Quality assessment of biosimilars relative to innovator products using instrumental methods of analysis / (Record no. 56623)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 03315cam a2200349 a 4500 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | EG-GiCUC |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20250223031513.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 160524s2015 ua d f m 000 0 eng d |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | EG-GiCUC |
| Language of cataloging | eng |
| Transcribing agency | EG-GiCUC |
| 041 0# - LANGUAGE CODE | |
| Language code of text/sound track or separate title | eng |
| 049 ## - LOCAL HOLDINGS (OCLC) | |
| Holding library | Deposite |
| 097 ## - Thesis Degree | |
| Thesis Level | M.Sc |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) | |
| Classification number | Cai01.08.03.M.Sc.2015.Em.Q |
| 100 0# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Eman Lotfi Shaltout |
| 245 10 - TITLE STATEMENT | |
| Title | Quality assessment of biosimilars relative to innovator products using instrumental methods of analysis / |
| Statement of responsibility, etc. | Eman Lotfi Shaltout ; Supervised Maissa Yacoub Salem , Medhat Ahmed Alghobashy , Faten Abdelaziz Fathalla |
| 246 15 - VARYING FORM OF TITLE | |
| Title proper/short title | تحديد جودة المنتجات الحيوية المماثلة نسبة إلى منتجات المبتكر باستخدام طرق التحليل الآلى |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Place of publication, distribution, etc. | Cairo : |
| Name of publisher, distributor, etc. | Eman Lotfi Shaltout , |
| Date of publication, distribution, etc. | 2015 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 116 P. : |
| Other physical details | charts ; |
| Dimensions | 25cm |
| 502 ## - DISSERTATION NOTE | |
| Dissertation note | Thesis (M.Sc.) - Cairo University - Faculty of Pharmacy - Department of Analytical Chemistry |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Biosimilars are biotechnology-derived products that are biologically similar but not identical to an authorized innovator product. Extensive comparability study for the biosimilar product and the reference product is commonly required. An orthogonal testing protocol was developed and validated to assess the quality of Filgrastim biosimilars. Initial screening was carried out using gel electrophoresis and peptide mapping to confirm the product primary structure. CIEF was used to detect the charged impurities. It was optimized using neutrally coated capillaries over a wide-range pH gradient (pH 3.0{u2013}10.0). Impurities above the acceptable limits were detected in both biosimilar products. CIEF also revealed heterogeneity in the active ingredient that has not been investigated by the manufacturers. RP-HPLC was employed for the determination of Filgrastim in the presence of its oxidative degradation products. The assay was accurate and precise over a linear concentration range of 9.38{u2013}300.00 æg/mL. SE-HPLC was carried out over a molecular weight range of 5{u2013}150 kDa to reveal impurities with high molecular weight. The assay was found accurate and precise over a linear concentration range of 20.00{u2013}400.00 æg/mL.Filgrastim oxidized forms and higher molecular weight impurities were detected in the biosimilars. Immunoassay was carried out to determine the protein content and to predict the tertiary structural confirmation. Antigen- antibody reaction was very low in the two biosimilars. Inability to bind could be due to some degree of protein deformation. Finally; spectrophotometric techniques were used to determine the total protein content. Results confirmed the need for in-house validated orthogonal testing protocols to be developed by local regulatory authorities. This should prevent access of substandard biosimilars to price-sensitive markets |
| 530 ## - ADDITIONAL PHYSICAL FORM AVAILABLE NOTE | |
| Additional physical form available note | Issued also as CD |
| 653 #4 - INDEX TERM--UNCONTROLLED | |
| Uncontrolled term | Biosimilars relative |
| 653 #4 - INDEX TERM--UNCONTROLLED | |
| Uncontrolled term | Innovator products |
| 653 #4 - INDEX TERM--UNCONTROLLED | |
| Uncontrolled term | Instrumental methods of analysis |
| 700 0# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Faten Abdelaziz Fathalla , |
| Relator term | |
| 700 0# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Maissa Yacoub Salem, |
| Relator term | |
| 700 0# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Medhat Ahmed Alghobashy , |
| Relator term | |
| 856 ## - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="http://172.23.153.220/th.pdf">http://172.23.153.220/th.pdf</a> |
| 905 ## - LOCAL DATA ELEMENT E, LDE (RLIN) | |
| Cataloger | Aml |
| Reviser | Cataloger |
| 905 ## - LOCAL DATA ELEMENT E, LDE (RLIN) | |
| Cataloger | Nazla |
| Reviser | Revisor |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Dewey Decimal Classification |
| Koha item type | Thesis |
| Source of classification or shelving scheme | Not for loan | Home library | Current library | Date acquired | Full call number | Barcode | Date last seen | Koha item type | Copy number |
|---|---|---|---|---|---|---|---|---|---|
| Dewey Decimal Classification | المكتبة المركزبة الجديدة - جامعة القاهرة | قاعة الرسائل الجامعية - الدور الاول | 11.02.2024 | Cai01.08.03.M.Sc.2015.Em.Q | 01010110069060000 | 22.09.2023 | Thesis | ||
| Dewey Decimal Classification | المكتبة المركزبة الجديدة - جامعة القاهرة | مخـــزن الرســائل الجـــامعية - البدروم | 11.02.2024 | Cai01.08.03.M.Sc.2015.Em.Q | 01020110069060000 | 22.09.2023 | CD - Rom | 69060.CD |