BR38, a new ultrasound blood pool agent.

Objective: : To evaluate BR38, a new microbubble-based blood pool agent for contrast-enhanced ultrasound imaging.

Materials And Methods: : The size characteristics of BR38 microbubbles were measured by Coulter counting. The backscatter and attenuation coefficients were determined as a function of frequency.

Society of Toxicologic Pathology position paper on pathology image data: compliance with 21 CFR Parts 58 and 11.

The Society of Toxicologic Pathology (STP) has developed the following recommendations for the use of pathology images in compliance with the Code of Federal Regulations (CFR), Volume 21, Part 58 (Good Laboratory Practices [GLP]) and Part 11 (Electronic Records/Signatures). These recommendations include: (1) based on current technologies and practices, pathology images (printed, electronic, or digital) used for data generation (e.g.

Toxicological assessment of gadolinium release from contrast media.

In vivo gadolinium release was evaluated for MultiHance, Omniscan and Gadovist estimating gadolinium content in liver, kidneys, spleen, femur and brain after single or repeated intravenous administrations to rats at 1 mmol/kg. Gadolinium acetate (GdAc) at a daily dose of 0.03 mmol/kg and physiological saline were used as positive and negative controls, respectively.

Society of Toxicologic Pathology position on histopathology data collection and audit trail: compliance with 21 CFR parts 58 and 11.

The purpose of this paper is to discuss the requirement of the audit trail to track changes made to the histopathology data, in order to be compliant with the Code of Federal Regulations (CFR), Volume 21, for both Part 58 (Good Laboratory Practices [GLP]) and Part 11 (Electronic Records/Signatures).