A step-wise approach for transfer of immunogenicity assays during clinical drug development

AAPS Journal

Volumn 11, Issue 3, 2009, Pages 526-534

  Tatarewicz, Suzanna ^a   Moxness, Michael ^a   Weeraratne, Dohan ^a   Zhou, Lei ^a   Hale, Michael ^a   Swanson, Steven J ^a   Chirmule, Narendra ^a  

^a AMGEN INC   (United States)

Author keywords

Biacore; Bioanalytical; Concordance; ELISA; Method transfer; Robustness

Indexed keywords

HORSERADISH PEROXIDASE; PANITUMUMAB; STREPTAVIDIN;

ARTICLE; BIOASSAY; ENZYME LINKED IMMUNOSORBENT ASSAY; IMMUNOGENICITY; KAPPA STATISTICS; LABORATORY TEST; QUALITATIVE ANALYSIS; QUANTITATIVE ANALYSIS; SIGNAL NOISE RATIO; STATISTICAL ANALYSIS;

DRUG DESIGN; ENZYME-LINKED IMMUNOSORBENT ASSAY; REPRODUCIBILITY OF RESULTS;

EID: 73349094029     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-009-9130-3     Document Type: Article

References (10)

1. Benson C. Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices. www.fda.gov ; 2008.
2. X Bland X Altman 1986 Statistical methods for assessing agreement between two methods for clinical measurement Lancet 8 307 310
3. G de Fontenay 2008 Analytical method transfer: new descriptive approach for acceptance criteria definition J Pharm Biomed Anal 46 104 112 17961955 10.1016/j.jpba.2007.09.007 (Pubitemid 350225645)
4. FDA. Question to the Sponsor. http://www.fda.gov/CbER/products/pentacel/ pentacel060707L.htm ; 2007.
5. L Lin 1992 Assay validation using the concordance correlation coefficient Biometrics 48 599 604 10.2307/2532314
6. L Lin 2000 A note on the concordance correlation coefficient Biometrics 56 324 325 10.1111/j.0006-341X.2000.00775.x
7. Lofgren S Dhandhapani JJ Pennucci CM Abbot DT Mytych A Kaliyaperumal, et al. 2007 Comparing ELISA and surface plasmon resonance for assessing clincial immunogenicity of panitumumab J Immunol 178 7467 7472 17513798 1:CAS:528:DC%2BD2sXlsVOksb8%3D
8. D Schuirmann 1987 A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability J Pharmacokinet Biopharm 15 6570680 10.1007/BF01068419
9. JR Schwenke DK O'Connor 2008 Design and analysis of analytical method transfer studies J Biopharm Stat 18 1013 1033 18781533 10.1080/10543400802287354
10. J Zhong K Lee Y Tsong 2008 Statistical assessment of analytical method transfer J Biopharm Stat 18 1005 1012 18781532 10.1080/10543400802287347