Troubleshooting PEG-hGH detection supporting pharmacokinetic evaluation in growth hormone deficient patients

Journal of Pharmacological and Toxicological Methods

Volumn 61, Issue 2, 2010, Pages 92-97

  Myler, Heather A ^a   McVay, Sami ^a   Kratzsch, Juergen ^b  

^a AMBRX INC   (United States)

^b UNIVERSITY HOSPITAL LEIPZIG   (Germany)

Author keywords

Acid dissociation; Drug detection methods; Growth hormone; Human serum; Pharmacokinetics; Total versus free ligand binding assays

Indexed keywords

4 (2 HYDROXYETHYL) 1 PIPERAZINEETHANESULFONIC ACID; BILIRUBIN; CASEIN; GLYCINE; GROWTH HORMONE BINDING PROTEIN; GROWTH HORMONE BINDING PROTEIN 3; HEMOGLOBIN; HUMAN GROWTH HORMONE; HYDROCHLORIC ACID; LIPID; MACROGOL; UNCLASSIFIED DRUG;

ACCURACY; ARTICLE; CONTROLLED STUDY; CROSS REACTION; DILUTION; DISSOCIATION; DRUG EXPOSURE; ELECTROCHEMILUMINESCENT IMMUNOSORBENT ASSAY; GROWTH HORMONE DEFICIENCY; HORMONE DETERMINATION; HUMAN; IMMUNOASSAY; MOLECULAR RECOGNITION; MOLECULAR STABILITY; NONHUMAN; QUALITY CONTROL; SENSITIVITY AND SPECIFICITY; VALIDATION PROCESS;

ACIDS; ANIMALS; ANTIBODY SPECIFICITY; CROSS REACTIONS; DELAYED-ACTION PREPARATIONS; GROWTH HORMONE; HUMAN GROWTH HORMONE; HUMANS; IMMUNOGLOBULIN G; IMMUNOGLOBULIN M; IMMUNOSORBENT TECHNIQUES; INDICATORS AND REAGENTS; MICE; POLYETHYLENE GLYCOLS; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS;

EID: 77950524946     PISSN: 10568719     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vascn.2009.12.004     Document Type: Article

References (7)

1. DeSilva B., Smith W., Weiner R., Kelley M., Smolec J., Lee B., et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharmaceutical Research 2003, 20:1885-1900.
2. Guidance for Industry: Bioanalytical Method Validation 2001, Food and Drug Administration, US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, Rockville, MD.
3. Lee J., Ma H. Specificity and selectivity evaluations of ligand binding assay of protein therapeutics against concomitant drugs and related endogenous proteins. AAPS Journal 2007, 9:E164-E170.
4. Patton A., Mullenix M.C., Swanson S.J., Koren E. An acid dissociation bridging ELISA for detection of antibodies directed against therapeutic proteins in the presence of antigen. Journal of Immunological Methods 2005, 304:189-195.
5. Shah V.P., Midha K.K., Digh S., McGilveray I.J., Skelly J.P., Yacobi A., et al. Analytical methods validation: Bioavailibility, bioequivalence, and pharmacokinetic studies. Journal of Pharmaceutical Sciences 1992, 81:309-312.
6. Smolec J., DeSilva B., Smith W., Weiner R., Kelly M., Lee B., et al. Bioanalytical method validation for macromolecules in support of pharmacokinetic studies. Pharmaceutical Research 2005, 22:1425-1431.
7. Viswanathan C.T., Bansal S., Booth B., DeStefano A.J., Rose M.J., Sailstad J., et al. Workshop/conference report - Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays. AAPS Journal 2007, 9:E30-E42.