NanoViricides Inc. (NNVC)

[changes_iv]

FluCide GLP full tox study and BASi

BASi has the Culex-L (large animals) and Culex ABC (for small animals).

From the International Society of Study of Xenobiotics

The aim of the current research was to demonstrate that pharmacokinetic data in plasma and Dried Blood Spots (DBS) can yield equivalent results. Four male beagle dogs were implanted with a subcutaneous access port (VAP) with a catheter inserted into the femoral vein. After surgery the dogs were allowed to recover 7 days. During the recovery period the dogs were acclimatized to metabolism cages and dog jackets for 2 hours a day. On the study start day the dogs were placed in jackets and individual metabolism cages. The dogs were connected to the Culex-L automated blood collector (Culex-L ABC), a computer-controlled robotic blood collection system, and dosed once orally with 50 mg/kg of acetaminophen. Samples of 600 ?L whole blood were collected into chilled vials prior to dosing and at 0.5, 1, 2, 4, 6 and 8 hours post dosing. Within two hours after collection, four 20 ?L spots of whole blood from each time point were pipetted onto Culex DBS collection cards. The DBS cards were allowed to air dry overnight at room temperature and stored at room temperature in a sealed bag containing a desiccant. The remaining blood was processed to plasma and frozen. Twenty eight whole blood samples were collected, seven from each dog. Twelve samples were several minutes later than scheduled (from 5 to 14min) due to either a software problem, or dislodgement of the needle accessing the VAP. Samples were analyzed by liquid-liquid extraction with separation and detection by LC-MS/MS. The pharmacokinetic profiles from each sampling method indicate that there is no difference between the sampling techniques. The mean concentrations from both sampling methods across the time points were indistinguishable. DBS methods offer many advantages for the collection, storage and shipping of blood samples for drug analysis. Smaller volume of sample is required for analysis allowing more frequent and multiple samples compared to a traditional PK method. Processing, handling, and shipping of DBS samples is less time consuming, less laborious, and incurs lower cost than frozen plasma. Automation of the blood sampling and delivery process ensures consistent volume, quality and location of DBS samples on the collection cards. It can also reduce labeling and handling of the cards.

https://issx.confex.com/issx/17NA/webprogram/Paper25960.html

Other related:

A modern in-vivo pharmacokinetic paradigm
http://www.gnf.org/assets/002/23097.pdf

Snapshot PK: a rapid rodent in vivo preclinical screening approach
http://www.gnf.org/assets/001/23052.pdf

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