A risk-based analysis of the AAPS conference report on quantitative bioanalytical methods validation and implementation-Reference-Cited by-同舟云学术

A risk-based analysis of the AAPS conference report on quantitative bioanalytical methods validation and implementation

Published:2009-08 Issue:23 Volume:877 Page:2235-2243
ISSN:1570-0232
Container-title:Journal of Chromatography B
language:en
Short-container-title:Journal of Chromatography B

Author:

Boulanger Bruno,Rozet Eric,Moonen François,Rudaz Serge,Hubert Philippe

Publisher

Elsevier BV

Subject

Cell Biology,Clinical Biochemistry,Biochemistry,General Medicine,Analytical Chemistry

Reference30 articles.

1. Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays

2. Guidance for Industry: Bioanalytical Method Validation,2001

3. International Conference on Harmonization of Technical Requirements for registration of Pharmaceuticals for Human Use, Topic Q2 (R1): Validation of Analytical Procedures: Text and Methodology,2005

Cited by 42 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Size exclusion chromatography of biopharmaceutical products: From current practices for proteins to emerging trends for viral vectors, nucleic acids and lipid nanoparticles;Journal of Chromatography A;2024-05

2. BIOANALYTICAL METHOD VALIDATION: A COMPREHENSIVE ASSESSMENT OF VARIOUS REGULATORY GUIDELINES;Indian Drugs;2023-07-03

3. Development of a Bioanalytical Method by UHPLC-ESI-TQD-MS for the Quantification of Digoxin in Plasma;Revista Brasileira de Farmacognosia;2023-05-12

4. Development, transfer and validation of a HPLC-DAD method for analysis of six herbal medicines marketed in D.R. Congo: Fingerprinting and stability study;Phytomedicine Plus;2023-05

5. Assessment of the Quality of Injectable Antibiotics in Benin;The American Journal of Tropical Medicine and Hygiene;2022-07-13