Development of a robust functional cell-based assay for replacing the rabbit blood sugar bioidentity test of insulin glargine drug substance

Author:

Yie Junming,Dey Monisha,Su Jianying,Sergi Joseph,Zhang Ying,Le Thuan Hong,Kashi Sandhya,Gurney Kevin

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference21 articles.

1. USP<121> Insulin Assays: Rabbit Blood Sugar Method - Quantitative,2020

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3. Specifications: Test Procedures and Acceptance Criteria for Biotechnological/biological Products, Q6B ICH HARMONISED TRIPARTITE GUIDELINE,1999

4. New perspectives into the molecular pathogenesis and treatment of type 2 diabetes;Saltiel;Cell,2001

5. Mechanisms of insulin action and insulin resistance;Petersen;Physiol. Rev.,2018

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