Biologics sponsors are encouraged to follow established, voluntary standards when developing new products, the Food and Drug Administration (FDA) said in new draft guidance it issued on Dec. 19 (82 Fed. Reg. 60,204).
The AAPS Journal: High-Throughput Biophysical Analysis of Protein Therapeutics to Examine Interrelationships Between Aggregate Formation and Conformational Stability AAPS PharmSciTech: Biophysics and Thermodynamics: The Scientific Building Blocks of Bio-inspired Drug Delivery Nano Systems Pharmaceutical Research: Biophysical and Structural Characterization of Polyethylenimine-Mediated siRNA Delivery in Vitro Use of Biophysical Characterization in Preformulation
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