Regulatory observations in bioanalytical determinations.
Bioanalysis
; 2(7): 1325-9, 2010 Jul.
Article
en En
| MEDLINE
| ID: mdl-21083243
ABSTRACT
The concept of measuring analytes in biological media is a long-established area of the quantitative sciences that is employed in many sectors. While academic research and R&D units of private firms have been in the forefront of developing complex methodologies, it is the regulatory environment that has brought the focus and rigor to the quality control of the quantitative determination of drug concentration in biological samples. In this article, the author examines the regulatory findings discovered during the course of several years of auditing bioanalytical work. The outcomes of these findings underscore the importance of quality method validation to ensure the reliability of the data generated. The failure to ensure the reliability of these data can lead to potential risks in the health management of millions of people in the USA.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Preparaciones Farmacéuticas
/
Técnicas de Química Analítica
/
Regulación Gubernamental
Tipo de estudio:
Prognostic_studies
Límite:
Humans
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Bioanalysis
Año:
2010
Tipo del documento:
Article
País de afiliación:
Estados Unidos