Attendees that need to perform bioavailability (BA) and bioequivalence (BE) studies for INDs, NDAs or for NDA supplements should attend this training. They will learn the requirements of such studies, per 21 CFR 320 and all other relevant regulatory documents.
This webinar will discuss how to apply all relevant regulatory requirements for establishing the necessary BA and BE studies for INDs, NDAs and supplements to NDA. Attendees will understand the use of BE studies for ANDAs for generic products, as this topic will be addressed very briefly to discuss the differences between BE studies for ANDAs and studies required for INDs, NDAs and post-approval filings. Attendees will also 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.
Attendees will also learn what information can be generated from these studies that are important in determining the dosage regimen that achieves target drug exposures in all relevant populations. Also learn the various types of BA and BE studies, including for INDs, as well as pivotal BE studies required to bridge the to-be-marketed formulation (test) to that used in Phase 3 clinical trials (reference), Fed and fasting studies and other specific criteria, timing and information generated based on these studies and its use.
- 21 CFR 320, Bioavailability and Bioequivalence Requirements, FDA, ICH and all other regulations addressing bioavailability (BA) and bioequivalence (BE) studies for investigational drugs, new drugs and modified drugs and for INDs, NDAs and supplements to NDAs
- Definitions/information necessary to understand BA/BE studies and the purpose of such studies during different stages of the lifecycle of a product
- BA/BE studies for various dosage forms
- Discuss when BA/BE studies are needed for INDs, NDAs and NDA supplements
- Specific studies, such as those necessary for INDs
- Specific BA/BE studies necessary at different times during the phases of drug development or when certain changes are made, or when studies need to be done to generate necessary data
- Information that may be attained from IND studies and the impact of such information on the clinical development program
- Criteria for biowaivers of BA/BE studies
- BE studies for ANDAs, while not the specific topic addressed during this webinar, will be briefly addressed
- Regulatory personnel
- Clinical trials
- Auditing of clinical trial sites and clinical trial data
- Product development
- Product labeling
- Personnel that are responsible for educating consumers or healthcare personnel on product use
- Personnel responsible for evaluating possible adverse events
- Personnel responsible for the review of advertising and promotional material