Bioanalytical Method Validation for Macromolecules in Support of Pharmacokinetic Studies
- 700 Downloads
The development and validation of ligand binding assays used in the support of pharmacokinetic studies has been the focus of various workshops and publications in recent years, all in an effort to establish a guidance document for standardization of these bioanalytical methods. This summary report of the workshop from 2003 focuses on the issues discussed in presentations and notes points of discussion and areas of consensus among the participants.
Key Wordsbioanalytical assay biological matrices immunoassay method validation
- 2.DeSilva, B., Smith, W., Weiner, R., Kelley, M., Smolec, J., Lee, B., Khan, M., Tacey, R., Hill, H., Celniker, A. 2003Recommendations for the bioanalytical method validation of ligand-binding assays tosupport pharmacokinetic assessments of macromoleculesPharm. Res.2018851900CrossRefPubMedGoogle Scholar
- 3.International Conference on Harmonization. ICH Q2A. Text on Validation of Analytical Procedures. Federal Register. 1995;60 FR 11260. http://www.fda.gov/cder/guidance/ichq2a.pdf..
- 4.International Conference on Harmonization. ICH Q2B. Validation of Analytical Procedures Methodology. Federal Register. 1997;62 FR 27463. http://www.fda.gov/cder/guidance/1320fnl.pdf..
- 5.US Department of Health and Human Services. Draft Guidance for Industry: Analytical Procedures and Methods Validation, Chemistry, Manufacturing and Controls Documentation. Rockville, MD:US Dept of Health and Human Services, Food and Drug Administration. Aug 2000. http://www.fda.gov/cder/guidance/2396dft.pdf..