Bioavailability and Bioequivalence Studies Submitted in NDAs and INDs for Orally-Administered Drug Products 2018

Topics

• Review definitions necessary for understanding bioavailability and bioequivalence
• BA/BE for various oral dosage forms will be discussed with regards to INDs, NDAs and for supplements to NDAs. Also, attendees will understand when biowaivers for studies may be granted
• Attendees will gain an understanding of the information that can be generated from these studies that are important in determining the dosage regimen that achieves target drug exposure in all relevant populations
• 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 discuss how BE documentation can be useful during the IND period (for preapproval changes) to compare (1) early and late clinical trial formulations (2) formulations used in clinical trials and stability studies (3) clinical trial formulations and to-be-marketed formulations, if different and (4) product strength equivalence, as appropriate
• This webinar will be helpful to applicants conducting BA/BE studies during the IND period
• Attendees will understand the studies necessary for INDs and the information generated from such studies and how the information may be used to determine the overall clinical development plan and labeling of the product
• This webinar will also discuss conducting BE due to certain major post-approval changes in components, composition, manufacturing sites, etc, and submission of the data in post-approval supplements, will mention guidance documents to be followed and submission of in vitro dissolution, as well as in vivo BE studies for immediate- release and modified-release drug products
• Attendees will understand when certain BA/BE studies are necessary and when it is appropriate to use healthy volunteers, as opposed to patients, to conduct studies
• Attendees will understand the various types of BA and BE studies, including for INDs, as well as pivotal BE studies required to bridge the to-marketed formulation (test) to that used in Phase 3 clinical trials(reference)
• Consideration of studies conducted in certain populations, such as pediatric patients and those with hepatic impairment will be briefly discussed

Who should Attend

• Specialists
• Regulatory Managers
• Production Personnel
• R&D
• Clinical Personnel
• Quality
• Laboratory Personnel