QCT-01.1 Analytical Method Validation and Requirements

2016 ◽  
pp. 31-36
Keyword(s):  
Method Validation ◽  
Analytical Method ◽  
Analytical Method Validation

Analytical method validation for biomarkers as a drug development tool: points to consider

Bioanalysis ◽  
2021 ◽  
Author(s):  
Yoshiaki Ohtsu ◽  
Seiji Tanaka ◽  
Harue Igarashi ◽  
Masaaki Kakehi ◽  
Tamiki Mori ◽  
...  
Keyword(s):  
Method Validation ◽  
Analytical Method ◽  
Analytical Methods ◽  
Drug Efficacy ◽  
Binding Assays ◽  
Analytical Method Validation ◽  
Development Tool ◽  
Post Marketing ◽  
Global Harmonization ◽  
Endogenous Metabolites

Biomarkers are an important drug developmental tool. Assessment of quantitative analytical methods of biomarkers is not included in any regulatory documents in Japan. Use of biomarkers in clinical evaluations and supporting the post-marketing evaluation of drug efficacy and/or adverse reactions requires assessment and full validation of analytical methods for these biomarkers. The Biomarker Analytical Method Validation Study Group is a research group in Japan comprising industry and regulatory experts. Group members discussed and prepared this ‘points to consider document’ covering measurements of endogenous metabolites/peptides/proteins by ligand binding assays and chromatographic methods with or without mass spectrometry. We hope this document contributes to the global harmonization of biomarker assay validation.

Organic acids and alcohols quantification by HPLC/RID in sugarcane vinasse: analytical method validation and matrix effect assessment

2019 ◽  
pp. 1-12
Author(s):  
Alan Nascimento Bernardes ◽  
Leandro Augusto Gouvêa de Godoi ◽  
Priscila Rosseto Camiloti ◽  
Absai da Conceição Gomes ◽  
Bruna Larissa Sandy Sanchez ◽  
...  
Keyword(s):  
Organic Acids ◽  
Method Validation ◽  
Matrix Effect ◽  
Analytical Method ◽  
Analytical Method Validation ◽  
Effect Assessment ◽  
Sugarcane Vinasse

scholarly journals Analytical method validation, dissipation and safety evaluation of combination fungicides fenamidone + mancozeb and iprovalicarb + propineb in/on tomato

2020 ◽  
Vol 57 (6) ◽  
pp. 2061-2069
Author(s):  
Yengkhom Bijen Kumar ◽  
T. P. Ahammed Shabeer ◽  
Manjusha Jadhav ◽  
Kaushik Banerjee ◽  
Sandip Hingmire ◽  
...  
Keyword(s):  
Method Validation ◽  
Analytical Method ◽  
Safety Evaluation ◽  
Analytical Method Validation
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