Regulatory challenges and landscapes of monoclonal antibody registration (Record no. 23412)
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| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20250916135927.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 250916b xxu||||| |||| 00| 0 eng d |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | AIKTC-KRRC |
| Transcribing agency | AIKTC-KRRC |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 27202 |
| Author | Surjonarayan, Motilal |
| 245 ## - TITLE STATEMENT | |
| Title | Regulatory challenges and landscapes of monoclonal antibody registration |
| Remainder of title | : global outlook |
| 250 ## - EDITION STATEMENT | |
| Volume, Issue number | Vol.16(5) |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Place of publication, distribution, etc. | Bhopal |
| Name of publisher, distributor, etc. | Innovare Academic Sciences Pvt Ltd |
| Year | 2024 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Pagination | 30-41p. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | This review aims to illuminate the unprecedented growth and versatile therapeutic landscape of monoclonal antibody (mAb) products, highlighting their significant impact on diverse medical fields such as oncology, septicemia treatment, infection management, and substance abuse disorder interventions. This review outlines the challenges associated with the development, manufacturing, and regulatory approval of monoclonal antibodies, emphasizing the need for diligent attention to overcome these complexities. The review comprehensively examines the historical evolution and therapeutic applications of monoclonal antibodies, emphasizing their potent and versatile characteristics that have enabled successful interventions in challenging regulatory approvals. It delves into the critical considerations in manufacturing, regulatory navigation, and the strategic integration of expedited approval pathways, providing a holistic understanding of the intricate terrain of innovation, clinical translation, and impactful patient care in the realm of monoclonal antibody products. Monoclonal antibodies have significantly advanced medical treatment in various domains, revolutionizing cancer therapy, offering new avenues for septicemia management, augmenting the arsenal against infections, and opening novel pathways for addressing substance abuse disorders. Their development and regulatory approval are associated with challenges of scientific innovation, manufacturing, and regulatory compliance. Despite the challenges, monoclonal antibodies have demonstrated remarkable potential in addressing complex medical conditions. The review serves as a compass, guiding researchers, clinicians, and regulatory authorities through the intricate terrain of monoclonal antibody innovation and clinical translation. It emphasizes the need for diligent attention to overcome the complexities associated with their development and regulatory approval while highlighting their significant impact on advancing patient care. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| 9 (RLIN) | 4639 |
| Topical term or geographic name entry element | PHARMACEUTICS |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 27164 |
| Co-Author | Mishra, Sangita |
| 773 0# - HOST ITEM ENTRY | |
| International Standard Serial Number | 2656-0097 |
| Title | International journal of pharmacy and pharmaceutical science |
| Place, publisher, and date of publication | Bhopal Innovare Academic Sciences Pvt Ltd |
| 856 ## - ELECTRONIC LOCATION AND ACCESS | |
| URL | https://journals.innovareacademics.in/index.php/ijpps/article/view/50723 |
| Link text | Click here |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Dewey Decimal Classification |
| Koha item type | Articles Abstract Database |
| Withdrawn status | Lost status | Source of classification or shelving scheme | Damaged status | Not for loan | Home library | Current library | Shelving location | Date acquired | Total Checkouts | Barcode | Date last seen | Price effective from | Koha item type |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dewey Decimal Classification | School of Pharmacy | School of Pharmacy | Archieval Section | 16/09/2025 | 2025-1439 | 16/09/2025 | 16/09/2025 | Articles Abstract Database |