Bioavailability and Bioequivalence Studies submitted in NDAs and INDs

Why Should You Attend:

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.

Areas Covered in the Webinar:

• 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

Who Will Benefit:

• 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

Stephanie Cooke
Consultant, Cooke Consulting, Inc

Stephanie Cooke is the President/CEO of Cooke Consulting, Inc., using her 20 years of experience to provide global consulting services in various areas of Regulatory Affairs, Quality Assurance and validation for pharmaceutical, biopharmaceutical, medical device and nutraceutical firms. Her broad-based experience includes preparation of regulatory dossiers for human and animal pharmaceutical and biotech products, drug/device combination products and medical devices in all stages of development (INDs, NDAs, post-marketing, orphan drug submissions, 510ks, PMAs and HDEs). She also has extensive QA and validation experience, hosting many compliance audits conducted by FDA, ISO and other international regulatory bodies, conduct/management of auditing program to qualify contract manufacturers and vendors of raw materials, APIs, product release experience in manufacturing environments and for companies using contract manufacturers, responsibility for QMS for all product types (CAPA, Complaint, Document Control systems), stability programs, as well as preparation/performance of manufacturing process validation, sterilization validation (EtO, steam, gamma), aseptic processing, qualification of cleanrooms/water systems and qualification of equipment.

Stephanie worked for Scīele Pharma from 2005-2009 and was VP of Regulatory Affairs, Quality Assurance/Validation for Scīele, leaving in 2009 to start Cooke Consulting. She also held various senior RA, QA and validation positions at Merial, Bayer, Cryolife, Theragenics and other pharmaceutical, biotech and device companies, after beginning in industry as a lab tech and as a certified as a Microbiologist. She has a BS in Biology and an M.S. in Molecular Genetics and Biochemistry.

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