MARC details
| 000 -LEADER |
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| fixed length control field |
03738nam a22004575i 4500 |
| 001 - CONTROL NUMBER |
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| control field |
978-1-4939-1252-0 |
| 003 - CONTROL NUMBER IDENTIFIER |
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| control field |
DE-He213 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
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| control field |
20160405110535.0 |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION |
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| fixed length control field |
cr nn 008mamaa |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
140905s2014 xxu| s |||| 0|eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| International Standard Book Number |
9781493912520 |
| -- |
978-1-4939-1252-0 |
| 024 7# - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
10.1007/978-1-4939-1252-0 |
| Source of number or code |
doi |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER |
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| Classification number |
RS380 |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER |
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| Classification number |
RS190-210 |
| 072 #7 - SUBJECT CATEGORY CODE |
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| Subject category code |
TDCW |
| Source |
bicssc |
| 072 #7 - SUBJECT CATEGORY CODE |
|---|
| Subject category code |
MED072000 |
| Source |
bisacsh |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Classification number |
615.19 |
| Edition number |
23 |
| 245 10 - TITLE STATEMENT |
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| Title |
FDA Bioequivalence Standards |
| Medium |
[electronic resource] / |
| Statement of responsibility, etc |
edited by Lawrence X. Yu, Bing V. Li. |
| 264 #1 - |
|---|
| -- |
New York, NY : |
| -- |
Springer New York : |
| -- |
Imprint: Springer, |
| -- |
2014. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
XIII, 465 p. 58 illus., 26 illus. in color. |
| Other physical details |
online resource. |
| 336 ## - |
|---|
| -- |
text |
| -- |
txt |
| -- |
rdacontent |
| 337 ## - |
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| -- |
computer |
| -- |
c |
| -- |
rdamedia |
| 338 ## - |
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| -- |
online resource |
| -- |
cr |
| -- |
rdacarrier |
| 347 ## - |
|---|
| -- |
text file |
| -- |
PDF |
| -- |
rda |
| 490 1# - SERIES STATEMENT |
|---|
| Series statement |
AAPS Advances in the Pharmaceutical Sciences Series, |
| International Standard Serial Number |
2210-7371 ; |
| Volume number/sequential designation |
13 |
| 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. |
| 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 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Medicine. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Pharmaceutical technology. |
| 650 14 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Biomedicine. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Pharmaceutical Sciences/Technology. |
| 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 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
|---|
| Display text |
Printed edition: |
| International Standard Book Number |
9781493912513 |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE |
|---|
| Uniform title |
AAPS Advances in the Pharmaceutical Sciences Series, |
| -- |
2210-7371 ; |
| Volume number/sequential designation |
13 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Uniform Resource Identifier |
<a href="http://dx.doi.org/10.1007/978-1-4939-1252-0">http://dx.doi.org/10.1007/978-1-4939-1252-0</a> |
| 912 ## - |
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| -- |
ZDB-2-SBL |
