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Shawnee, KS, United States

King L.E.,Pfizer | Farley E.,Quintiles | Imazato M.,Novartis | Keefe J.,Biogen Idec | And 4 more authors.
AAPS Journal | Year: 2014

The L4 Global Harmonization Team on reagents and their stability focused on the management of critical reagents for pharmacokinetic, immunogenicity, and biomarker ligand binding assays. Regulatory guidance recognizes that reagents are important for ligand binding assays but do not address numerous aspects of critical reagent life cycle management. Reagents can be obtained from external vendors or developed internally, but regardless of their source, there are numerous considerations for their reliable long-term use. The authors have identified current best practices and provided recommendations for critical reagent lot changes, stability management, and documentation. © 2014 American Association of Pharmaceutical Scientists.

KCAS Inc | Entity website

They developed and validated a pharmacokinetics small molecule method for support of my dog GLP toxicology study. KCAS work was high quality, on time, within budget, and they had great/open communication ...

KCAS Inc | Entity website

12400 Shawnee Mission Parkway Shawnee Mission, KS 66216 (913) 248-3000 *protected email*

KCAS Inc | Entity website

KCAS Inc | Entity website

KCAS flow cytometry team supports all aspects of large and small molecule bioanalysis for preclinical and clinical studies. Our experienced scientists provide custom assay development, validation, sample processing and consulting services for a wide variety of applications ...

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