Challenges in transferring bioanalytical methods

Drug Discovery World

Volumn 9, Issue 4, 2008, Pages 21-27

  Beaver, Chris ^a  

^a MDS Inc   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ACCURACY; ANALYTIC METHOD; ARTICLE; BIOASSAY; CALIBRATION; COST; DRUG INDUSTRY; DRUG SCREENING; GOOD MANUFACTURING PRACTICE; HIGH THROUGHPUT SCREENING; IMMUNOGENICITY; METHODOLOGY; PROCESS DEVELOPMENT; QUALITY CONTROL; STANDARDIZATION; VALIDATION PROCESS;

EID: 55349100883     PISSN: 14694344     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (6)

1. Guidance for Industry - Bioanalytical Method Validation (US Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research, May 2001).
2. Viswanathan, CT, Bansal, S, Booth, B, DeStefano, AJ, Rose, MJ, Sailstad, J, Shah, VP, Skelly, JP, Swann, PG, Weiner, R. Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. Pharmaceutical Research. 2007, 24:1962-73.
3. DeSilva, BS, Smith, WC, Weiner, R, Kelley, M, Smolec, J, Lee, B, Khan, M, Tacey, R, Hill, H, Celniker, A. Recommendations for the Bioanalytical Method Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Macromolecules, Pharmaceutical Research, 2003, 20(11): 1885-1900.
4. Mire-Sluis, AR, Barrett, YC, Devanarayan, V, Koren, E, Liu, H, Maia, M, Parish, T, Scott, G, Shankar, G, Shores, E, Swanson, SJ, Taniguchi, G, Wierda, D, Zuckerman, LA. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. Journal of Immunological Methods, 2004 289:1-16.
5. Gupta, SR, Indelicato, V, Jethwa, T, Kawabata, M, Kelley, AR, Mire-Sluis, SM, Richards, B, Rup, E, Shores, SJ, Swanson, E, Wakshull. Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics. Journal of Immunological Methods. 2007, 321:1-18.
6. DiMasi, JA, Hansen, RW, Grabowski, HG. The price of innovation: new estimates of drug development costs. Journal of Health Economics, 2003, 22:151-85.