General consideration on organization of summary in pharmaceutical research
YU Hong
ZHANG Yu-hu
Abstract：Pharmaceutical research is a basis for safety and efficacy studies in development process of pharmaceutical products. The summary of pharmaceutical research data should present an overall profile, including analysis and evaluation of results in each part of chemical development studies. The contents should provide comprehensive understanding of the product and its manufacturing process for applicants and reviewers. Based on the relevant guidelines, this article describes the suggested contents and key consideration for applicants and researcher, which will help to improve quality and efficiency of drug registration.
Keywords：pharmaceutical researchsummaryspecification
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( 277-279,295 )