (2014) |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
|---|
| Display text |
Printed edition: |
| International Standard Book Number |
9781493912513 |
| 910 ## - USER-OPTION DATA (OCLC) |
|---|
| User-option data |
Vendor-generated brief record |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Source of classification or shelving scheme |
Dewey Decimal Classification |
| 952 ## - LOCATION AND ITEM INFORMATION (KOHA) |
|---|
| -- |
2016-02-17 |