General consideration on organization of pharmaceutical research summary
YU Hong
ZHANG Yu-hu
Abstract:Pharmaceutical research is a basis for safety and efficacy studies in pharmaceutical product de-velopment process. The summary for pharmaceutical research data should present a full profile, including analysis and evaluation of results in each part of chemical development studies. These contents should provide comprehen-sive understanding of the product and its manufacturing process for applicants and reviewers. Based on the relevant guidelines, this article described 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:3( 473-475 )
