Bioanalytical method validation - A revisit with a decade of progress

Pharmaceutical Research

Volumn 17, Issue 12, 2000, Pages 1551-1557

  Shah, V P ^a   Midha, K K ^c   Findlay, J W A ^d   Hill, H M ^e   Hulse, J D ^f   McGilveray, I J ^g   McKay, G ^c   Miller, K J ^h   Patnaik, R N ^a   Powell, M L ⁱ   Tonelli, A ^j   Viswanathan, C T ^a   Yacobi, A ^b  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b Taro Pharmaceuticals   (United States)

^c UNIVERSITY OF SASKATCHEWAN   (Canada)

^d PFIZER INC   (United States)

^e HUNTINGDON LIFE SCIENCES   (United Kingdom)

^f MDS Inc   (Canada)

^g McGilveray Pharmacon Inc   (Canada)

^h AMGEN INC   (United States)

ⁱ BRISTOL MYERS SQUIBB   (United States)

^j PURDUE PHARMA L P   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; BIOAVAILABILITY; CONFERENCE PAPER; FOOD AND DRUG ADMINISTRATION; PHARMACEUTICAL ENGINEERING; PHARMACOKINETICS; PRIORITY JOURNAL; VALIDATION PROCESS;

BIOLOGICAL ASSAY; BIOLOGICAL AVAILABILITY; INDICATORS AND REAGENTS; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; REPRODUCIBILITY OF RESULTS; THERAPEUTIC EQUIVALENCY;

EID: 0034469255     PISSN: 07248741     EISSN: None     Source Type: Journal    
DOI: 10.1023/A:1007669411738     Document Type: Conference Paper

References (11)

1. International Conference on Harmonization: Guideline on validation of analytical procedures: Methodology
2. International Conference on Harmonization: Guideline on validation of analytical procedures: Definitions and terminology
3. Validation in practice - Experience with immunoassay
4. Validation of immunoassay for macromolecules from biotechnology
5. Validation of immunoassays for bioanalysis: A pharmaceutical industry perspective
6. Validation of bioanalytical chromatographic methods
7. Validation of bioanalytical methods
8. An assessment of the 4-6-20 rule of acceptance of analytical runs in bioavailability, bioequivalence, and pharmacokinetic studies
9. Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies
10. Rational experimental design for bioanalytical methods validation. Illustration using an assay method for total captopril in plasma