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Volumn 24, Issue 10, 2007, Pages 1962-1973

Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays

(10) Viswanathan, C T a Bansal, Surendra b Booth, Brian a DeStefano, Anthony J c Rose, Mark J d Sailstad, Jeffrey e Shah, Vinod P f Skelly, Jerome P f Swann, Patrick G a Weiner, Russell g

a CENTER FOR DRUG EVALUATION AND RESEARCH (United States)

b HOFFMANN LA ROCHE INC (United States)

c PROCTER AND GAMBLE PHARMACEUTICALS (United States)

d AMGEN INC (United States)

e Sailstad and Associates (United States)

f Bristol Myers Squibb Inc ^*

g BRISTOL MYERS SQUIBB (United States)

Author keywords

Bioanalytical; Bioequivalence; LC MS MS; Ligand binding; Validation

Indexed keywords

DRUG METABOLITE;

AFFINITY CHROMATOGRAPHY; BINDING ASSAY; CHEMICAL ANALYSIS; CHROMATOGRAPHY; LIGAND BINDING; MEDICAL TECHNOLOGY; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; REPRODUCIBILITY; REVIEW; SAMPLING; VALIDATION PROCESS;

EID: 34548550429 PISSN: 07248741 EISSN: 1573904X Source Type: Journal
DOI: 10.1007/s11095-007-9291-7 Document Type: Review

Times cited : (635)

References (5)

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- Shah, V.P.¹ Midha, K.K.² Dighe, S.V.³

2
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- Bioanalytical method validation-a revisit with a decade of progress
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- V. P. Shah, K. K. Midha, J. W. A. 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, and A. Yacobi. Bioanalytical method validation-a revisit with a decade of progress. Pharm. Res. 17(12):1551-1557 (2000).
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- Shah, V.P.¹ Midha, K.K.² Findlay, J.W.A.³ Hill, H.M.⁴ Hulse, J.D.⁵ McGilveray, I.J.⁶ McKay, G.⁷ Miller, K.J.⁸ Patnaik, R.N.⁹ Powell, M.L.¹⁰ Tonelli, A.¹¹ Viswanathan, C.T.¹² Yacobi, A.¹³

3
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- Food and Drug Administration. US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research Rockville, MD
- Food and Drug Administration. Guidance for Industry: Bioanalytical Method Validation, US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, Rockville, MD, 2001.
- (2001) Guidance for Industry: Bioanalytical Method Validation

4
- 10744230729
- Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules
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- B. DeSilva, W. Smith, R. Weiner, M. Kelley, J. Smolec, B. Lee, M. Khan, R. Tacey, H. Hill, and A. Celniker. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm. Res. 20(11):1885-1900 (2003).
- (2003) Pharm. Res. , vol.20 , pp. 1885-1900
- Desilva, B.¹ Smith, W.² Weiner, R.³ Kelley, M.⁴ Smolec, J.⁵ Lee, B.⁶ Khan, M.⁷ Tacey, R.⁸ Hill, H.⁹ Celniker, A.¹⁰

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- Food and Drug Administration. US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research Rockville, MD
- Food and Drug Administration. Draft Guidance for Industry: Safety Testing of Drug Metabolites, US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, Rockville, MD, 2005.
- (2005) Draft Guidance for Industry: Safety Testing of Drug Metabolites

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