Drug analysis of biological samples. A survey of validation approaches in chromatography in the UK pharmaceutical industry.
1. The results of a survey on validation of analytical chromatographic methods are reported. The survey was carried out in 1990 within most of the principal British Pharmaceutical Companies. 2. A general method of validation is established from the collated results. 3. A comparison is made with existing reports from international meetings.
Arnoux
P
P
Bioanalytical and Pharmacokinetics Department, Sanofi Winthrop Ltd, Wythenshawe, Manchester, UK.
Morrison
R
R
D002626:Chemistry, Pharmaceutical / Q000379:methods* / Q000592:standards; D002845:Chromatography / Q000379:methods; D007221:Industry / Q000379:methods*; D004364:Pharmaceutical Preparations / Q000032:analysis*; D011786:Quality Control; D015203:Reproducibility of Results; D006113:United Kingdom
D004364:Pharmaceutical Preparations