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Gad Consulting Services, with the help of several other individuals and organizations, has recently completed a data mining project to determine the safe dosing level of drug delivery vehicles for in vivo animal studies. A multitude of vehicles and excipients exist and often there are many that meet physical and/or chemical requirements for a particular drug or compound formulation but the vehicle(s) used also need to be well tolerated by the study animals. Tolerance varies considerably based on the particular dosing route, animal, and dose level and information on this is often scattered and rarely comprehensive. Therefore, this represents an area where wide-ranging yet integrated information is lacking for all those involved. Gad Consulting Services and the organizations credited below analyzed the results from the control groups of studies performed from 1991 to present, using the information available to the individual organizations. The results include information on 65 different vehicles and 9 animal species. There is also a table indicating safe dose volumes and some recommended pH ranges. This information has been made freely available as a service to the industry: Vehicles for Animal Studies (Excel spreadsheet, last updated June 25, 2007) and has also been published in the International Journal of Toxicology, Volume 25, Issue 6. The article is by Shayne C Gad PhD, Crystal D Cassidy, Nicolas Aubert, Bart Spainhour, and Heide Robbe and has useful additional information. Considerable work remains to be done in this area. This is a living document and Gad Consulting Services welcomes more information on this subject and is committed to maintaining this free resource. Please contact us at scgad@ix.netcom.com with any information you would like to add. Please note:
Last Updated June 25, 2007 |