Considerations in Assessing Generic Drug Products of Oral Dosage Forms скачать в хорошем качестве

Considerations in Assessing Generic Drug Products of Oral Dosage Forms

FDA discusses considerations in assessing generic drug products of oral dosage forms. Includes responses to audience in a question-and-answer panel. Presenters and presentations include: Nasal Pharmacokinetic Study of Abuse-Deterrent Oxycodone HCl ER Products Following Insufflation of Physically Manipulated Products Saeid Raofi, MS; DTP II|ORS|OGD|CDER Advancement in the In-Vitro Evaluation of Abuse-Deterrent Formulations for Opioid Analgesics: Research and Assessment Perspectives Manar Al-Ghabeish, PhD; DPQR|OTR|OPQ|CDER Physiological Based Pharmacokinetic Modeling and Simulation Absorption Modeling and Virtual Bioequivalence to Support Generic Drug Development and Regulatory Decision Making for Oral Products Fang Wu, PhD; DQMM|ORS|OGD|CDER Safety Assessment of Flavors in Generic Drug Products Melanie Mueller, PharmD, PhD; DPTR|OSCE|OGD|CDER Q&A Panel (Including all above presenters): Xiaoming Xu, PhD; DPQR|OTR|OPQ|CDER Heather Boyce, PhD; DTP II|ORS|OGD|CDER For slides and additional information: https://www.fda.gov/drugs/news-events... --------------------  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 - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2021 Playlist -    • 2021 CDER Small Business and Industry Assi...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - [email protected] Phone - (301) 796-6707 I (866) 405-5367