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Knowing where to begin or where to go can make all the difference in the world when planning or revising your compound development program. Whether it’s guidance about the FDA’s perspective or explaining results from a study to plan your next move, we can help. Our consulting team, led by Dave Buckley, has a strong history of experience and unsurpassed expertise regarding metabolism-related issues. Invest your time and money wisely; let XenoTech consulting guide you in the right direction for all of your drug development needs!
XenoTech Consulting can help navigate your compound development with the following services:
- Review all study-related data conducted at XenoTech
- Recommend additional studies necessary to satisfy an IND submission
- Provide advice on the interpretation of pre-clinical ADME-Tox data and its extrapolation to the clinical setting, with special emphasis on in vitro-in vivo extrapolation (IVIVE) and an evaluation of the victim and perpetrator potential of a drug candidate
- Prepare expert opinion papers on ADME-Tox issues
- Review or prepare material for Investigator’s Brochures
- Prepare responses to questions from the FDA and other regulatory agencies
- Attend in a consulting capacity FDA Advisory Board meetings and FDA hearings
- Deliver lectures on special topics, including basic courses on drug metabolism
Click here to find out how XenoTech Consulting can help you.