Guide for successful preclinical studies

We developed this guideline to help formulate molecules with poor solubility and oral bioavailability into more drug-like compounds. The approaches described provide effective strategies to obtain the target dose, sufficient to allow the characterization and optimization of the pharmacokinetic, efficacy and safety profile.

 

Our aim is to help you work with our excipients to get the best results possibly reducing the risk of failure later on during development. Contact your local representative to get your copy of the guideline and technical support.

 

 

 

What you will find in our guideline:

Enabling strategies for efficacy, PK and safety evaluation

 

During lead optimization the scientist in preclinical development aims to maximize solubility and exposure of the test compound in animal models.

In this chapter we highlight the appropriateness of our single excipients to enhance the bioavailability of compounds. We further provide ready-to-use platform formulations that were reported efficient in vivo.

Safety and tolerability information

 

Understanding the excipient’s safety and tolerability profile in various species is crucial to prevent unexpected formulation-related effects.

The compilation of our preclinical safety data helps you avoid long literature research and expensive evaluation of safe dosing volumes of Gattefosse excipients.How to correctly assess dosing volumes of excipient blends is also addressed in this chapter.

Handling and dosing recommendations

 

Appropriate excipient handling and proper dosing to animals prevent misinterpretation of study results.

We herein underpin the need for some of our excipients to be handled with care and dosed under specific precautions. Considering these handling procedures and dosing recommendations provide the best practices to assure reliable outcomes.

Excipient summary tables

 

Functional excipients from Gattefosse are highly beneficial when used in enabled formulations for nonclinical evaluation and transfer to humans.

Our excipients are thoroughly characterized and used in various medicines worldwide. Practical information is compiled at the end of this document enabling rapid retrieval of key information: physicochemical properties, regulatory status and precedence of use.