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MATTAWAN, MI June 02, 2009:
Join Dr. Faqi for a stimulating discussion on key aspects of designing and implementing studies that support the use of drugs in the pediatric population. Historically, this data was often derived from the safety data generated from preclinical studies in adult animals and clinical studies in human adults. However, because of the differences in drug safety profiles between immature and mature organ systems, juvenile animal studies should be considered when identified target organ toxicity in adults is also an organ with significant postnatal development.

Webinar participants will have the opportunity to ask questions and discuss relevant issues regarding their own DART research.

Join Dr. Faqi for a stimulating discussion on key aspects of designing and implementing studies that support the use of drugs in the pediatric population. Historically, this data was often derived from the safety data generated from preclinical studies in adult animals and clinical studies in human adults. However, because of the differences in drug safety profiles between immature and mature organ systems, juvenile animal studies should be considered when identified target organ toxicity in adults is also an organ with significant postnatal development.

Highlights of the Webinar

• Implications of the recently issued FDA guidelines, "Guidance for Industry Nonclinical Testing of Pediatric Drug Products"
• Species selection
• Toxicological endpoints (including the reproductive, neurological, skeletal, cardiovascular, respiratory, gastrointestinal, immunological, and renal systems)
• Key regulatory considerations
• Essential differences between the FDA and EMEA guidelines and application of juvenile data in risk management

MPI Research is committed to partnering with Sponsors to get drugs to the market faster. As a global CRO, the company performs preclinical, early clinical, and select clinical studies for the biotechnology, pharmaceutical, medical device, chemical, agricultural, and animal health industries. Learn more the scope of services available at MPI Research at www.mpiresearch.com or e-mail info@mpiresearch.com.


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