Biosimilarity : (Record no. 90696)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 01705nam a22002177a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 230307b2019 |||||||| |||| 00| 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781498750394 |
| 082 ## - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 615.1097 NIA-S |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Niazi, Sarfaraz K. |
| 245 ## - TITLE STATEMENT | |
| Title | Biosimilarity : |
| Remainder of title | the FDA perspective / |
| Statement of responsibility, etc. | Sarfaraz K. Niazi |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) | |
| Place of publication, distribution, etc. | Boca Raton |
| Name of publisher, distributor, etc. | CRC Press |
| Date of publication, distribution, etc. | 2019 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 397 p. |
| 365 ## - TRADE PRICE | |
| Price type code | GBP |
| Price amount | 150.00. |
| Unit of pricing | 150.00 |
| 500 ## - GENERAL NOTE | |
| General note | Summary:<br/><br/>The focus of this book is on how the U.S. FDA will approve biosimilar drugs, as learned from recent approvals by the FDA. Understanding the limitations of the statutory limits and non-inferiority testing are presented as tools to obviate patient trials and minimize testing of immunogenicity. An in-depth scientific, mathematical and statistical view of the tools required to establish biosimilarity of biological drugs of different complexity -- a must for every developer of biosimilars.<br/><br/>Features:<br/><br/>First comprehensive analysis based on new guidelines and approval packages of several biosimilars<br/><br/>Presents the first approach to challenge FDA in reducing or eliminating any testing in patients.<br/><br/>Provides a comprehensive understanding of the U.S. statutory requirements vis-a-vis the regulatory guidelines<br/><br/>Provides model CQA and Analytical Similarity testing protocols for cytokines and monoclonal antibodies<br/><br/>Allow creation of a fast-to-market pathway to develop biosimilars. |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | United States |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmaceutical biotechnology |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Drugs--Generic substitution |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Drug approval |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | United States. Food and Drug Administration |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Generic drugs |
| 952 ## - LOCATION AND ITEM INFORMATION (KOHA) | |
| Withdrawn status | |
| 365 ## - TRADE PRICE | |
| -- | 27.05.2023 |
| -- | 17600 |
| -- | 41917 |
| -- | 23.05.2023 |
| -- | Great Britain Pound |
| Lost status | Source of classification or shelving scheme | Damaged status | Not for loan | Collection code | Home library | Current library | Shelving location | Date acquired | Full call number | Barcode | Date last seen | Price effective from | Koha item type |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dewey Decimal Classification | 610 | BITS Pilani Hyderabad | BITS Pilani Hyderabad | Text & Reference Section (Student cannot borrow these books) | 07/03/2023 | 615.1097 NIA-S | 47092 | 26/07/2023 | 07/03/2023 | Text Book |
