Impurity Case Studies: Pharmacology/Toxicology (22of28) Generic Drugs Forum – Apr. 3-4, 2019 скачать в хорошем качестве

Impurity Case Studies: Pharmacology/Toxicology (22of28) Generic Drugs Forum – Apr. 3-4, 2019

CDER’s Office of Pharmaceutical Quality’s Hongbio Liao and Office of Generic Drugs’ Victoria Keck discuss impurities. A top RTR is due to impurity issues. Liao and Keck cover FDA adequate and inadequate impurity submissions. They also troubleshoot impurity challenges to include Potential Genotoxic Impurity (PGI) assessment in Type II DMFs as well as safety justifications for impurities exceeding International Conference on Harmonisation (ICH) limits in ANDAs. Learn more at https://www.fda.gov/drugs/cder-small-... _______________________________ FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Visit https://www.fda.gov/cdersbia and https://www.fda.gov/cdersbialearn for news and a repository of training activities. Email: CDERSBIA@fda.hhs.gov Phone: (301) 796-6707 I (866) 405-5367 LinkedIn:   / cder-small-business-and-industry-assistance   Twitter:   / fda_drug_info   CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm...