Youtor
Designing FirstInHuman Trials for Small Molecules and Biologics
>> YOUR LINK HERE: ___ http://youtube.com/watch?v=oG1_NYcgy3c
Hanan Ghantous covers the role and responsibilities of the pharmacology/toxicology reviewer related to the various components of the Investigational New Drug (IND) phase of drug development. This presentation covers both scientific and regulatory pharmacology/toxicology concepts that are part of the non-clinical submission to an IND/ NDA/BLA. Viewers will gain an understanding of animal studies submitted to support the safety of clinical studies and marketing applications. • ------------------------- • FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products clinical research. • Upcoming training and free continuing education credits: https://www.fda.gov/cdersbia • CDER SBIA 2017 Playlist: • 2017 CDER Small Business and Industry... • LinkedIn: / cder-small-business-and-industry-assistance • Training resources: https://www.fda.gov/cderbsbialearn • Twitter: / fda_drug_info • CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm... • Email: [email protected] • Phone: (301) 796-6707 I (866) 405-5367
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