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Toxicology - PharmaFacts
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Toxicology

Toxicology is defined as the study of the adverse effects of external factors on an organism or a system.   In addition to the study of the agents that might cause toxicity, modern toxicologists are equally interested in the inherent mechanisms that mediate both toxic insult and the biological or environmental sequelae. Thus, all approaches of modern science (molecular biology and genetics, genomics, proteomics, metabolomics, informatics, analytical chemistry, biochemistry, cell biology, behavior and physiology, etc.) are used daily in the field.

Safety is a main factor contributing to the low success rate from preclinical development to first-in-man studies, and eventually to marketing authorization.  The importance of getting this right cannot be overemphasized.  The ICH M3 R2 guidance is a key driver of the non-clinical safety program. Your plan should consider both strategic and predictive aspects of the non-clinical safety program and address the purpose, scope, and timing of a series of non-clinical studies.  We are experts in the design of single dose tolerability screening, dose ranging and repeat dose protocols.  We also know the CROs that conduct these studies.  If you have already generated data and have a problem, we can guide you on what your next course of action should be, whether it is salvagable or do over and what the ramifications are for the success of your program.

You may elect to include a pre-IND meeting with the regulators to verify that your proposed studies will indeed support the clinical plan and marketing approval of new products.  Alternatively you may elect to wait until your toxicology program is essentially complete and use a preIND meeting as a final assurance that what you have done will probably gain approval.  There is no "one size fits all" solution.  Whatever you are considering we can advise you on all of these matters.  Some of our toxicology consultants are veterans when it comes to regulatory submissions.  Some of them have even sat on the ICH committees in the course of the preparation of the guidelines.  So if you are not quite sure how to proceed we can both assist you in the interpretation of the guidance and provide expertise in the preparation of summary documents of data and the appropriate representation to the regulators.