Specificity of bioanalytical methods for pharmacokinetic support of biological macromolecular therapeutics is important

Bioanalysis

Volumn 3, Issue 6, 2011, Pages 567-569

  Findlay, John W A ^a  

^a NONE   (United States)

Author keywords

ligand binding assays; metabolism; pharmacokinetics; protein catabolism; specificity; validation

Indexed keywords

BIOTECHNOLOGICAL PROCEDURES; BIOTRANSFORMATION; EDITORIAL; HYBRIDIZATION; IMMUNOASSAY; IMMUNOGENICITY; LIGAND BINDING; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; MATHEMATICAL ANALYSIS; MEDICAL RESEARCH; PHARMACODYNAMICS; PHARMACOKINETICS; PROCESS OPTIMIZATION; PROTEIN DEGRADATION; SAFETY; SENSITIVITY AND SPECIFICITY; TOXICOKINETICS;

CHEMISTRY TECHNIQUES, ANALYTICAL; MACROMOLECULAR SUBSTANCES; MOLECULAR PROBE TECHNIQUES; OLIGONUCLEOTIDES; PROTEINS;

EID: 79953072995     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.11.12     Document Type: Editorial

References (2)

1. Pharmaceutical Research and Manufacturers report: Medicines in Development Biotechnology (2008). www.phrma.org/sites/phrma.org/files/ attachments/Biotech%20 2008.pdf
2. US FDA. Guidance for Industry: Bioanalytical Method Validation. US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, Rockville, MD, USA (2001). www.fda.gov/downloads/drugs/ guidancecomplianceregulatoryinformation/guidances/ ucm070107.pdf