| Type of Material: | Thesis |
| Title: | Comparative Analytical Characterization of Selected Biosimilar Formulations Available in India |
| Researcher: | Bana, Arpit A |
| Guide: | Mehta, Priti |
| Department: | Institute of Pharmacy |
| Publisher: | Nirma University, Ahmedabad |
| Place: | Ahmedabad |
| Year: | 2024 |
| Language: | English |
| Subject: | Characterization | Clinical Pre Clinical and Health | Formulations | Pharmacology and Pharmacy | Pharmacology and Toxicology | Pharmacy | Medical and Health Sciences |
| Dissertation/Thesis Note: | PhD; Institute of Pharmacy, Nirma University, Ahmedabad, Ahmedabad; 2024 |
| Fulltext: | Shodhganga |
| 000 | 00000ntm a2200000ua 4500 | |
| 001 | 456553 | |
| 003 | IN-AhILN | |
| 005 | 2024-10-10 17:51:48 | |
| 008 | __ | 241010t2024||||ii#||||g|m||||||||||eng|| |
| 035 | __ | |a(IN-AhILN)th_456553 |
| 040 | __ | |aNIRU_382481|dIN-AhILN |
| 041 | __ | |aeng |
| 100 | __ | |aBana, Arpit A|eResearcher |
| 110 | __ | |aInstitute of Pharmacy|bNirma University, Ahmedabad|dAhmedabad|ein|0U-0146 |
| 245 | __ | |aComparative Analytical Characterization of Selected Biosimilar Formulations Available in India |
| 260 | __ | |aAhmedabad|bNirma University, Ahmedabad|c2024 |
| 300 | __ | |dDVD |
| 502 | __ | |cInstitute of Pharmacy, Nirma University, Ahmedabad, Ahmedabad|d2024|bPhD |
| 518 | __ | |d2024|oDate of Award |
| 518 | __ | |oDate of Registration|d2018 |
| 520 | __ | |aThe significance of performing a comparative analytical similarity assessment cannot be overstated in the process of evaluating the quality of a biosimilar product and its regulatory submission. This is due to the fact that biosimilar products are not identical to the innovator product. Moreover, it is considered essential to establish appropriate shelf-life and storage conditions for a drug product to ensure the safety and efficacy of the product over its intended shelf-life, following its market authorization. In this thesis, analysis of critical product attributes of marketed Bevacizumab biosimilar-1, and biosimilar-2 (Bio-1, and Bio-2) and Erythropoietin-1, Erythropoietin-2, and Erythropoietin-3 (Epo-1, Epo-2, and Epo-3) biosimilar products were carried out in comparison to their reference product using state-of-the-art analytical techniques. Quantitative estimation of native protein was performed using UV-Visible spectrophotometer at 280 nm (UV280) and reverse phase high performance liquid chromatograp |
| 650 | __ | |aPharmacy|2UGC |
| 650 | __ | |aMedical and Health Sciences|2AIU |
| 653 | __ | |aCharacterization |
| 653 | __ | |aClinical Pre Clinical and Health |
| 653 | __ | |aFormulations |
| 653 | __ | |aPharmacology and Pharmacy |
| 653 | __ | |aPharmacology and Toxicology |
| 700 | __ | |eGuide|aMehta, Priti |
| 856 | __ | |uhttp://shodhganga.inflibnet.ac.in/handle/10603/572146|yShodhganga |
| 905 | __ | |afromsg |
User Feedback Comes Under This section.