Studies for structure determination and quality specification of synthetic peptide drugs
WANG Peng
Abstract：Based on Guidance on Chemistry,Manufacturing,and Controls Studies for Synthetic Peptide Drugs and the common issues about drug registration,this paper summarized and analyzed some key problems on structure determination and quality specification studies about synthetic peptide drugs.A number of technical re-quirements,such as the requirements for impurities study,were deeply clarified,while some controversial issues in the process of drafting the guidance were described.
Keywords：synthetic peptideguidancestructure determinationquality specificationtechnical require-ment .
Publication Date：2009-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 2302-2305,2319 )