| Literature DB >> 29310842 |
Marianne Saldanha1, Prajakta Dandekar2, Ratnesh Jain3.
Abstract
Antibody-drug conjugates (ADCs) and bispecific antibodies are becoming increasingly popular. However, their complex structures mandate stringent regulatory guidelines to ensure their safety and efficacy. We have briefly reviewed the existing regulatory guidelines and presented our perspectives on refining them to hasten the transition of these drugs from laboratories to market.Keywords: antibody–drug conjugates; binding activity; bispecific antibodies; potency; regulatory guidelines
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Year: 2018 PMID： 29310842 DOI： 10.1016/j.tibtech.2017.12.004
Source DB: PubMed Journal: Trends Biotechnol ISSN： 0167-7799 Impact factor: 19.536