Analysis of key problems on synthesis 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 key problems on synthesis of pep-tide drugs. A number of technical requirements, such as the requirements for starting materials and synthesis informa-tion, were deeply clarified, and controversial issues in the process of drafting the guidance were described.
Keywords:synthetic peptideguidancesynthesistechnical requirement
Publication Date:2010-01-01
Online Publishing Date:2026-08-14(First online date of this platform, not the publication date of the document)
Pages:4( 102-105 )
CHINESE JOURNAL OF NEW DRUGS

CHINESE JOURNAL OF NEW DRUGS

PKUISTIC
ISSN:1003-3734
Year, Vol.(Issue):2010,19(2)