In vivo non-GLP and GLP toxicology

 

In vivo toxicology has central role in assessing the toxicology profile of for example developed drug compounds, manufactured chemicals, novel food ingredients. Understanding and experience in in vivo toxicology experiments, knowledge on possible alternative testing strategies and knowing the various regulatory authorities is needed to plan and conduct toxicological assessments.

In vivo toxicology can be done in both under accredited GLP (Good Laboratory Practice) settings as well as in early non-GLP settings. Non-GP experiments are faster to conduct and less expensive, whilst regulatory toxicology and safety studies conducted under the GLP settings are needed in e.g. drug discovery/preclinical and clinical development, novel functional food ingredient and REACH chemical safety testing.

The goals of the nonclinical safety evaluation include: A characterization of toxic effects with respect to target organs, dose dependence, relationship to exposure, and potential reversibility. This information is important for the estimation of an initial safe starting dose for the human trials and the identification of parameters for clinical monitoring for potential adverse effects.

Tox Screen early non-GLP toxicology

Tox Screen is a service for screening lead series or different dose levels based on their in vivo toxicological properties in rodents. This service has been designed to yield data that allow elimination of unsuitable compounds early at the discovery stage and also to provide input for planning regulatory toxicological studies.

Please follow these links for the Tox screen in mice service
Tox_screen_mouse_fs Send Tox_screen_mouse_fs sample report Send Tox_screen_mouse_fs offer

Please follow these links for the Tox screen in rats service
Tox_screen_rat_fs Send Tox_screen_rat_fs sample report Send Tox_screen_rat_fs offer

Maximum tolerated dosein rodents

This study is for identification of Maximum Tolerated Dose of lead compounds in rodents. Our service has been designed to yield valuable data on dose levels for planning regulatory toxicological studies.

The MTD toxicity study is available both as non-GLP and GLP.

Please follow these links for the MTD in mice service
Tox_MTD_mouse_fs Send Tox_MTD_mouse_fs sample report Send Tox_MTD_mouse_fs offer

Please follow these links for the MTD in rats service
Tox_MTD_rat_fs Send Tox_MTD_rat_fs sample report Send Tox_MTD_rat_fs offer

Repeated dose toxicity in rodents

We offer the repeated dose toxicity studies of 7, 14, 28 and 90-days. Repeated dose studies are required for IND submission as well as in other regulated areas. We follow the OECD guidelines for conducting the repeated dose toxicity studies.

The repeated dose toxicity study is available both as non-GLP and GLP.

Please follow this link for the Repeated dose toxicity in rodents service
Send Repeated_dode_tox offer

GLP toxicology

GLP helps to define and standardise the planning, performance, recording, reporting, monitoring and archiving processes within research institutions. All GLP studies are audited and signed by Quality Assurance and are fully in compliance with OECD GLP

Choosing the right GLP toxicology and safety pharmacology studies, making the study protocols and planning the order of the studies requires experience in toxicology, regulatory requirements and background information in the drug discovery, functional food ingredients and chemical safety industries. We provide tailored study plans and strategies as well as regulatory experience with Eurotox accredited personnel with extensive experience in the field.

We provide OECD GLP toxicology studies, like acute toxicity, repeated dose toxicity, safety pharmacology, toxicokinetics, chronic toxicity, carcinogenicity, allergenicity/hypersensitivity tests etc.

Please follow these links for the GLP toxicology services
GLP_safety_fs Send PK offer

Long experience and understanding in toxicology in important to ensure only right tests are done in the correct order for each project. Contact us from this link for more information or tailored studies.