Identification of Target Organs in order to Support Risk Assessments
An American Board-certified Toxicologist is trained to support customers from the Proof of Concept experimental designs (POC) till the Long term Toxicity studies incl. carcinogenicity studies in rodents.
We are trained to guide through their milestones of small till large Toxicology programs
we are trained to advice about key decisions & avoiding the common but also rare pitfalls
Because each R&D compound is different, An American Board-certified Toxicologist is trained to adapt drug development strategies in Function of the compound.
The Strategy of Outsourcing
A Board-certified Toxicologist is trained to manage outsourcing process using world-wide gold standard references CRO’s in which I have build my Career till today and still have personal contacts.
A Ideal Job description of a Senior Toxicologist could be as follows:
Advising about the CRO selection in function of your personal & technical needs
connecting with the respective Boards in order to provide you a reliable prompt communication
revisions quotation, protocol, amendement, reporting, iND packages
reacting to Unforeseen adversities and advise Successful strategies
monitoring on site for you or together with you
communicating & traveling upon demand
acting as your liaison with CRO’s: streamline deliveries, Standardise results & reporting
explaining all steps of the process from Administration till necropsy, Microscopic evaluations and IND reporting towards regulatory authorities in Europe and FDA.
TYPES OF STUDIES
all species: mouse, rat, rabbit, dog, minipig & non-human primate
genetically modified species
Customise designs, protocols, studies & Toxicology programs
non-GLP proof of concept, dose range finding, local tolerance
gLP acute, subacute and Chronic studies
2-week toxicology studies
4-week toxicology studies
3-months, 6-months, 9-months and 2-years toxicology studies
tissue cross reactivity studies as needed
I would rather have questions that can’t be answered than answers that can’t be questioned
By Prof. Richard Feynman