Assessment of low volume sampling technologies: utility in nonclinical and clinical studies

Author:

Williams Kathi J1,Lutman Jeff2,McCaughey Cynthia3,Fischer Saloumeh K1

Affiliation:

1. Assay Development & Technology, Genentech, Inc., South San Francisco, CA 94080, USA

2. Preclinical & Translational Pharmacokinetics, Genentech Inc., South San Francisco, CA 94080, USA

3. Safety Assessment, In Vivo Studies, Genentech Inc., South San Francisco, CA 94080, USA

Abstract

Background: Low volume sampling technologies have come a long way; however, their uptake has been slow due to logistical and perceived implementation challenges. Additional studies are needed to overcome these barriers. Materials & methods/results: Here we present two studies where different sampling technologies were evaluated to determine the feasibility of their implementation. First, we evaluated pharmacokinetic profiles for anti-gD in rats using three tail bleed sampling methods, glass capillary tubes, Shimadzu MSW2® and the Neoteryx Mitra® microsampler. Second, we evaluated two low volume-sampling methods to measure drug levels from patients treated with anti-A therapeutic. This evaluation used whole blood finger pricks for Neoteryx Mitra and plasma from capillary blood using TASSO OnDemand technology to compare results to established venipuncture collection method. Conclusion: These studies evaluate the feasibility and considerations for implementation of different low volume sampling technologies.

Funder

Genentech Inc

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

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