質量標準

質量標準

陽光德美運行項目滿足以下法規要求

陽光德美運行項目滿足以下法規要求

《藥物臨床試驗質量管理規范》
《藥物非臨床研究質量管理規范》
《藥物臨床試驗生物樣本分析實驗室管理指南(試行)》
《生物樣品定量分析方法驗證指導原則(2015年版中國藥典)》
《化學藥品新注冊分類申報資料要求(試行)》
《藥品數據管理規范(征求意見稿)》

FDA. Guidance for Industry - Bioanalytical Method Validation. 2018.05.
FDA. Guideline on Bioanalytical Method Validation. 2012.02.
FDA. Immunogenicity Testing of Therapeutic Protein Products-Developing and Validating Assays for Anti-Drug Antibody Detection Guidance for Industry. 2019.01.
FDA. Guidance for Industry-Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products. 2016.04.
FDA. Good Laboratory Practice for Nonclinical Laboratory Studies. 21 CFR Part 58.

Principles on Good Laboratory Practice 
Good Clinical Laboratory Practice(GCLP)
Guideline on bioanalytical method validation
Guideline on Immunogenicity assessment of therapeutic proteins
GAMP 5
Bioanalytical Method Validation(M10)