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NDAs and INDs for Orally-Administered Drug Products

Online

Wednesday, February 28, 2018

 

 

Overview: This webinar will be helpful to applicants conducting BA/BE studies during the IND period, also FDA guidance recommendations on how to meet the BA and BE requirements in 21 CFR 320 as they apply to oral dosage forms. Why should you Attend: Understanding when Bioavailability and Bioequivalence studies should be done can help attendees avoid having to re-do clinical trials, help to determine dosage regimen that achieves target drug exposure. Areas Covered in the Session: Review definitions necessary for understanding bioavailability and bioequivalence Review of FDA guidance recommendations on how to meet the BA and BE requirements in 21 CFR 320 as they apply to oral dosage forms. This webinar will be helpful to applicants conducting BA/BE studies during the IND period. Who Will Benefit: Regulatory Managers Specialists R&D Production Personnel Quality Clinical Personnel Laboratory Personnel Speaker Profile: Stephanie Cooke is the President/CEO of Cooke Consulting, Inc. Stephanie uses her roughly 20 years of experience to provide global consulting services in various areas of Regulatory Affairs, Quality Assurance and validation for pharmaceutical, biological/biotech products, medical device, combination drug/device and nutraceutical firms. Event Fee: One Dial-in One Attendee Price: US$150.00 Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com

 

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