Annual Meeting of the Japanese Society of Toxicology
The 49th Annual Meeting of the Japanese Society of Toxicology
Session ID : S19-6
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Symposium 19
The use of capillary microsampling in GLP toxicology studies: experience at Janssen R&D
*Tom VERHAEGHE
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CONFERENCE PROCEEDINGS FREE ACCESS

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Abstract

About a decade ago, microsampling was introduced for blood collections from small lab animals (rat, mouse) in safety studies at Janssen R&D to refine the sampling procedure and reduce the number of animals. Capillary microsampling (CMS) was selected as the method of choice, enabling the collection of an accurate 10 microliter plasma sample. Initially, the technique was evaluated in non-GLP studies. The experience gained in these studies was used to also introduce the technique in the majority of the GLP studies about 7 years ago. One of the challenges was to introduce CMS in studies outsourced to contract labs because of the limited experience at CROs. The technique has also been challenged by a regulatory authority and a bridging study was set up to demonstrate that the sampling technique does not impact the TK parameters.

More recently CMS was also introduced for the sampling of larger lab animals (rabbit, mini-pig) because of the ease of blood sampling.

The presentation will focus on some of the challenges we faced in implementing the technique and demonstrate the benefits on animal wellbeing and study cost.

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