Vehicles for Animal Studies
Gad Consulting Services, with the help of several other individuals and organizations, in 2006 completed a data mining project to determine the safe dosing level of drug delivery vehicles for in vivo animal studies. In 2015 we endeavored to update the resource, and the updated publication was published online ahead of print by the International Journal of Toxicology in January of 2016:
Shayne C. Gad, Ph.D., DABT, Charles B. Spainhour, DVM, DABT, Catherine Shoemaker, DVM, Danielle R. Stackhouse Pallman, B.S., C.V.T., Alain Stricker-Krongrad, PhD, MS, Philip A. Downing, B.A., Richard E. Seals, Ph.D., DABT, Leslie A. Eagle, Kara Polhamus, B.S., LATG, and Jennifer Daly, B.S. (2016) Tolerable Levels of Nonclinical Vehicles and Formulations Used in Studies by Multiple Routes in Multiple Species With Notes on Methods to Improve Utility. Int J Toxicol, 1091581815622442, first published on January 10, 2016. View publication.
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 as well as information available in the literature. The results identiﬁed 108 single component vehicles used in more than 600 studies across multiple species by multiple routes for a range of durations, and also including data on 306 combination vehicles. Also included are a review of available literature on each vehicle, as well as guidance on volume limits and pH by route and some basic guidance on nonclinical formulation development, as well as guidance on factors to be considered in nonclinical route selection. This information has been made freely available as a service to the industry: Vehicles for Animal Studies (Excel spreadsheet, last updated January, 2016) and has also been published online ahead of print by the International Journal of Toxicology. Considerable work remains to be done in this area. This is a living document and Gad Consulting Services continues to add to the database, welcomes more information on this subject and is committed to maintaining this free resource. Please contact us at email@example.com with any information you would like to add. Please note:
- Information sent will be added to the spreadsheet, so please do not send proprietary or confidential material. Most will come from control (vehicle) group animals.
- Please include all information in the tables (if possible): Animal, Route, Formulation, Time, Maximum NOAEL Dose, and Dose Limiting Toxicities.
- Please be succinct – the easier it is to understand, the faster the updates will be entered.
- We will give credit if so desired – or not if that is the contributor’s wish.
Special thanks go to the following persons for their contributions to this project:
- Nicolas Aubert – CIT Safety and Health Research Laboratories, Evreux, France
- Bart Spainhour – Calvert Laboratories, Olyphant, PA
- Danielle R. Stackhouse-Pallman – Calvert Laboratories, Olyphant, PA
- Heide Robbe – MPI Research, Mattawan, MI
- Kara Polhamus – MPI Research, Mattawan, MI
- Jennifer Daly – MPI Research, Mattawan, MI
- Catherine Shoemake – Sinclair Laboratories, Columbus, MO
- Alain Stricker-Krongrad – Sinclair Laboratories, Columbus, MO
- Philip A. Downing – BASi Laboratories – Mount Vernon, IN
- Richard E. Seals – BASi Laboratories – Mount Vernon, IN