Manuscripts

Scientific Literature Provides Foundation for Computations and Analysis in STATLIA MATRIX

Partial List of References for STATLIA MATRIX Analysis

Manuscripts Published by Brendan Bioanalytics Technical Staff

5PL and 4PL Curve Fitting Model

Gottschalk, P.G.; Dunn, J.R. The Five Parameter Logistic: A Characterization And Comparison With The Four Parameter Logistic.  Analytical Biochemistry 2005, 343, 54 – 65. REQUEST MANUSCRIPT

Dunn J.R., Wild D. Calibration Curve Fitting. The Immunoassay Handbook, Theory and Applications of Ligand Binding, ELISA and Related Techniques 2013, 4th Edition, 323 – 336.

Residual Parallelism and Relative Potency

Gottschalk PG, Dunn JR. Measuring Parallelism, Linearity and Relative Potency in Immunoassay and Bioassay Data, Journal of Pharmaceutical Biostatistics 2005, 15 (3), 437 – 463. REQUEST MANUSCRIPT

Concentration Error Determinations

Gottschalk, P.G.; Dunn, J.R. Determining the Error of Dose Estimates and Minimum and Maximum Acceptable Concentrations from Assays with Nonlinear Dose-Response Curves.  Computer Methods and programs in Biomedicine 2005, 80, 204 – 215. REQUEST MANUSCRIPT

Manuscripts Published by Regulatory and Scientific Community

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM). Bioanalytical Method Validation, Guidance for industry. Biopharmaceutics, May 2018.

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM). Immunogenicity Testing of Therapeutic Protein Products – Developing and Validating Assays for Anti-Drug Antibody Detection, Guidance for Industry. Pharmaceutical Quality/CMC, January 2019.

USP Chapters <1032> Design and Development of Biological Assays, <1033> Biological Assay Validation, <1034> Analysis of Biological Assays. United States Pharmacopeia Convention, 2013.

European Pharmacopeia 5.3. Statistical Analysis of Results of Biological Assays and Tests 2003, 4375-4406.

Dudley, R.A.; Edwards, P; Ekins, R.P.; Finney, D.J.; McKenzie, I.G.M.; Raab, G.M.; Rodbard, D; Rodgers, R.P.C. Guidelines for Immunoassay Data Processing. Clinical Chemistry 1985, 31 (8), 1264-1271.

DeSilva B, Smith W, 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.

Hauck W, Capen R, Callahan J, De Muth J, Hsu H, Lansky D, Sajjadi N, Seaver S, Singer R, Weisman D. Assessing Parallelism Prior to Determining Relative Potency. PDA Journal of Pharmaceutical Science and Technology 2005, 59 (2), 127 – 137.