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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-human-drugs/advancing-generic-drug-development-translating-science-approval-09212021-09222021
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