Krys J. Miller

Bio: Krys J. Miller is an academic researcher from Amgen. The author has contributed to research in topics: Bioanalysis. The author has an hindex of 3, co-authored 3 publications receiving 1672 citations.

Bioanalytical method validation--a revisit with a decade of progress.

Abstract: This report is a synthesis of (1) the earlier conference on Analytical Methods Validation−Bioavailability, Bioequivalence and Pharmacokinetic Studies (Conference held in Arlington, VA, December 3–5, 1990 and the report published in Pharmaceutical Research, 9: 588-592, 1992) and (2) the workshop on “Bioanalytical Methods Validation—A Revisit with a Decade of Progress,” (Workshop held in Arlington, VA, January 12–14, 2000), sponsored by the American Association of Pharmaceutical Scientists and the U. S. Food and Drug Administration. The bioanalytical method validation workshop of January 12–14, 2000 was directed towards small molecules. A separate workshop was held in March 1–3, 2000 to discuss validation principles for macromolecules. The purpose of this report is to represent the progress in analytical methodologies over the last decade and assessment of the major agreements and issues discussed with regard to small molecules at both the conference and the workshop. The report is also intended to provide guiding principles for validation of bioanalytical methods employed in support of bioavailability, bioequivalence, and pharmacokinetic studies in man and in animals.

Workshop on Bioanalytical Methods Validation for Macromolecules: Summary Report

Abstract: 1. To determine industry and regulatory standards established for bioanalytical method validation in support of the estimation and characterization of macromolecules in the preclinical and clinical stages of drug development. 2. To evaluate special validation considerations for quantitative, macromolecule-detecting technologies that have emerged since 1990 including immunoassays, cell-based assays, antibody titers, and automation in the laboratory. 3. To address the strengths/limitations and advantages/ disadvantages of assay-customized approaches to validation that focus on assay parameters specific to the intended use of the assay. 4. To develop a 2000 workshop report regarding appropriate bioanalytical validation criteria and standardization of terminology for the above to be used by regulatory agencies to draft new guidelines for the bioanalytical validation criteria for macromolecules quantitation.

Quantitative Small Molecule Bioanalysis Using Chip-Based NanoESI-MS/MS

Abstract: A fully automated chip-based nanoelectrospray (nanoESI) system, NanoMate® 100 (Advion Bio-Sciences, Inc., Ithaca, NY), was evaluated for its application on quantitative bioanalysis of small molecul...

Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays

Abstract: The Third AAPS/FDA Bioanalytical Workshop, entitled “Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays” was held on May 1–3, 2006 in Arlington, VA. The format of this workshop consisted of presentations on bioanalytical topics, followed by discussion sessions where these topics could be debated, with the goal of reaching consensus, or identifying subjects where addition input or clarification was required. The discussion also addressed bioanalytical validation requirements of regulatory agencies, with the purpose of clarifying expectations for regulatory submissions. The proceedings from each day were reviewed and summarized in the evening sessions among the speakers and moderators of the day. The consensus summary was presented back to the workshop on the last day and was further debated. This communication represents the distillate of the workshop proceedings and provides the summary of consensus reached and also contains the validation topics where no consensus was reached.

Recommendations for the Bioanalytical Method Validation of Ligand-binding Assays to Support Pharmacokinetic Assessments of Macromolecules

Abstract: Purpose.With this publication a subcommittee of the AAPS Ligand Binding Assay Bioanalytical Focus Group (LBABFG) makes recommendations for the development, validation, and implementation of ligand binding assays (LBAs) that are intended to support pharmacokinetic and toxicokinetic assessments of macromolecules.