2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance.
Bioanalysis
; 2(12): 1945-60, 2010 Dec.
Article
in En
| MEDLINE
| ID: mdl-21110739
ABSTRACT
The 4th Calibration and Validation Group Workshop on Recent Issues in Regulated Bioanalysis, a 2-day full immersion workshop, was organized by the Calibration and Validation Group. Contract research organizations, pharmaceutical companies and regulatory agencies came together to discuss several 'hot' topics concerning bioanalytical issues and regulatory challenges and to reach a consensus among panelists and attendees on many points regarding method validation of small and large molecules.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Biopharmaceutics
/
Pharmaceutical Preparations
/
Chemistry Techniques, Analytical
/
International Cooperation
Type of study:
Guideline
Limits:
Humans
Country/Region as subject:
America do norte
Language:
En
Journal:
Bioanalysis
Year:
2010
Document type:
Article
Affiliation country:
Canada