Comparison of bioanalytical methods for the quantitation of PEGylated human insulin

Journal of Immunological Methods

Volumn 396, Issue 1-2, 2013, Pages 1-7

  de Dios, Kristine ^a   Manibusan, Anthony ^a   Marsden, Robin ^a   Pinkstaff, Jason ^a  

^a AMBRX INC   (United States)

Author keywords

Bioanalysis; ECL; ELISA; Gyrolab; LC MS MS; Ligand binding assay

Indexed keywords

BOVINE INSULIN; IMMUNOGLOBULIN M ANTIBODY; PEGYLATED HUMAN INSULIN; RECOMBINANT HUMAN INSULIN; STREPTOZOCIN; UNCLASSIFIED DRUG;

ANALYTIC METHOD; ANIMAL EXPERIMENT; ANIMAL MODEL; AREA UNDER THE CURVE; CHEMILUMINESCENCE IMMUNOASSAY; CONTROLLED STUDY; COST BENEFIT ANALYSIS; ELECTROCHEMILUMINESCENCE ASSAY; ENZYME LINKED IMMUNOSORBENT ASSAY; EXPERIMENTAL RAT; GYROLAB METHOD; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HYPERGLYCEMIA; IN VIVO STUDY; INSTRUMENT VALIDATION; INTERMETHOD COMPARISON; LIMIT OF QUANTITATION; MALE; MAXIMUM PLASMA CONCENTRATION; MEASUREMENT ACCURACY; NONHUMAN; PRIORITY JOURNAL; QUADRUPOLE MASS SPECTROMETRY; RAT; REVIEW; SENSITIVITY ANALYSIS; SINGLE DRUG DOSE; TANDEM MASS SPECTROMETRY; VALIDATION PROCESS;

%C.V.; %R.E.; %T.E.; ACETONITRILE; ACN; AREA UNDER THE CURVE; AUC; BIOANALYSIS; C(MAX); DITHIOTHREITOL; DTT; ECL; ECLA; ELECTROCHEMILUMINESCENCE; ELECTROCHEMILUMINESCENCE ASSAY; ELISA; ENZYME-LINKED IMMUNOSORBENT ASSAY; FA; FORMIC ACID; GYROLAB; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HIGH QUALITY CONTROL; HPLC; HQC; INTERNAL STANDARD; IPA; IS; ISOPROPYL ALCOHOL; LBA; LC-MS/MS; LIGAND-BINDING ASSAY; LIQUID CHROMATOGRAPHY MASS SPECTROMETRY; LLOQ; LOW QUALITY CONTROL; LOWER LIMIT OF QUANTITATION; LQC; MAB; MAXIMAL PLASMA CONCENTRATION; MEOH; METHANOL; MID QUALITY CONTROL; MONOCLONAL ANTIBODY; MQC; PEG; PERCENT COEFFICIENT OF VARIATION; PERCENT RECOVERY EFFICIENCIES; PERCENT TOTAL ERROR; PHARMACOKINETIC; PK; POLYETHYLENE GLYCOL; QC; QUALITY CONTROL; RELATIVE LIGHT UNITS; RLU; SD; SPRAGUE-DAWLEY; STREPTOZOTOCIN; STZ; TFA; TRI-FLUORO ACETIC ACID; ULOQ; UPPER LIMIT OF QUANTITATION;

CHROMATOGRAPHY, LIQUID; COST-BENEFIT ANALYSIS; ELECTROCHEMISTRY; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; INSULIN; LUMINESCENCE; POLYETHYLENE GLYCOLS; QUALITY CONTROL; REFERENCE STANDARDS; TANDEM MASS SPECTROMETRY;

EID: 84884353423     PISSN: 00221759     EISSN: 18727905     Source Type: Journal    
DOI: 10.1016/j.jim.2013.07.007     Document Type: Review

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