Bioanalytical method validation--a revisit with a decade of progress

Pharm Res. 2000 Dec;17(12):1551-7. doi: 10.1023/a:1007669411738.

Authors

V P Shah¹, K K Midha, J W Findlay, H M Hill, J D Hulse, I J McGilveray, G McKay, K J Miller, R N Patnaik, M L Powell, A Tonelli, C T Viswanathan, A Yacobi

Affiliation

¹ Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, MD 20857, USA.

PMID: 11303967
DOI: 10.1023/a:1007669411738

No abstract available

Publication types

Clinical Trial

MeSH terms

Biological Assay
Biological Availability
Indicators and Reagents
Pharmaceutical Preparations / analysis*
Pharmacokinetics*
Reproducibility of Results
Therapeutic Equivalency

Substances

Indicators and Reagents
Pharmaceutical Preparations