In Vitro Drug Release Testing for LA Drug Products QC (16of35) Complex Generics - Sep. 25-26, 2019 скачать в хорошем качестве

In Vitro Drug Release Testing for LA Drug Products QC (16of35) Complex Generics - Sep. 25-26, 2019

Vidula Kolhatkar, from CDER Office of Pharmaceutical Quality’s Division of Biopharmaceutics, discusses the current approach to in vitro release test (IVRT) to include product specific in vitro release test, discriminating ability, and acceptance criteria. She also shares common deficiencies and steps forward. 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...