Biosimilarity : (Record no. 71109)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 02513nam a2200517Ii 4500 |
| 001 - CONTROL NUMBER | |
| control field | 9781315368344 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20220531132340.0 |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS | |
| fixed length control field | m o d |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 181112t20182017fluab ob 001 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781315368344 |
| -- | (e-book : PDF) |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (OCoLC)1057341765 |
| 040 ## - Cataloging Source | |
| -- | FlBoTFG |
| -- | FlBoTFG |
| -- | rda |
| 041 1# - | |
| -- | eng |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | RS67.U6 |
| Item number | N539 2018 |
| 072 #7 - | |
| -- | MED |
| -- | 009000 |
| -- | bisacsh |
| 072 #7 - | |
| -- | MED |
| -- | 071000 |
| -- | bisacsh |
| 072 #7 - | |
| -- | TDCW |
| -- | bicscc |
| 082 04 - | |
| -- | 615.10973 |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Niazi, Sarfaraz K., |
| Relator term | author. |
| 245 10 - TITLE STATEMENT | |
| Title | Biosimilarity : |
| Remainder of title | The FDA Perspective / |
| Statement of responsibility, etc. | by Sarfaraz K. Niazi. |
| 250 ## - EDITION STATEMENT | |
| Edition statement | First edition. |
| 264 #1 - | |
| -- | Boca Raton, FL : |
| -- | CRC Press, |
| -- | [2018]. |
| 264 #4 - | |
| -- | ©2017. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 1 online resource (436 pages) : |
| Other physical details | 79 illustrations, text file, PDF |
| 336 ## - | |
| -- | text |
| -- | rdacontent |
| 337 ## - | |
| -- | computer |
| -- | rdamedia |
| 338 ## - | |
| -- | online resource |
| -- | rdacarrier |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE | |
| Bibliography, etc | Includes bibliographical references and index. |
| 505 00 - | |
| -- | Current Status of Biosimilar Biological Products. The FDA Position. Biosimilarity Tetrahedron. Analytical and Functionality Similarity. Non-clinical Assessment. Clinical Pharmacology Assessment. Clinical Studies. Interchangeability Status. Comprehensive Presentation |
| 520 3# - | |
| -- | The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place. However, these guidelines do not apply to the thinking of the FDA in approving these products. The FDA is quite different from other regulatory agencies. With the US providing more than 50% of the worldwide market for these products, every serious manufacturer of biosimilar biological drugs should be targeting US approval of their products. Thus, this book is strictly on FDA approval strategy. |
| 530 ## - | |
| -- | Also available in print format. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Drugs |
| General subdivision | Generic substitution. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmaceutical biotechnology |
| Geographic subdivision | United States. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmaceutical biotechnology. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Biosimilar Pharmaceuticals. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Drug Approval. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Government Regulation. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | United States Government Agencies. |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | MEDICAL / Pharmacology. |
| Source of heading or term | bisacsh |
| 655 #0 - | |
| -- | Electronic books. |
| 710 2# - ADDED ENTRY--CORPORATE NAME | |
| Corporate name or jurisdiction name as entry element | Taylor and Francis. |
| 776 08 - | |
| -- | Print version: |
| -- | 9781498750394 |
| 856 40 - | |
| -- | https://www.taylorfrancis.com/books/9781315368344 |
| -- | Click here to view. |
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