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general toxicology

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.

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outsourcing

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.

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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

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I would rather have questions that can’t be answered than answers that can’t be questioned

By Prof. Richard Feynman

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