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Preformulation guide

Guidelines for use of Gattefossé Excipients in preclinical development

In order to assist in the selection of an appropriate vehicle for in vivo non-clinical safety assessment studies, this document has been specifically designed for use by toxicologists, and scientists working at the early stages of formulation development.

 


A candidate vehicle or formula must meet defined performance criteria for use in pre-clinical studies including:

 

  • enable adequate administration of the test substance with little or no effect in test animals attributable to the vehicles
  • must be suitable for the intended route of administration
  • must maintain the stability of the active ingredient, and preferably maximize the systemic bioavailability of the drug.

 

Lipid based drug delivery systems meet these needs, but in order to be used successfully in preclinical assessment one must fully understand their physico-chemical properties in relation to the application/objective at hand, and employ working methods appropriate to each case.

 

This Guideline document provides our key recommendations for best practice and contains easy-to-use reference data tables. We hope that this information will simplify the task and enable researchers to make choices appropriate to their projects; to save time in data searching; and to maximize speed and efficiency in the study design process.

 

PRIVATE ACCESS: Access to this document is controlled.


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